Mirodenafil

updated

Mirodenafil is a PDE5 inhibitor approved in South Korea since 2007 as a prescription erectile dysfunction drug (Mvix), with placebo-controlled trials in Korean men and a 12,055-man post-marketing survey. No US approval was found on 9 October 2026. The supplier line that it was studied for everything except erectile dysfunction does not match the record: erectile dysfunction is the use with the most human trials and the only approved one, and the Alzheimer's phase 2 trial missed its primary endpoints.

Phosphodiesterase-5 inhibitor

  • South Korea's MFDS lists Mvix Tablet 50 mg as a prescription new drug approved on 18 July 2007, with orally disintegrating films approved on 1 December 2011 and 30 November 2012.
  • In a 12-week trial in 223 Korean men with erectile dysfunction, on-demand mirodenafil improved IIEF questions 3 and 4 more than placebo.
  • A meta-analysis of three placebo-controlled trials (374 men) found an IIEF erectile function domain difference of 8.13 (95% CI 6.64 to 9.61) with 100 mg versus placebo.
  • A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24%, most often flushing (0.83%) and headache (0.27%).
  • PubMed searches on 9 October 2026 returned 67 records, 47 with erectile terms; of 8 randomized trial records, 4 were in men with ED.
  • The 210-adult Alzheimer's phase 2 trial of AR1001 (mirodenafil) showed no difference on its co-primary endpoints, and the phase 3 has no posted results.

What is mirodenafil approved to do?

South Korea's MFDS approved Mvix (mirodenafil) tablets on 18 July 2007 as a prescription drug for erectile dysfunction. No US approval was found on 9 October 2026.

South Korea's Ministry of Food and Drug Safety lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007 (item 200708298, license status listed as normal). It also lists Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction, and the latest entry in the label change history is 7 April 2016.

On 9 October 2026, openFDA Drugs@FDA queries for mirodenafil by brand or generic name and by active ingredient returned no matching application. That supports only a dated, US-scoped statement that no US approval was found.

Mirodenafil free base is C26H37N5O5S (531.7 g/mol, CAS 862189-95-5, code SK-3530). The dihydrochloride, listed with the synonyms Mvix and SK 3530, is C26H39Cl2N5O5S (604.6 g/mol, CAS 862189-96-6). MFDS lists the tablet ingredient as mirodenafil hydrochloride and the films as mirodenafil. AR1001 is AriBio's code for mirodenafil in its Alzheimer's program. Vendor material may be base or salt, so mass per dose is not interchangeable.

Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source
FDA record search, 9 October 2026: no matching application

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA API queries run on 9 October 2026 for mirodenafil by brand or generic name and by active ingredient.

The queries for mirodenafil by brand or generic name and by active ingredient returned no matching application. No US approval was found. This supports only a dated, US-scoped statement.

Participants / model
FDA application database, not a clinical population
Treatment
Exact name and ingredient searches
Follow-up
Queries run on 9 October 2026
Study design
Dated US approval-record search
Funding
not stated in the source

A search result shows what the database returned on that date. It is not a worldwide status claim.

Read the original source
PubChem CID 135497803: C26H37N5O5S, 531.7 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 135497803, mirodenafil, with the dihydrochloride CID 135564928.

Mirodenafil free base: PubChem CID 135497803, C26H37N5O5S, 531.7 g/mol, CAS 862189-95-5 (code SK-3530). The dihydrochloride, listed with the synonyms Mvix and SK 3530, is CID 135564928, C26H39Cl2N5O5S, 604.6 g/mol, CAS 862189-96-6. MFDS lists the tablet ingredient as mirodenafil hydrochloride and the films as mirodenafil. AR1001 is AriBio's code for mirodenafil in the Alzheimer's program. Vendor material may be base or salt, so mass per dose is not interchangeable.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule and salt
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

What did the erectile dysfunction trials find?

Mirodenafil improved erectile function over placebo in randomized trials in Korean men: a 223-man trial, a three-trial analysis of 374 men, and a 180-man daily-dosing trial. Most adverse events were mild, and flushing and headache were the most common.

In a 12-week randomized double-blind trial in 223 Korean men with erectile dysfunction of various causes and severities, on-demand mirodenafil 50 or 100 mg improved IIEF questions 3 and 4 more than placebo (Q3 P = 0.0001 and P < 0.0001; Q4 both P < 0.0001). All five IIEF domains, SEP2, SEP3 and the global assessment question improved as well, and most adverse events were mild.

A meta-analysis of three 12-week placebo-controlled trials (374 men) found a higher IIEF erectile function domain score with 100 mg than with placebo (MD 8.13, 95% CI 6.64 to 9.61) and a larger change from baseline (MD 7.32, 95% CI 5.56 to 9.07). Flushing occurred in 15.8% versus 3.2% and headache in 3.1% versus 0%. The three pooled trials are not named in the abstract.

In 180 men with erectile dysfunction randomized to mirodenafil 50 mg once daily or placebo for 12 weeks (71 and 63 completed), IIEF-5 and the International Prostate Symptom Score improved on mirodenafil (P < 0.001 for both). Facial flushing was the most common adverse effect, followed by headache, and cardiovascular measures did not differ.

In an 8-week phase IV trial in 129 Korean men, on-demand orally disintegrating film raised IIEF-5 in all groups, but only the 100 mg film differed significantly from placebo. The 50 mg film did not, and the SEP2 increase was not significant. The trials come from Korean centers, and none was reviewed by FDA or EMA.

Korean 12-week trial: 223 men, IIEF questions 3 and 4 improved over placebo

Randomized controlled trial

Paick JS et al. J Sex Med. 2008;5(11):2672-80. PMID 18638004.

On-demand mirodenafil 50 or 100 mg improved IIEF questions 3 and 4 more than placebo (Q3 P = 0.0001 and P < 0.0001; Q4 both P < 0.0001), along with all five IIEF domains, SEP2, SEP3 and the global assessment question. Most adverse events were mild.

Participants / model
223 Korean men with erectile dysfunction of various causes and severities
Treatment
Oral mirodenafil 50 or 100 mg as needed, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Endpoints were IIEF questions 3 and 4, IIEF domains, SEP2, SEP3, the global assessment question and adverse events.

Read the original source
Meta-analysis: 3 trials, 374 men, IIEF erectile function domain MD 8.13

Systematic review and meta-analysis

Du W et al. Aging Male. 2014;17(2):107-11. PMID 24219508.

The meta-analysis found a higher IIEF erectile function domain score with 100 mg than with placebo (MD 8.13, 95% CI 6.64 to 9.61) and a larger change from baseline (MD 7.32, 95% CI 5.56 to 9.07). Flushing occurred in 15.8% versus 3.2% and headache in 3.1% versus 0%.

Participants / model
374 men with erectile dysfunction in three randomized trials
Treatment
Oral mirodenafil 100 mg versus placebo
Follow-up
Three 12-week placebo-controlled trials
Study design
Meta-analysis of randomized trials
Funding
not stated in the source

The three pooled trials are not named in the abstract.

Read the original source
Daily-dosing trial: 180 men, IIEF-5 and prostate symptom score improved

Randomized controlled trial

Chung JH et al. J Urol. 2013;189(3):1006-13. PMID 23017527.

IIEF-5 and the International Prostate Symptom Score improved on mirodenafil (P < 0.001 for both). Facial flushing was the most common adverse effect, followed by headache, and cardiovascular measures did not differ.

Participants / model
180 men with erectile dysfunction (71 and 63 completed)
Treatment
Oral mirodenafil 50 mg once daily or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were IIEF-5, I-PSS, urinary flow, blood pressure and heart rate.

Read the original source
Film trial: 129 men, only the 100 mg film beat placebo on IIEF-5

Randomized controlled trial

Lee SW et al. World J Mens Health. 2022;40(2):280-289. PMID 33987996.

On-demand orally disintegrating film raised IIEF-5 in all groups, but only the 100 mg film differed significantly from placebo; the 50 mg film did not, and the SEP2 increase was not significant. Most adverse events were mild.

Participants / model
129 Korean men with erectile dysfunction
Treatment
Mirodenafil orally disintegrating film 50 or 100 mg as needed, or placebo
Follow-up
8 weeks
Study design
Phase IV randomized double-blind trial
Funding
not stated in the source

Endpoints were IIEF-5, SEP2, SEP3, the global assessment question and LSC.

Read the original source

Was mirodenafil studied for everything except erectile dysfunction?

No. Erectile dysfunction is the use with the most human trials and the only approved one. PubMed searches on 9 October 2026 returned 67 records, 47 of them with erectile terms, and of 8 records tagged as randomized trials, 4 were in men with ED.

The supplier framing is that mirodenafil, a PDE5 inhibitor, has been studied for everything except erectile dysfunction, the use it was built for. The record does not match that.

PubMed searches run on 9 October 2026 returned 67 records for mirodenafil, 47 for mirodenafil AND erectile, and 20 for mirodenafil NOT erectile. Of the 8 records tagged as randomized controlled trials, 4 were in men with ED, 2 were hemodynamic or pharmacokinetic studies in healthy men, 1 was in premature ejaculation, and 1 was the Alzheimer's phase 2 trial.

The Korean label states that the drug is not an aphrodisiac or stamina enhancer. The uses outside erectile dysfunction are small men's-health trials, one Alzheimer's phase 2 trial that missed its endpoints, a phase 3 still without posted results, and animal work, covered below.

PubMed searches, 9 October 2026: 67 records, 47 with erectile terms, 8 randomized trials

PubMed search record

PubMed searches run on 9 October 2026 for mirodenafil (67 records), mirodenafil AND erectile (47 records), mirodenafil NOT erectile (20 records), and mirodenafil with the randomized controlled trial publication type (8 records).

The searches returned 67 records for mirodenafil, 47 for mirodenafil AND erectile, and 20 for mirodenafil NOT erectile. Of the 8 records tagged as randomized controlled trials, 4 were in men with ED, 2 were hemodynamic or pharmacokinetic studies in healthy men, 1 was in premature ejaculation, and 1 was the Alzheimer's phase 2 trial. ED is the use with the most human trials, and the only approved one.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 9 October 2026
Study design
Literature search
Funding
not stated in the source

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

Read the original source
Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source

What happened in the Alzheimer's trials?

In a 210-adult phase 2 trial, AR1001 (mirodenafil) showed no difference from placebo on the co-primary endpoints. A phase 3 trial, POLARIS-AD, lists 1535 participants and has no posted results.

As AR1001, mirodenafil was tested in a 26-week randomized double-blind phase 2 trial at 21 US sites in 210 adults aged 55 to 80 with mild-to-moderate Alzheimer's disease (MMSE 16 to 26), at 10 or 30 mg once daily versus placebo; 82% completed. There were no differences in the co-primary endpoints (ADAS-Cog13 and ADCS-CGIC) or in secondary efficacy endpoints. Plasma pTau-181, pTau-217 and GFAP improved on 30 mg, and both doses were well tolerated. The paper's full text identifies AR1001 as mirodenafil (Mvix). The sponsor is AriBio, and the trial is registered as NCT03625622.

POLARIS-AD (NCT05531526) is a registered phase 3 trial of AR1001 30 mg once daily versus placebo for 52 weeks in early Alzheimer's disease, with change in CDR-SB as the primary outcome. The registry lists 1535 participants, status active, not recruiting, a primary completion of May 2026, and no posted results. That shows the trial exists, not that it worked.

Company-authored preclinical work (AriBio) reported that mirodenafil improved water-maze and passive-avoidance performance and lowered amyloid-beta and phosphorylated tau in APP-C105 Alzheimer's model mice, with pathway effects in cultured neuronal cells. The mouse route and dose are not stated in the abstract. A second AriBio study reported better sensorimotor and cognitive recovery after experimental stroke in rats given 0.5 to 2 mg/kg/day subcutaneously, with no change in infarct volume. These are animal and cell results.

Alzheimer's phase 2: 210 adults, no difference in co-primary endpoints

Randomized controlled trial

Greeley D et al. J Prev Alzheimers Dis. 2025;12(9):100337. PMID 40912996.

There were no differences in the co-primary endpoints (ADAS-Cog13 and ADCS-CGIC) or in secondary efficacy endpoints. Plasma pTau-181, pTau-217 and GFAP improved on 30 mg, and both doses were well tolerated. The paper's full text identifies AR1001 as mirodenafil (Mvix).

Participants / model
210 adults aged 55 to 80 with mild-to-moderate Alzheimer's disease (MMSE 16 to 26), 82% completed
Treatment
Oral AR1001 (mirodenafil) 10 or 30 mg once daily versus placebo
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2 trial at 21 US sites
Funding
Sponsor AriBio

Endpoints were ADAS-Cog13, ADCS-CGIC, plasma biomarkers and safety.

Read the original source
POLARIS-AD phase 3: 1,535 participants listed, no posted results

Trial registry record

ClinicalTrials.gov record NCT05531526 (POLARIS-AD). Sponsor AriBio.

The registry lists a phase 3 trial (POLARIS-AD) of AR1001 30 mg once daily versus placebo for 52 weeks in early Alzheimer's disease, with change in CDR-SB as the primary outcome, 1535 participants, and status active, not recruiting. The record lists a primary completion of May 2026. No results are posted.

Participants / model
Adults with early Alzheimer's disease
Treatment
Oral AR1001 30 mg once daily versus placebo
Follow-up
52 weeks
Study design
Registered phase 3 randomized trial; no posted results
Funding
Sponsor AriBio

This shows the trial exists, not that it worked. Registered primary outcome CDR-SB at 52 weeks; no posted results.

Read the original source
AriBio preclinical work: APP-C105 mice, neuronal cells, rats after stroke

Animal study

Kang BW et al. Alzheimers Res Ther. 2022;14(1):92. PMID 35804462.

Company-authored preclinical work (AriBio) reported that mirodenafil improved water-maze and passive-avoidance performance and lowered amyloid-beta and phosphorylated tau in APP-C105 Alzheimer's model mice, with pathway effects in cultured neuronal cells. A second AriBio study reported better sensorimotor and cognitive recovery after experimental stroke in rats given 0.5 to 2 mg/kg/day subcutaneously, with no change in infarct volume.

Participants / model
APP-C105 mice; SH-SY5Y and HT-22 cells; rats with middle cerebral artery occlusion
Treatment
Mouse route and dose not stated in the abstract; subcutaneous 0.5 to 2 mg/kg/day in rats
Follow-up
not stated in the source
Study design
Original preclinical studies
Funding
Authored by the company AriBio

These are animal and cell results. The mouse route and dose are not stated in the abstract.

Read the original source

What about premature ejaculation and prostatitis?

Both are small randomized trials. Adding mirodenafil to dapoxetine raised ejaculation latency in 118 men with lifelong premature ejaculation, and adding it to levofloxacin improved symptom scores in 88 men with chronic prostatitis or pelvic pain.

In 118 men with lifelong premature ejaculation and no ED, adding mirodenafil 50 mg to on-demand dapoxetine 30 mg for 12 weeks raised geometric mean IELT by 6.1 versus 3.6 minutes on dapoxetine plus placebo (P = 0.026), with similar adverse events.

In 88 men with chronic prostatitis or chronic pelvic pain syndrome, adding mirodenafil 50 mg/day to levofloxacin for 6 weeks improved IPSS (-4.3 versus -1.1) and NIH-CPSI (-7.2 versus -3.2) more than levofloxacin alone. Both are small trials, and neither is a labeled use.

Small men's-health trials: 118 men with premature ejaculation, 88 with prostatitis

Randomized controlled trial

Lee WK et al. J Sex Med. 2013;10(11):2832-41. PMID 23937271.

In 118 men with lifelong premature ejaculation and no ED, adding mirodenafil 50 mg to on-demand dapoxetine 30 mg for 12 weeks raised geometric mean IELT by 6.1 versus 3.6 minutes on dapoxetine plus placebo (P = 0.026), with similar adverse events. In 88 men with chronic prostatitis or chronic pelvic pain syndrome, adding mirodenafil 50 mg/day to levofloxacin for 6 weeks improved IPSS (-4.3 versus -1.1) and NIH-CPSI (-7.2 versus -3.2) more than levofloxacin alone.

Participants / model
118 men with lifelong premature ejaculation; 88 men with chronic prostatitis or chronic pelvic pain syndrome
Treatment
Oral mirodenafil 50 mg with dapoxetine 30 mg on demand; 50 mg/day with levofloxacin
Follow-up
12 weeks (premature ejaculation); 6 weeks (prostatitis)
Study design
Original randomized trials
Funding
not stated in the source

Endpoints were IELT, sexual act time and PEP; IPSS and NIH-CPSI. These are small men's-health trials.

Read the original source

How does mirodenafil work, and what does the body do with it?

Mirodenafil is a PDE5 inhibitor. After a single 50 mg oral dose, the geometric mean terminal half-life was 3.0 hours in 6 healthy volunteers and 2.2 hours in 6 patients with severe renal impairment.

Mirodenafil is a PDE5 inhibitor, and its Korean label carries the nitrate and guanylate cyclase stimulator contraindications that go with that class. The label states the drug is not an aphrodisiac or stamina enhancer.

After a single 50 mg oral dose, the geometric mean terminal half-life was 3.0 h (95% CI 2.1 to 4.4) in 6 healthy volunteers and 2.2 h (1.4 to 3.4) in 6 patients with severe renal impairment, with apparent clearance of 136.1 and 127.2 L/h. AUC was 8% higher and Cmax 38% higher in the renal group. Mirodenafil is metabolized by CYP3A4 to an active N-dehydroxyethyl metabolite, and ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold.

The MFDS label has no pharmacokinetic section, so the half-life rests on one 12-person study.

PK study: 12 men, half-life 3.0 h healthy and 2.2 h in renal impairment

Human study

Noh YH et al. Int J Clin Pharmacol Ther. 2012;50(12):880-8. PMID 23006442.

The geometric mean terminal half-life was 3.0 h (95% CI 2.1 to 4.4) in 6 healthy volunteers and 2.2 h (1.4 to 3.4) in 6 patients with severe renal impairment, with apparent clearance of 136.1 and 127.2 L/h. AUC was 8% higher and Cmax 38% higher in the renal group. Mirodenafil is metabolized by CYP3A4 to an active N-dehydroxyethyl metabolite.

Participants / model
6 healthy Korean male volunteers and 6 with severe renal impairment
Treatment
Single oral mirodenafil 50 mg
Follow-up
Single dose
Study design
Original clinical PK study
Funding
not stated in the source

The half-life rests on this one 12-person study. The metabolite statement cites a separate paper, PMID 20110038, as described in the same record.

Read the original source
Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source

What risks and warnings does the Korean label report?

The Korean label lists contraindications for nitrates and nitric oxide donors, guanylate cyclase stimulators such as riociguat, recent stroke or heart attack, and several other conditions. The most common adverse reactions were flushing (13.5%) and headache (8.2%) in label trials.

The Korean label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat. It also contraindicates use in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience.

In trials of 563 patients, flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives.

Ketoconazole raised mirodenafil AUC about 5-fold. No FDA or EMA safety review exists for mirodenafil, and no US approval was found.

Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source
FDA record search, 9 October 2026: no matching application

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA API queries run on 9 October 2026 for mirodenafil by brand or generic name and by active ingredient.

The queries for mirodenafil by brand or generic name and by active ingredient returned no matching application. No US approval was found. This supports only a dated, US-scoped statement.

Participants / model
FDA application database, not a clinical population
Treatment
Exact name and ingredient searches
Follow-up
Queries run on 9 October 2026
Study design
Dated US approval-record search
Funding
not stated in the source

A search result shows what the database returned on that date. It is not a worldwide status claim.

Read the original source

Why does mirodenafil sit in A tier?

Approval in South Korea since 2007, placebo-controlled trials, a 374-man meta-analysis and a 12,055-man post-marketing survey support the A for erectile dysfunction. The approval is Korea-only and the Alzheimer's phase 2 trial missed its primary endpoints.

The A applies to erectile dysfunction in men, the labeled use. The approval is Korea-only, the erectile dysfunction trials come from Korean centers with no FDA or EMA review, and the Alzheimer's program missed its phase 2 primary endpoints while the phase 3 has no posted results.

The supplier framing is wrong on the record: erectile dysfunction is the most-studied human use, and the other uses are small men's-health trials, one failed Alzheimer's phase 2 trial, a phase 3 still running, and animal work.

Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source
Korean 12-week trial: 223 men, IIEF questions 3 and 4 improved over placebo

Randomized controlled trial

Paick JS et al. J Sex Med. 2008;5(11):2672-80. PMID 18638004.

On-demand mirodenafil 50 or 100 mg improved IIEF questions 3 and 4 more than placebo (Q3 P = 0.0001 and P < 0.0001; Q4 both P < 0.0001), along with all five IIEF domains, SEP2, SEP3 and the global assessment question. Most adverse events were mild.

Participants / model
223 Korean men with erectile dysfunction of various causes and severities
Treatment
Oral mirodenafil 50 or 100 mg as needed, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Endpoints were IIEF questions 3 and 4, IIEF domains, SEP2, SEP3, the global assessment question and adverse events.

Read the original source
Meta-analysis: 3 trials, 374 men, IIEF erectile function domain MD 8.13

Systematic review and meta-analysis

Du W et al. Aging Male. 2014;17(2):107-11. PMID 24219508.

The meta-analysis found a higher IIEF erectile function domain score with 100 mg than with placebo (MD 8.13, 95% CI 6.64 to 9.61) and a larger change from baseline (MD 7.32, 95% CI 5.56 to 9.07). Flushing occurred in 15.8% versus 3.2% and headache in 3.1% versus 0%.

Participants / model
374 men with erectile dysfunction in three randomized trials
Treatment
Oral mirodenafil 100 mg versus placebo
Follow-up
Three 12-week placebo-controlled trials
Study design
Meta-analysis of randomized trials
Funding
not stated in the source

The three pooled trials are not named in the abstract.

Read the original source
Alzheimer's phase 2: 210 adults, no difference in co-primary endpoints

Randomized controlled trial

Greeley D et al. J Prev Alzheimers Dis. 2025;12(9):100337. PMID 40912996.

There were no differences in the co-primary endpoints (ADAS-Cog13 and ADCS-CGIC) or in secondary efficacy endpoints. Plasma pTau-181, pTau-217 and GFAP improved on 30 mg, and both doses were well tolerated. The paper's full text identifies AR1001 as mirodenafil (Mvix).

Participants / model
210 adults aged 55 to 80 with mild-to-moderate Alzheimer's disease (MMSE 16 to 26), 82% completed
Treatment
Oral AR1001 (mirodenafil) 10 or 30 mg once daily versus placebo
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2 trial at 21 US sites
Funding
Sponsor AriBio

Endpoints were ADAS-Cog13, ADCS-CGIC, plasma biomarkers and safety.

Read the original source
POLARIS-AD phase 3: 1,535 participants listed, no posted results

Trial registry record

ClinicalTrials.gov record NCT05531526 (POLARIS-AD). Sponsor AriBio.

The registry lists a phase 3 trial (POLARIS-AD) of AR1001 30 mg once daily versus placebo for 52 weeks in early Alzheimer's disease, with change in CDR-SB as the primary outcome, 1535 participants, and status active, not recruiting. The record lists a primary completion of May 2026. No results are posted.

Participants / model
Adults with early Alzheimer's disease
Treatment
Oral AR1001 30 mg once daily versus placebo
Follow-up
52 weeks
Study design
Registered phase 3 randomized trial; no posted results
Funding
Sponsor AriBio

This shows the trial exists, not that it worked. Registered primary outcome CDR-SB at 52 weeks; no posted results.

Read the original source
PubMed searches, 9 October 2026: 67 records, 47 with erectile terms, 8 randomized trials

PubMed search record

PubMed searches run on 9 October 2026 for mirodenafil (67 records), mirodenafil AND erectile (47 records), mirodenafil NOT erectile (20 records), and mirodenafil with the randomized controlled trial publication type (8 records).

The searches returned 67 records for mirodenafil, 47 for mirodenafil AND erectile, and 20 for mirodenafil NOT erectile. Of the 8 records tagged as randomized controlled trials, 4 were in men with ED, 2 were hemodynamic or pharmacokinetic studies in healthy men, 1 was in premature ejaculation, and 1 was the Alzheimer's phase 2 trial. ED is the use with the most human trials, and the only approved one.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 9 October 2026
Study design
Literature search
Funding
not stated in the source

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

Read the original source

Studies and sources

Korean MFDS record: Mvix tablet approved 18 July 2007, films 2011 and 2012; contraindications and safety data

Official label

Ministry of Food and Drug Safety, Republic of Korea. Drug database record for Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals), item 200708298, with Mvix S orally disintegrating films. The latest label change history entry is 7 April 2016.

MFDS lists Mvix Tablet 50 mg (mirodenafil hydrochloride, SK Chemicals) as a prescription new drug approved on 18 July 2007, with license status listed as normal, plus Mvix S orally disintegrating films of 50 mg (approved 1 December 2011) and 100 mg (30 November 2012). The labeled indication is treatment of erectile dysfunction. The label contraindicates use with nitrates or nitric oxide donors and with guanylate cyclase stimulators such as riociguat, and in men with stroke, transient ischemic attack, myocardial infarction or bypass surgery within 6 months, resting blood pressure below 90/50 or above 170/100 mmHg, uncontrolled arrhythmia, congenital QT prolongation or QT-prolonging drugs, hereditary retinal degeneration, prior NAION, severe hepatic or renal failure, other ED drugs, or age 18 or under. Use at 71 or older is not recommended for lack of clinical experience. In trials (563 patients), flushing occurred in 13.5% on 50 to 100 mg (n = 318) versus 2.8% on placebo (n = 216), and headache in 8.2% versus 0.9%. A 6-year Korean post-marketing survey of 12,055 men found adverse drug reactions in 1.24% (150 men), most often flushing (0.83%) and headache (0.27%). Ketoconazole 400 mg/day raised mirodenafil AUC about 5-fold. The label also summarizes 12-week trials in 112 men with diabetes and 109 men on antihypertensives, and states the drug is not an aphrodisiac or stamina enhancer.

Participants / model
Adult men with erectile dysfunction; healthy volunteers for interaction data
Treatment
Oral tablet 50 mg; orally disintegrating film 50 and 100 mg
Follow-up
Approvals from 2007 to 2012; label change history to 7 April 2016; post-marketing survey of 6 years
Study design
Official regulator record and label (MFDS drug database)
Funding
not stated in the source

The page gives no label dosing or timing. The MFDS label has no pharmacokinetic section, and current marketing of the tablet versus the films is not confirmed.

Read the original source
Korean 12-week trial: 223 men, IIEF questions 3 and 4 improved over placebo

Randomized controlled trial

Paick JS et al. J Sex Med. 2008;5(11):2672-80. PMID 18638004.

On-demand mirodenafil 50 or 100 mg improved IIEF questions 3 and 4 more than placebo (Q3 P = 0.0001 and P < 0.0001; Q4 both P < 0.0001), along with all five IIEF domains, SEP2, SEP3 and the global assessment question. Most adverse events were mild.

Participants / model
223 Korean men with erectile dysfunction of various causes and severities
Treatment
Oral mirodenafil 50 or 100 mg as needed, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Endpoints were IIEF questions 3 and 4, IIEF domains, SEP2, SEP3, the global assessment question and adverse events.

Read the original source
Meta-analysis: 3 trials, 374 men, IIEF erectile function domain MD 8.13

Systematic review and meta-analysis

Du W et al. Aging Male. 2014;17(2):107-11. PMID 24219508.

The meta-analysis found a higher IIEF erectile function domain score with 100 mg than with placebo (MD 8.13, 95% CI 6.64 to 9.61) and a larger change from baseline (MD 7.32, 95% CI 5.56 to 9.07). Flushing occurred in 15.8% versus 3.2% and headache in 3.1% versus 0%.

Participants / model
374 men with erectile dysfunction in three randomized trials
Treatment
Oral mirodenafil 100 mg versus placebo
Follow-up
Three 12-week placebo-controlled trials
Study design
Meta-analysis of randomized trials
Funding
not stated in the source

The three pooled trials are not named in the abstract.

Read the original source
Daily-dosing trial: 180 men, IIEF-5 and prostate symptom score improved

Randomized controlled trial

Chung JH et al. J Urol. 2013;189(3):1006-13. PMID 23017527.

IIEF-5 and the International Prostate Symptom Score improved on mirodenafil (P < 0.001 for both). Facial flushing was the most common adverse effect, followed by headache, and cardiovascular measures did not differ.

Participants / model
180 men with erectile dysfunction (71 and 63 completed)
Treatment
Oral mirodenafil 50 mg once daily or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were IIEF-5, I-PSS, urinary flow, blood pressure and heart rate.

Read the original source
Film trial: 129 men, only the 100 mg film beat placebo on IIEF-5

Randomized controlled trial

Lee SW et al. World J Mens Health. 2022;40(2):280-289. PMID 33987996.

On-demand orally disintegrating film raised IIEF-5 in all groups, but only the 100 mg film differed significantly from placebo; the 50 mg film did not, and the SEP2 increase was not significant. Most adverse events were mild.

Participants / model
129 Korean men with erectile dysfunction
Treatment
Mirodenafil orally disintegrating film 50 or 100 mg as needed, or placebo
Follow-up
8 weeks
Study design
Phase IV randomized double-blind trial
Funding
not stated in the source

Endpoints were IIEF-5, SEP2, SEP3, the global assessment question and LSC.

Read the original source
PK study: 12 men, half-life 3.0 h healthy and 2.2 h in renal impairment

Human study

Noh YH et al. Int J Clin Pharmacol Ther. 2012;50(12):880-8. PMID 23006442.

The geometric mean terminal half-life was 3.0 h (95% CI 2.1 to 4.4) in 6 healthy volunteers and 2.2 h (1.4 to 3.4) in 6 patients with severe renal impairment, with apparent clearance of 136.1 and 127.2 L/h. AUC was 8% higher and Cmax 38% higher in the renal group. Mirodenafil is metabolized by CYP3A4 to an active N-dehydroxyethyl metabolite.

Participants / model
6 healthy Korean male volunteers and 6 with severe renal impairment
Treatment
Single oral mirodenafil 50 mg
Follow-up
Single dose
Study design
Original clinical PK study
Funding
not stated in the source

The half-life rests on this one 12-person study. The metabolite statement cites a separate paper, PMID 20110038, as described in the same record.

Read the original source
Alzheimer's phase 2: 210 adults, no difference in co-primary endpoints

Randomized controlled trial

Greeley D et al. J Prev Alzheimers Dis. 2025;12(9):100337. PMID 40912996.

There were no differences in the co-primary endpoints (ADAS-Cog13 and ADCS-CGIC) or in secondary efficacy endpoints. Plasma pTau-181, pTau-217 and GFAP improved on 30 mg, and both doses were well tolerated. The paper's full text identifies AR1001 as mirodenafil (Mvix).

Participants / model
210 adults aged 55 to 80 with mild-to-moderate Alzheimer's disease (MMSE 16 to 26), 82% completed
Treatment
Oral AR1001 (mirodenafil) 10 or 30 mg once daily versus placebo
Follow-up
26 weeks
Study design
Randomized double-blind placebo-controlled phase 2 trial at 21 US sites
Funding
Sponsor AriBio

Endpoints were ADAS-Cog13, ADCS-CGIC, plasma biomarkers and safety.

Read the original source
POLARIS-AD phase 3: 1,535 participants listed, no posted results

Trial registry record

ClinicalTrials.gov record NCT05531526 (POLARIS-AD). Sponsor AriBio.

The registry lists a phase 3 trial (POLARIS-AD) of AR1001 30 mg once daily versus placebo for 52 weeks in early Alzheimer's disease, with change in CDR-SB as the primary outcome, 1535 participants, and status active, not recruiting. The record lists a primary completion of May 2026. No results are posted.

Participants / model
Adults with early Alzheimer's disease
Treatment
Oral AR1001 30 mg once daily versus placebo
Follow-up
52 weeks
Study design
Registered phase 3 randomized trial; no posted results
Funding
Sponsor AriBio

This shows the trial exists, not that it worked. Registered primary outcome CDR-SB at 52 weeks; no posted results.

Read the original source
AriBio preclinical work: APP-C105 mice, neuronal cells, rats after stroke

Animal study

Kang BW et al. Alzheimers Res Ther. 2022;14(1):92. PMID 35804462.

Company-authored preclinical work (AriBio) reported that mirodenafil improved water-maze and passive-avoidance performance and lowered amyloid-beta and phosphorylated tau in APP-C105 Alzheimer's model mice, with pathway effects in cultured neuronal cells. A second AriBio study reported better sensorimotor and cognitive recovery after experimental stroke in rats given 0.5 to 2 mg/kg/day subcutaneously, with no change in infarct volume.

Participants / model
APP-C105 mice; SH-SY5Y and HT-22 cells; rats with middle cerebral artery occlusion
Treatment
Mouse route and dose not stated in the abstract; subcutaneous 0.5 to 2 mg/kg/day in rats
Follow-up
not stated in the source
Study design
Original preclinical studies
Funding
Authored by the company AriBio

These are animal and cell results. The mouse route and dose are not stated in the abstract.

Read the original source
Small men's-health trials: 118 men with premature ejaculation, 88 with prostatitis

Randomized controlled trial

Lee WK et al. J Sex Med. 2013;10(11):2832-41. PMID 23937271.

In 118 men with lifelong premature ejaculation and no ED, adding mirodenafil 50 mg to on-demand dapoxetine 30 mg for 12 weeks raised geometric mean IELT by 6.1 versus 3.6 minutes on dapoxetine plus placebo (P = 0.026), with similar adverse events. In 88 men with chronic prostatitis or chronic pelvic pain syndrome, adding mirodenafil 50 mg/day to levofloxacin for 6 weeks improved IPSS (-4.3 versus -1.1) and NIH-CPSI (-7.2 versus -3.2) more than levofloxacin alone.

Participants / model
118 men with lifelong premature ejaculation; 88 men with chronic prostatitis or chronic pelvic pain syndrome
Treatment
Oral mirodenafil 50 mg with dapoxetine 30 mg on demand; 50 mg/day with levofloxacin
Follow-up
12 weeks (premature ejaculation); 6 weeks (prostatitis)
Study design
Original randomized trials
Funding
not stated in the source

Endpoints were IELT, sexual act time and PEP; IPSS and NIH-CPSI. These are small men's-health trials.

Read the original source
PubChem CID 135497803: C26H37N5O5S, 531.7 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 135497803, mirodenafil, with the dihydrochloride CID 135564928.

Mirodenafil free base: PubChem CID 135497803, C26H37N5O5S, 531.7 g/mol, CAS 862189-95-5 (code SK-3530). The dihydrochloride, listed with the synonyms Mvix and SK 3530, is CID 135564928, C26H39Cl2N5O5S, 604.6 g/mol, CAS 862189-96-6. MFDS lists the tablet ingredient as mirodenafil hydrochloride and the films as mirodenafil. AR1001 is AriBio's code for mirodenafil in the Alzheimer's program. Vendor material may be base or salt, so mass per dose is not interchangeable.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule and salt
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

Why is Mirodenafil in A tier?

A fits an approved prescription erectile dysfunction drug with placebo-controlled trials, a 374-man meta-analysis and a 12,055-man post-marketing survey behind it. The approval is Korea-only, the trials come from Korean centers with no FDA or EMA review, and the Alzheimer's phase 2 trial missed its primary endpoints. The grade covers erectile dysfunction, the labeled use.