PP405

updated

PP405 is an investigational topical gel from Pelage Pharmaceuticals for androgenetic alopecia, built on mouse work showing that raising lactate activates hair follicle stem cells. A completed phase 2a in 78 adults posted safety results and plasma PP405 of 0 ng/mL, and a 600-man phase 2/3 efficacy study began recruiting on 21 September 2026. No published human efficacy result exists: the only human hair figure is an exploratory subgroup statement in a company press release.

Mitochondrial pyruvate carrier (MPC) inhibitor, by structure

  • No approval was found: openFDA Drugs@FDA returned no record and DailyMed returned no label for PP405, suvomipic or JXL069 on 10 October 2026.
  • PubChem lists PP405, PP-405, JXL069, JXL-069 and suvomipic as synonyms of one record (CID 137374808), a structure that matches the JXL069 analogue in a 2021 medicinal chemistry paper.
  • The phase 2a safety study (NCT06393452) randomized 78 adults with androgenetic alopecia; at least one adverse event occurred in 22 of 51 on PP405 0.05% gel and 10 of 27 on vehicle, and the registry reports plasma PP405 of 0 ng/mL with no detection limit posted.
  • The company reported in a 17 June 2025 press release that at week 8, 31% of PP405-treated men with a higher degree of hair loss had a hair density increase of more than 20%, versus 0% on placebo, an exploratory subgroup result with no denominators.
  • A phase 2/3 study (NCT07819435, 600 men estimated) began recruiting on 21 September 2026, with a primary outcome of week-24 target area hair count and no results.
  • In ex vivo human scalp follicles the MPC inhibitor UK-5099 caused proliferative arrest, the opposite of the mouse result, and it tested UK-5099, not PP405.

What is PP405, and has anyone approved it?

PP405 is an investigational topical gel for androgenetic alopecia from Pelage Pharmaceuticals, with the same structure as JXL069, a compound described in cells and mice. No approval was found: openFDA returned no record and DailyMed no label for PP405, suvomipic or JXL069 on 10 October 2026.

PP405 resolves in PubChem to CID 137374808 (C20H11F6N3O2, 439.3 g/mol, CAS 2260696-63-5, IUPAC name (E)-3-[1-[[3,5-bis(trifluoromethyl)phenyl]methyl]pyrrolo[2,3-b]pyridin-3-yl]-2-cyanoprop-2-enoic acid). PubChem lists PP405, PP-405, JXL069, JXL-069 and suvomipic as synonyms of the same record. The structure is a cyanoacrylic acid on a 7-azaindole with a 3,5-bis(trifluoromethyl)benzyl group, which matches the JXL069 analogue described in a 2021 medicinal chemistry paper, so the page treats them as the same structure. The registered trials use PP405 as a 0.05% topical gel.

openFDA Drugs@FDA returned no record and DailyMed returned no label for PP405, suvomipic or JXL069, all on 10 October 2026. The compound is in registered trials sponsored by Pelage Pharmaceuticals.

PubChem: PP405 identity, synonyms and structure

Chemical identity record

National Library of Medicine. PubChem compound record CID 137374808 (PP405).

PP405 resolves in PubChem to CID 137374808, C20H11F6N3O2, 439.3 g/mol, CAS 2260696-63-5, IUPAC name (E)-3-[1-[[3,5-bis(trifluoromethyl)phenyl]methyl]pyrrolo[2,3-b]pyridin-3-yl]-2-cyanoprop-2-enoic acid. PubChem lists PP405, PP-405, JXL069, JXL-069 and suvomipic as synonyms of the same record. The structure is a cyanoacrylic acid on a 7-azaindole with a 3,5-bis(trifluoromethyl)benzyl group, which matches the JXL069 analogue described in a 2021 medicinal chemistry paper. The registered trials use PP405 as a 0.05% topical gel.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Searches, 10 October 2026: no FDA record or label, 2 PubMed records, no peer-reviewed human trial

PubMed search record

openFDA Drugs@FDA and DailyMed searches for PP405, suvomipic and JXL069, a PubMed search PP405[tiab] OR JXL069[tiab] OR suvomipic[tiab] OR "PP-405"[tiab] (2 records), and a ClinicalTrials.gov search for PP405 (2 records), all run on 10 October 2026.

openFDA Drugs@FDA returned no record and DailyMed returned no label for PP405, suvomipic or JXL069. The PubMed search returned 2 records: the 2021 medicinal chemistry paper and the 2026 review. No peer-reviewed report of a human trial of PP405 was found. ClinicalTrials.gov returned 2 PP405 records (the phase 2a and the phase 2/3). The registry text refers to an earlier phase 1 trial, PP405-001, and no registration for it was found.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature, registry and FDA record search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

What has been reported from studies in people?

A completed phase 2a safety study in 78 adults posted adverse events in 22 of 51 on PP405 and 10 of 27 on vehicle, and plasma PP405 of 0 ng/mL, with no efficacy outcome. No published human efficacy result exists, and a phase 2/3 efficacy study began recruiting on 21 September 2026.

The phase 2a study (NCT06393452, Pelage Pharmaceuticals, results first posted on 22 September 2026) randomized 78 adults aged 18 to 55 with androgenetic alopecia: 51 to PP405 0.05% gel once daily for 28 days with follow-up to day 84, and 27 to vehicle. Twenty vehicle participants then took PP405 in an open-label extension for 84 days. The registry allows all sexes. Its registered outcomes are safety and pharmacokinetics only, with no efficacy outcome, so it does not show whether PP405 grows hair.

A phase 2/3 efficacy and long-term safety study (NCT07819435, first posted on 15 September 2026, start 21 September 2026, 600 estimated) is recruiting. It randomizes men aged 18 to 55 in the United States and Canada 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24 and a 52-week design with re-randomization of the vehicle group. No results exist. A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

A PubMed search on 10 October 2026 for PP405, JXL069 or suvomipic returned 2 records, the 2021 medicinal chemistry paper and a 2026 review, and no peer-reviewed report of a human trial of PP405 was found. The registry text refers to an earlier phase 1 trial, PP405-001, and no registration for it was found. A 2026 review places PP405 among the metabolic and follicular activators in development and gives no PP405 trial numbers.

Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Phase 2/3, 600 men estimated: recruiting since 21 September 2026, no results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT07819435.

A phase 2/3 efficacy and long-term safety study is registered and recruiting (Pelage, first posted on 15 September 2026, start 21 September 2026, 600 estimated): men aged 18 to 55 in the United States and Canada randomized 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24, and a 52-week design with re-randomization of the vehicle group. No results exist.

Participants / model
600 men with androgenetic alopecia aged 18 to 55 (estimated, recruiting), in the United States and Canada
Treatment
Topical PP405 0.05% gel versus vehicle, randomized 1:1
Follow-up
52 weeks planned; primary outcome at week 24
Study design
Phase 2/3 randomized vehicle-controlled study, recruiting, no results
Funding
not stated in the source

A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

Read the original source
Searches, 10 October 2026: no FDA record or label, 2 PubMed records, no peer-reviewed human trial

PubMed search record

openFDA Drugs@FDA and DailyMed searches for PP405, suvomipic and JXL069, a PubMed search PP405[tiab] OR JXL069[tiab] OR suvomipic[tiab] OR "PP-405"[tiab] (2 records), and a ClinicalTrials.gov search for PP405 (2 records), all run on 10 October 2026.

openFDA Drugs@FDA returned no record and DailyMed returned no label for PP405, suvomipic or JXL069. The PubMed search returned 2 records: the 2021 medicinal chemistry paper and the 2026 review. No peer-reviewed report of a human trial of PP405 was found. ClinicalTrials.gov returned 2 PP405 records (the phase 2a and the phase 2/3). The registry text refers to an earlier phase 1 trial, PP405-001, and no registration for it was found.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature, registry and FDA record search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source
2026 review: PP405 among the metabolic and follicular activators in development

Human study

Agrawal A et al. Expert Opin Pharmacother. 2026;27(10):929-939. PMID 42290527.

A 2026 review of emerging androgenetic alopecia pharmacotherapies places PP405 among the metabolic and follicular activators in development, alongside other compounds. The abstract gives no PP405 trial numbers.

Participants / model
Review of the androgenetic alopecia pipeline
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative review
Funding
not stated in the source

A pipeline description, not a trial report.

Read the original source

What did the company say about hair density?

The company reported that at week 8, 31% of PP405-treated men with a higher degree of hair loss had a hair density increase of more than 20%, versus 0% on placebo. It is an exploratory subgroup result with no denominators, hair count or p value.

A Pelage Pharmaceuticals press release published on 17 June 2025 (a BioSpace copy of the BusinessWire release) said the same 78-person study met its safety and pharmacokinetic endpoints, with no systemic absorption detected in blood. The company described hair density as an exploratory endpoint and reported that at week 8, 31% of PP405-treated men with a higher degree of hair loss had an increase in hair density of more than 20%, versus 0% on placebo.

The release gives no number of men in that subgroup, no hair count result and no p value, and the registered outcomes do not include hair density. It is a company statement, not a peer-reviewed result. The company said it expected to start phase 3 studies in 2026.

Company statement, 17 June 2025: exploratory subgroup, 31% versus 0% with a density increase over 20%

Regulatory record

Pelage Pharmaceuticals. Press release published 17 June 2025 announcing phase 2a clinical trial results for PP405 (BioSpace copy of the BusinessWire release).

The company reported that the same 78-person study met its safety and pharmacokinetic endpoints, with no systemic absorption detected in blood. It described hair density as an exploratory endpoint and said that at week 8, 31% of PP405-treated men with a higher degree of hair loss had an increase in hair density of more than 20%, versus 0% on placebo. The release gives no number of men in that subgroup, no hair count result and no p value, and the registered outcomes do not include hair density. The company said it expected to start phase 3 studies in 2026.

Participants / model
Subgroup of men with a higher degree of hair loss in the 78-person phase 2a study
Treatment
Topical PP405, once daily for 4 weeks, follow-up to 12 weeks
Follow-up
Follow-up to 12 weeks; the subgroup result is at week 8
Study design
Company press release (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own statement of an exploratory subgroup result, with no denominators.

Read the original source

What do the mouse studies show?

In mice, raising lactate activated hair follicle stem cells and sped the hair cycle, and a compound with the PP405 structure inhibited the mitochondrial pyruvate carrier and regrew hair on shaved mice. These are animal and cell findings, mostly from the developer's group.

The founding paper reports that in mice, hair follicle stem cells use glycolysis and make more lactate than other epidermal cells. Deleting lactate dehydrogenase (Ldha) prevented their activation, and deleting the mitochondrial pyruvate carrier 1 (Mpc1) to raise lactate speeded stem cell activation and the hair cycle. The authors also identified small molecules that raise lactate by stimulating Myc or by inhibiting Mpc1 carrier activity and that induced the hair cycle when applied to the skin. The paper discloses patent filings by the University of California and a license to Carthronix LLC, in which one author holds a shareholding and advisory role.

A 2021 medicinal chemistry paper from the same UCLA group reports analogues of the MPC inhibitor UK-5099 (JXL001). Inhibitors with a 3,5-bis(trifluoromethyl)benzyl group at the N1 position raised cellular lactate production much more than JXL001, and JXL069, a 7-azaindole, showed significant MPC inhibition activity. More than 10 analogues, not named in the abstract, promoted hair growth on shaved mice after topical treatment. This ties the PP405 structure to MPC inhibition in cells and mice.

A further study in mouse alopecia models (aging, repeated chemotherapy, stress) found that inhibiting pyruvate transport into mitochondria accelerated the hair cycle, with histologically normal follicles within 30 to 40 days and no overt toxicity. One author is affiliated with Pelage Pharmaceuticals, and the abstract does not state the route. All of this is mouse work, not human.

Mouse study: raising lactate activated hair follicle stem cells and the hair cycle

Animal study

Flores A et al. Nat Cell Biol. 2017;19(9):1017-1026. PMID 28812580.

In mice, hair follicle stem cells use glycolysis and make more lactate than other epidermal cells. Deleting lactate dehydrogenase (Ldha) prevented their activation, and deleting the mitochondrial pyruvate carrier 1 (Mpc1) to raise lactate speeded stem cell activation and the hair cycle. The authors also identified small molecules that raise lactate by stimulating Myc or by inhibiting Mpc1 carrier activity and that induced the hair cycle when applied to the skin.

Participants / model
Mice
Treatment
Genetic deletion, and small molecules applied to the skin
Follow-up
not stated in the source
Study design
Primary mechanistic study in mice
Funding
not stated in the source

This is mouse work, not human. The paper discloses patent filings by the University of California and a license to Carthronix LLC, in which one author holds a shareholding and advisory role.

Read the original source
2021 chemistry paper: JXL069, a 7-azaindole, inhibited MPC; analogues regrew hair on shaved mice

Animal study

Liu X et al. J Med Chem. 2021;64(4):2046-2063. PMID 33534563.

A 2021 medicinal chemistry paper from the same UCLA group reports analogues of the MPC inhibitor UK-5099 (JXL001). Inhibitors with a 3,5-bis(trifluoromethyl)benzyl group at the N1 position raised cellular lactate production much more than JXL001, and JXL069, a 7-azaindole, showed significant MPC inhibition activity. More than 10 analogues, not named in the abstract, promoted hair growth on shaved mice after topical treatment.

Participants / model
Cell assays and shaved mice
Treatment
Topical small molecules in mice
Follow-up
not stated in the source
Study design
Primary medicinal chemistry paper (cell and animal)
Funding
not stated in the source

This ties the PP405 structure to MPC inhibition in cells and mice. It is not human data.

Read the original source
Mouse alopecia models: normal follicles in 30 to 40 days, developer-affiliated author

Animal study

Flores A et al. Exp Dermatol. 2021;30(4):448-456. PMID 33739490.

In mouse alopecia models (aging, repeated chemotherapy, stress), inhibiting pyruvate transport into mitochondria accelerated the hair cycle, with histologically normal follicles within 30 to 40 days and no overt toxicity.

Participants / model
Mice (aging, chemotherapy and stress alopecia models)
Treatment
Pyruvate transport inhibition (route not stated in the abstract)
Follow-up
30 to 40 days
Study design
Primary animal study, developer-affiliated
Funding
not stated in the source

One author is affiliated with Pelage Pharmaceuticals. This is animal work from the developer's group, and the route is not stated in the abstract.

Read the original source

What happened in human scalp follicles in culture?

In short-term culture of human scalp hair follicles, the MPC inhibitor UK-5099 caused proliferative arrest and stress responses, which does not match the mouse result. It tested UK-5099, not PP405.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells. The gene signature showed disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation, and the ISR inhibitor ISRIB reduced the effect.

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells. It is a reason to treat MPC inhibition as a hypothesis in humans.

Ex vivo human follicles: UK-5099 caused proliferative arrest and stress responses

Cell study

Pye D et al. PLoS One. 2024;19(6):e0303742. PMID 38900734.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells, with a gene signature of disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation. The ISR inhibitor ISRIB reduced the effect.

Participants / model
Human scalp hair follicles in ex vivo organ culture
Treatment
UK-5099 added to the culture medium
Follow-up
Short-term culture
Study design
Primary ex vivo study
Funding
not stated in the source

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells.

Read the original source

Is PP405 the most mechanistically novel hair loss compound, and is it in phase 2 as a topical?

Partly. Topical in phase 2 is accurate: a phase 2a is completed and a phase 2/3 began recruiting on 21 September 2026. Most mechanistically novel is a ranking opinion that no source tests, and the human biology is not settled.

Sellers describe PP405 as the most mechanistically novel hair loss compound in development and as in phase 2 as a topical. The phase part is accurate: the phase 2a is completed, and the phase 2/3 was registered as recruiting from its start on 21 September 2026.

The ranking part is an opinion that no source tests. A defensible statement is that MPC inhibition is a different mechanism from the androgen receptor, 5-alpha-reductase and potassium-channel approaches, and that a 2026 review places PP405 among the metabolic and follicular activators in development, alongside other compounds. The human biology is not settled: the one human follicle study of an MPC inhibitor found proliferative arrest, and no completed efficacy trial exists.

Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Phase 2/3, 600 men estimated: recruiting since 21 September 2026, no results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT07819435.

A phase 2/3 efficacy and long-term safety study is registered and recruiting (Pelage, first posted on 15 September 2026, start 21 September 2026, 600 estimated): men aged 18 to 55 in the United States and Canada randomized 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24, and a 52-week design with re-randomization of the vehicle group. No results exist.

Participants / model
600 men with androgenetic alopecia aged 18 to 55 (estimated, recruiting), in the United States and Canada
Treatment
Topical PP405 0.05% gel versus vehicle, randomized 1:1
Follow-up
52 weeks planned; primary outcome at week 24
Study design
Phase 2/3 randomized vehicle-controlled study, recruiting, no results
Funding
not stated in the source

A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

Read the original source
2026 review: PP405 among the metabolic and follicular activators in development

Human study

Agrawal A et al. Expert Opin Pharmacother. 2026;27(10):929-939. PMID 42290527.

A 2026 review of emerging androgenetic alopecia pharmacotherapies places PP405 among the metabolic and follicular activators in development, alongside other compounds. The abstract gives no PP405 trial numbers.

Participants / model
Review of the androgenetic alopecia pipeline
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative review
Funding
not stated in the source

A pipeline description, not a trial report.

Read the original source
Ex vivo human follicles: UK-5099 caused proliferative arrest and stress responses

Cell study

Pye D et al. PLoS One. 2024;19(6):e0303742. PMID 38900734.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells, with a gene signature of disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation. The ISR inhibitor ISRIB reduced the effect.

Participants / model
Human scalp hair follicles in ex vivo organ culture
Treatment
UK-5099 added to the culture medium
Follow-up
Short-term culture
Study design
Primary ex vivo study
Funding
not stated in the source

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells.

Read the original source

How does PP405 work, and is it absorbed?

The hypothesis is that inhibiting the mitochondrial pyruvate carrier raises lactate and activates follicle stem cells, shown in mice and cells. It is not established in people, and the registry reports plasma PP405 of 0 ng/mL without posting the assay detection limit.

The chain of reasoning comes from one lab's mouse work and a medicinal chemistry paper: follicle stem cells make lactate, raising lactate speeds their activation in mice, and compounds that inhibit the mitochondrial pyruvate carrier (MPC) do so. The PP405 structure matches the JXL069 analogue with MPC inhibition activity in cells. The human follicle study of the MPC inhibitor UK-5099 points the other way, so MPC inhibition is a hypothesis in humans.

In the phase 2a registry, plasma PP405 was 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted, so the registry entry does not establish that there is no absorption. The company said no systemic absorption was detected in blood. No half-life or Tmax is given in the sources reviewed.

Mouse study: raising lactate activated hair follicle stem cells and the hair cycle

Animal study

Flores A et al. Nat Cell Biol. 2017;19(9):1017-1026. PMID 28812580.

In mice, hair follicle stem cells use glycolysis and make more lactate than other epidermal cells. Deleting lactate dehydrogenase (Ldha) prevented their activation, and deleting the mitochondrial pyruvate carrier 1 (Mpc1) to raise lactate speeded stem cell activation and the hair cycle. The authors also identified small molecules that raise lactate by stimulating Myc or by inhibiting Mpc1 carrier activity and that induced the hair cycle when applied to the skin.

Participants / model
Mice
Treatment
Genetic deletion, and small molecules applied to the skin
Follow-up
not stated in the source
Study design
Primary mechanistic study in mice
Funding
not stated in the source

This is mouse work, not human. The paper discloses patent filings by the University of California and a license to Carthronix LLC, in which one author holds a shareholding and advisory role.

Read the original source
2021 chemistry paper: JXL069, a 7-azaindole, inhibited MPC; analogues regrew hair on shaved mice

Animal study

Liu X et al. J Med Chem. 2021;64(4):2046-2063. PMID 33534563.

A 2021 medicinal chemistry paper from the same UCLA group reports analogues of the MPC inhibitor UK-5099 (JXL001). Inhibitors with a 3,5-bis(trifluoromethyl)benzyl group at the N1 position raised cellular lactate production much more than JXL001, and JXL069, a 7-azaindole, showed significant MPC inhibition activity. More than 10 analogues, not named in the abstract, promoted hair growth on shaved mice after topical treatment.

Participants / model
Cell assays and shaved mice
Treatment
Topical small molecules in mice
Follow-up
not stated in the source
Study design
Primary medicinal chemistry paper (cell and animal)
Funding
not stated in the source

This ties the PP405 structure to MPC inhibition in cells and mice. It is not human data.

Read the original source
Ex vivo human follicles: UK-5099 caused proliferative arrest and stress responses

Cell study

Pye D et al. PLoS One. 2024;19(6):e0303742. PMID 38900734.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells, with a gene signature of disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation. The ISR inhibitor ISRIB reduced the effect.

Participants / model
Human scalp hair follicles in ex vivo organ culture
Treatment
UK-5099 added to the culture medium
Follow-up
Short-term culture
Study design
Primary ex vivo study
Funding
not stated in the source

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells.

Read the original source
Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Company statement, 17 June 2025: exploratory subgroup, 31% versus 0% with a density increase over 20%

Regulatory record

Pelage Pharmaceuticals. Press release published 17 June 2025 announcing phase 2a clinical trial results for PP405 (BioSpace copy of the BusinessWire release).

The company reported that the same 78-person study met its safety and pharmacokinetic endpoints, with no systemic absorption detected in blood. It described hair density as an exploratory endpoint and said that at week 8, 31% of PP405-treated men with a higher degree of hair loss had an increase in hair density of more than 20%, versus 0% on placebo. The release gives no number of men in that subgroup, no hair count result and no p value, and the registered outcomes do not include hair density. The company said it expected to start phase 3 studies in 2026.

Participants / model
Subgroup of men with a higher degree of hair loss in the 78-person phase 2a study
Treatment
Topical PP405, once daily for 4 weeks, follow-up to 12 weeks
Follow-up
Follow-up to 12 weeks; the subgroup result is at week 8
Study design
Company press release (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own statement of an exploratory subgroup result, with no denominators.

Read the original source

What risks and side effects were posted?

In the phase 2a registry results, at least one adverse event occurred in 22 of 51 on PP405 and 10 of 27 on vehicle, with a serious adverse event in 0 of 51 and 1 of 27. Application site itching and redness were the most listed events, and long-term safety is unknown.

The phase 2a registry posted at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none.

The randomized dosing lasted 28 days, with an 84-day open-label extension in 20 participants, so long-term safety is unknown. The phase 2a registration allows all sexes, while the phase 2/3 registration is men only, so information in women is limited to the phase 2a safety study. These are registry statements, and no peer-reviewed safety report was found.

Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Phase 2/3, 600 men estimated: recruiting since 21 September 2026, no results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT07819435.

A phase 2/3 efficacy and long-term safety study is registered and recruiting (Pelage, first posted on 15 September 2026, start 21 September 2026, 600 estimated): men aged 18 to 55 in the United States and Canada randomized 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24, and a 52-week design with re-randomization of the vehicle group. No results exist.

Participants / model
600 men with androgenetic alopecia aged 18 to 55 (estimated, recruiting), in the United States and Canada
Treatment
Topical PP405 0.05% gel versus vehicle, randomized 1:1
Follow-up
52 weeks planned; primary outcome at week 24
Study design
Phase 2/3 randomized vehicle-controlled study, recruiting, no results
Funding
not stated in the source

A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

Read the original source
Searches, 10 October 2026: no FDA record or label, 2 PubMed records, no peer-reviewed human trial

PubMed search record

openFDA Drugs@FDA and DailyMed searches for PP405, suvomipic and JXL069, a PubMed search PP405[tiab] OR JXL069[tiab] OR suvomipic[tiab] OR "PP-405"[tiab] (2 records), and a ClinicalTrials.gov search for PP405 (2 records), all run on 10 October 2026.

openFDA Drugs@FDA returned no record and DailyMed returned no label for PP405, suvomipic or JXL069. The PubMed search returned 2 records: the 2021 medicinal chemistry paper and the 2026 review. No peer-reviewed report of a human trial of PP405 was found. ClinicalTrials.gov returned 2 PP405 records (the phase 2a and the phase 2/3). The registry text refers to an earlier phase 1 trial, PP405-001, and no registration for it was found.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature, registry and FDA record search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Why does PP405 sit in C tier?

C fits a coherent chain of mouse and cell work, a completed phase 2a with posted safety, and a phase 2/3 now recruiting. There is no published human efficacy result, and the one human follicle study of an MPC inhibitor found proliferative arrest.

The mechanism has a coherent chain of primary sources in mice, the compound has a registered, completed phase 2a with posted safety and plasma drug of 0 ng/mL, and a phase 2/3 is recruiting. But no published human efficacy result exists, the only human hair figure is an exploratory subgroup statement in a company press release, and the developer's mouse work is the main support.

The one human follicle study of an MPC inhibitor (UK-5099, ex vivo) found proliferative arrest instead of activation. The claim that PP405 is the most mechanistically novel compound is a ranking opinion that no source tests.

Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Phase 2/3, 600 men estimated: recruiting since 21 September 2026, no results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT07819435.

A phase 2/3 efficacy and long-term safety study is registered and recruiting (Pelage, first posted on 15 September 2026, start 21 September 2026, 600 estimated): men aged 18 to 55 in the United States and Canada randomized 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24, and a 52-week design with re-randomization of the vehicle group. No results exist.

Participants / model
600 men with androgenetic alopecia aged 18 to 55 (estimated, recruiting), in the United States and Canada
Treatment
Topical PP405 0.05% gel versus vehicle, randomized 1:1
Follow-up
52 weeks planned; primary outcome at week 24
Study design
Phase 2/3 randomized vehicle-controlled study, recruiting, no results
Funding
not stated in the source

A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

Read the original source
Company statement, 17 June 2025: exploratory subgroup, 31% versus 0% with a density increase over 20%

Regulatory record

Pelage Pharmaceuticals. Press release published 17 June 2025 announcing phase 2a clinical trial results for PP405 (BioSpace copy of the BusinessWire release).

The company reported that the same 78-person study met its safety and pharmacokinetic endpoints, with no systemic absorption detected in blood. It described hair density as an exploratory endpoint and said that at week 8, 31% of PP405-treated men with a higher degree of hair loss had an increase in hair density of more than 20%, versus 0% on placebo. The release gives no number of men in that subgroup, no hair count result and no p value, and the registered outcomes do not include hair density. The company said it expected to start phase 3 studies in 2026.

Participants / model
Subgroup of men with a higher degree of hair loss in the 78-person phase 2a study
Treatment
Topical PP405, once daily for 4 weeks, follow-up to 12 weeks
Follow-up
Follow-up to 12 weeks; the subgroup result is at week 8
Study design
Company press release (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own statement of an exploratory subgroup result, with no denominators.

Read the original source
Ex vivo human follicles: UK-5099 caused proliferative arrest and stress responses

Cell study

Pye D et al. PLoS One. 2024;19(6):e0303742. PMID 38900734.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells, with a gene signature of disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation. The ISR inhibitor ISRIB reduced the effect.

Participants / model
Human scalp hair follicles in ex vivo organ culture
Treatment
UK-5099 added to the culture medium
Follow-up
Short-term culture
Study design
Primary ex vivo study
Funding
not stated in the source

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells.

Read the original source
Mouse study: raising lactate activated hair follicle stem cells and the hair cycle

Animal study

Flores A et al. Nat Cell Biol. 2017;19(9):1017-1026. PMID 28812580.

In mice, hair follicle stem cells use glycolysis and make more lactate than other epidermal cells. Deleting lactate dehydrogenase (Ldha) prevented their activation, and deleting the mitochondrial pyruvate carrier 1 (Mpc1) to raise lactate speeded stem cell activation and the hair cycle. The authors also identified small molecules that raise lactate by stimulating Myc or by inhibiting Mpc1 carrier activity and that induced the hair cycle when applied to the skin.

Participants / model
Mice
Treatment
Genetic deletion, and small molecules applied to the skin
Follow-up
not stated in the source
Study design
Primary mechanistic study in mice
Funding
not stated in the source

This is mouse work, not human. The paper discloses patent filings by the University of California and a license to Carthronix LLC, in which one author holds a shareholding and advisory role.

Read the original source

Studies and sources

PubChem: PP405 identity, synonyms and structure

Chemical identity record

National Library of Medicine. PubChem compound record CID 137374808 (PP405).

PP405 resolves in PubChem to CID 137374808, C20H11F6N3O2, 439.3 g/mol, CAS 2260696-63-5, IUPAC name (E)-3-[1-[[3,5-bis(trifluoromethyl)phenyl]methyl]pyrrolo[2,3-b]pyridin-3-yl]-2-cyanoprop-2-enoic acid. PubChem lists PP405, PP-405, JXL069, JXL-069 and suvomipic as synonyms of the same record. The structure is a cyanoacrylic acid on a 7-azaindole with a 3,5-bis(trifluoromethyl)benzyl group, which matches the JXL069 analogue described in a 2021 medicinal chemistry paper. The registered trials use PP405 as a 0.05% topical gel.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Mouse study: raising lactate activated hair follicle stem cells and the hair cycle

Animal study

Flores A et al. Nat Cell Biol. 2017;19(9):1017-1026. PMID 28812580.

In mice, hair follicle stem cells use glycolysis and make more lactate than other epidermal cells. Deleting lactate dehydrogenase (Ldha) prevented their activation, and deleting the mitochondrial pyruvate carrier 1 (Mpc1) to raise lactate speeded stem cell activation and the hair cycle. The authors also identified small molecules that raise lactate by stimulating Myc or by inhibiting Mpc1 carrier activity and that induced the hair cycle when applied to the skin.

Participants / model
Mice
Treatment
Genetic deletion, and small molecules applied to the skin
Follow-up
not stated in the source
Study design
Primary mechanistic study in mice
Funding
not stated in the source

This is mouse work, not human. The paper discloses patent filings by the University of California and a license to Carthronix LLC, in which one author holds a shareholding and advisory role.

Read the original source
2021 chemistry paper: JXL069, a 7-azaindole, inhibited MPC; analogues regrew hair on shaved mice

Animal study

Liu X et al. J Med Chem. 2021;64(4):2046-2063. PMID 33534563.

A 2021 medicinal chemistry paper from the same UCLA group reports analogues of the MPC inhibitor UK-5099 (JXL001). Inhibitors with a 3,5-bis(trifluoromethyl)benzyl group at the N1 position raised cellular lactate production much more than JXL001, and JXL069, a 7-azaindole, showed significant MPC inhibition activity. More than 10 analogues, not named in the abstract, promoted hair growth on shaved mice after topical treatment.

Participants / model
Cell assays and shaved mice
Treatment
Topical small molecules in mice
Follow-up
not stated in the source
Study design
Primary medicinal chemistry paper (cell and animal)
Funding
not stated in the source

This ties the PP405 structure to MPC inhibition in cells and mice. It is not human data.

Read the original source
Mouse alopecia models: normal follicles in 30 to 40 days, developer-affiliated author

Animal study

Flores A et al. Exp Dermatol. 2021;30(4):448-456. PMID 33739490.

In mouse alopecia models (aging, repeated chemotherapy, stress), inhibiting pyruvate transport into mitochondria accelerated the hair cycle, with histologically normal follicles within 30 to 40 days and no overt toxicity.

Participants / model
Mice (aging, chemotherapy and stress alopecia models)
Treatment
Pyruvate transport inhibition (route not stated in the abstract)
Follow-up
30 to 40 days
Study design
Primary animal study, developer-affiliated
Funding
not stated in the source

One author is affiliated with Pelage Pharmaceuticals. This is animal work from the developer's group, and the route is not stated in the abstract.

Read the original source
Ex vivo human follicles: UK-5099 caused proliferative arrest and stress responses

Cell study

Pye D et al. PLoS One. 2024;19(6):e0303742. PMID 38900734.

In short-term ex vivo organ culture of human scalp hair follicles, the MPC inhibitor UK-5099 induced a metabolic stress response and proliferative arrest throughout the follicle epithelium, including keratin 15 positive stem cells, with a gene signature of disrupted FGF, IGF, TGF beta and WNT signaling, mitochondrial dysfunction and integrated stress response activation. The ISR inhibitor ISRIB reduced the effect.

Participants / model
Human scalp hair follicles in ex vivo organ culture
Treatment
UK-5099 added to the culture medium
Follow-up
Short-term culture
Study design
Primary ex vivo study
Funding
not stated in the source

This tested UK-5099, not PP405, in cultured follicles for a short time, and it does not match the mouse result that MPC inhibition activates stem cells.

Read the original source
Phase 2a, 78 adults: adverse events 22 of 51 on PP405 and 10 of 27 on vehicle, plasma PP405 0 ng/mL

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT06393452.

Phase 2a safety study, registered and completed (Pelage Pharmaceuticals, results first posted on 22 September 2026): 78 adults aged 18 to 55 with androgenetic alopecia, 51 randomized to PP405 0.05% gel once daily for 28 days with follow-up to day 84 and 27 to vehicle; 20 vehicle participants then took PP405 in an open-label extension for 84 days. Posted safety: at least one adverse event in 22 of 51 on PP405 and 10 of 27 on vehicle, and 8 of 20 in the extension, with a serious adverse event in 0 of 51 and 1 of 27. The most listed events were application site pruritus (7, 2 and 2) and erythema (4, 3 and 3) across the three groups. Investigator and subject skin tolerability scores were nearly all none. The registry reports plasma PP405 of 0 ng/mL at 2 hours after the dose on days 1, 14 and 28 (51 participants) and through day 84 of the extension (20 participants). The detection limit is not posted. The registered outcomes are safety and pharmacokinetics only, with no efficacy outcome.

Participants / model
78 adults with androgenetic alopecia (the registry allows all sexes), plus 20 in the extension
Treatment
Topical PP405 0.05% gel once daily for 28 days (randomized) and 84 days (extension), versus vehicle
Follow-up
28 days randomized with follow-up to day 84; 84-day open-label extension
Study design
Phase 2a randomized vehicle-controlled safety study, registry-posted results
Funding
not stated in the source

Safety and plasma concentration are the registered outcomes. There is no efficacy outcome, and the assay detection limit is not posted.

Read the original source
Company statement, 17 June 2025: exploratory subgroup, 31% versus 0% with a density increase over 20%

Regulatory record

Pelage Pharmaceuticals. Press release published 17 June 2025 announcing phase 2a clinical trial results for PP405 (BioSpace copy of the BusinessWire release).

The company reported that the same 78-person study met its safety and pharmacokinetic endpoints, with no systemic absorption detected in blood. It described hair density as an exploratory endpoint and said that at week 8, 31% of PP405-treated men with a higher degree of hair loss had an increase in hair density of more than 20%, versus 0% on placebo. The release gives no number of men in that subgroup, no hair count result and no p value, and the registered outcomes do not include hair density. The company said it expected to start phase 3 studies in 2026.

Participants / model
Subgroup of men with a higher degree of hair loss in the 78-person phase 2a study
Treatment
Topical PP405, once daily for 4 weeks, follow-up to 12 weeks
Follow-up
Follow-up to 12 weeks; the subgroup result is at week 8
Study design
Company press release (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own statement of an exploratory subgroup result, with no denominators.

Read the original source
Phase 2/3, 600 men estimated: recruiting since 21 September 2026, no results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT07819435.

A phase 2/3 efficacy and long-term safety study is registered and recruiting (Pelage, first posted on 15 September 2026, start 21 September 2026, 600 estimated): men aged 18 to 55 in the United States and Canada randomized 1:1 to PP405 0.05% gel or vehicle, with a primary outcome of change from baseline in non-vellus target area hair count at week 24, and a 52-week design with re-randomization of the vehicle group. No results exist.

Participants / model
600 men with androgenetic alopecia aged 18 to 55 (estimated, recruiting), in the United States and Canada
Treatment
Topical PP405 0.05% gel versus vehicle, randomized 1:1
Follow-up
52 weeks planned; primary outcome at week 24
Study design
Phase 2/3 randomized vehicle-controlled study, recruiting, no results
Funding
not stated in the source

A registration is not evidence of efficacy, and as of this record there is no completed efficacy trial.

Read the original source
2026 review: PP405 among the metabolic and follicular activators in development

Human study

Agrawal A et al. Expert Opin Pharmacother. 2026;27(10):929-939. PMID 42290527.

A 2026 review of emerging androgenetic alopecia pharmacotherapies places PP405 among the metabolic and follicular activators in development, alongside other compounds. The abstract gives no PP405 trial numbers.

Participants / model
Review of the androgenetic alopecia pipeline
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative review
Funding
not stated in the source

A pipeline description, not a trial report.

Read the original source

Why is PP405 in C tier?

C fits a coherent chain of mouse and cell work, a completed phase 2a with posted safety and no detectable plasma drug in the registry, and a phase 2/3 now recruiting. There is no published human efficacy result, the only human hair figure is an exploratory subgroup statement in a company press release, and the one human follicle study of an MPC inhibitor found proliferative arrest instead of activation.