reptides / Bromantane

Bromantane

A small placebo trial found faster and larger improvement in asthenic symptoms with oral Ladasten, and a 728-patient uncontrolled report also described short-term response. Bromantane is a Russian prescription drug for asthenic conditions. A 10-person healthy-volunteer experiment found no improvement in core task performance.

Adamantane-derived small-molecule antiasthenic drug

  • Small molecule, not a peptide
  • Marketed in Russia as Ladasten
  • Listed by WADA as an in-competition stimulant
What is it? Where is it authorized? What did the placebo trial show? What did the 728-person study show? Does it help healthy people? What is known about half-life and safety? Is it prohibited in sport? How might it work?

What substance and product do the studies concern?

Bromantane, also indexed as bromantan or adamantylbromophenylamine, is an adamantane-derived small molecule. The clinical reports concern oral Ladasten tablets, so their findings do not authenticate a bulk chemical or online nootropic product.

The current Russian reference entry describes 50 mg and 100 mg prescription tablets containing adamantylbromophenylamine. Bromantane is not a peptide and has no amino-acid sequence.

Ladasten label reproduction · indication, PK, safety

Current drug-reference and label reproduction

Vidal Russia, updated December 6, 2023; registration metadata dated May 16, 2024

The entry lists prescription 50 mg and 100 mg tablets, Russian registration ЛП-№(005486)-(РГ-RU), asthenic-state and neurasthenia indications, label pharmacokinetic values, contraindications, adverse reactions, and two interaction statements.

  • Reported label values: Cmax 363.3 ng/mL, Tmax 2 to 4 hours, half-life 11.21 hours.
  • No underlying pharmacokinetic study or variability data are cited.
Participants / model
Adults covered by the reproduced Russian Ladasten instruction
Treatment
Oral adamantylbromophenylamine tablets
Record context
Product instruction
Study design
Russian-language drug-reference reproduction of an approved instruction

This secondary reproduction is neither the official GRLS interface nor a primary pharmacokinetic report.

Read the original source

What is Bromantane's current regulatory status?

A Russian drug-reference reproduction lists Ladasten under replacement registration ЛП-№(005486)-(РГ-RU), dated May 16, 2024 with an indefinite term. The older GRLS-derived record is inactive and links to that replacement. This is secondary registration metadata rather than an official GRLS record.

The reproduced Russian indication is treatment of asthenic states of various origins, including after somatic illness or infection, and neurasthenia. It is not a general approval for cognition, motivation, sport, or fatigue in an otherwise healthy person.

FDA Drugs@FDA records contained no exact-name match for bromantane, bromantan, or adamantylbromophenylamine.

Ladasten label reproduction · indication, PK, safety

Current drug-reference and label reproduction

Vidal Russia, updated December 6, 2023; registration metadata dated May 16, 2024

The entry lists prescription 50 mg and 100 mg tablets, Russian registration ЛП-№(005486)-(РГ-RU), asthenic-state and neurasthenia indications, label pharmacokinetic values, contraindications, adverse reactions, and two interaction statements.

  • Reported label values: Cmax 363.3 ng/mL, Tmax 2 to 4 hours, half-life 11.21 hours.
  • No underlying pharmacokinetic study or variability data are cited.
Participants / model
Adults covered by the reproduced Russian Ladasten instruction
Treatment
Oral adamantylbromophenylamine tablets
Record context
Product instruction
Study design
Russian-language drug-reference reproduction of an approved instruction

This secondary reproduction is neither the official GRLS interface nor a primary pharmacokinetic report.

Read the original source
Russian register metadata · replacement link

Secondary regulatory record

Pharm-Portal GRLS reference.

The older ЛСР-010257/08 record is marked inactive and links to replacement registration ЛП-№(005486)-(РГ-RU).

Participants / model
Russian Ladasten registration records
Treatment
Adamantylbromophenylamine
Follow-up
Older record registered December 19, 2008
Study design
Third-party reproduction of state-register metadata

The cited source is a third-party reproduction rather than an official GRLS record.

Read the original source
FDA records · no exact-name match

Regulatory database record set

openFDA Drugs@FDA records

Drugs@FDA records contained no match under bromantane, bromantan, or adamantylbromophenylamine.

Participants / model
FDA drug-application records exposed through openFDA
Treatment
Bromantane name and aliases
Study design
Exact-name U.S. approval coverage
Read the original source

How strong is the controlled evidence in neurasthenia?

The 2009 Russian trial found faster and larger improvement in asthenic symptoms with Ladasten than placebo. It randomized 30 patients with situational asthenic symptoms or neurasthenia, 15 per group, and was described as single-blind. Treatment lasted 28 days, followed by one week on placebo.

Ladasten was started at 100 mg a day in two doses and could be adjusted to 50 to 150 mg a day. The report describes faster and larger improvement in asthenic symptoms with Ladasten, but all 15 active recipients completed while only 7 of 15 placebo recipients did. Eight placebo patients stopped on days 14 to 19 for absent or minimal benefit or worsening, which makes the between-group estimate fragile.

The authors reported no withdrawal syndrome during the one-week placebo phase. That brief observation in a tiny trial does not establish absence of dependence or withdrawal after longer use.

2009 Russian placebo trial · n=30, high placebo attrition

Randomized single-blind placebo-controlled trial

Neznamov et al., Zhurnal Nevrologii i Psikhiatrii, 2009

Asthenic symptoms improved faster and more strongly with Ladasten, but 8 of 15 placebo recipients stopped early for poor effect or worsening while all 15 active recipients completed.

  • No withdrawal syndrome was reported during one week after the 28-day treatment phase.
  • The differential attrition makes the apparent treatment effect hard to estimate reliably.
Participants / model
30 patients with situational asthenic symptoms or neurasthenia, 15 per group
Treatment
Ladasten initially 100 mg/day in two doses, adjustable to 50 to 150 mg/day, versus matched placebo
Follow-up
28 days plus a one-week placebo withdrawal phase
Study design
Russian-language full report of a randomized, single-blind, placebo-controlled trial

Randomization method and allocation concealment were not described in the report, and placebo attrition was severe.

Read the original source

What did the large Russian report find?

The 2011 report described high investigator-rated response and low short-term adverse-event rates among 728 patients treated for 28 days at 28 Russian centers. The indexed abstract does not identify a randomized control group, so time, expectation, and concurrent care could contribute to the results.

The authors reported response rates of 76.0% by CGI-S and 90.8% by CGI-I, adverse events in 3.0%, discontinuation for adverse events in 0.8%, and no serious adverse events. Those are uncontrolled, investigator-rated outcomes from a 28-day product study, not proof of benefit or long-term safety.

2011 multicenter report · uncontrolled n=728

Multicenter observational treatment report

Avedisova et al., Zhurnal Nevrologii i Psikhiatrii, 2011

Among 728 analyzed patients, the report gives CGI-S and CGI-I response rates of 76.0% and 90.8%, adverse events in 3.0%, discontinuation in 0.8%, and no serious adverse events during 28 days.

Participants / model
728 analyzed patients with asthenic disorders and psychoautonomic syndrome across 28 Russian centers
Treatment
Oral Ladasten 50 to 100 mg daily
Follow-up
28 days, with a reported one-month follow-up
Study design
Russian multicenter report; no controlled allocation stated in the indexed abstract

The abstract describes no controlled allocation.

Read the original source

Did Bromantane improve cognition or performance in healthy volunteers?

The healthy-person evidence is a Russian report of 10 untired men after one oral dose compared with placebo. The abstract says bromantane did not change subjective state or the main components of operator performance.

It reported EEG patterns interpreted as increased vigilance and less tremor, then speculated about reserve performance under fatigue or extreme conditions. The experiment did not measure durable attention, memory, motivation, or real-world performance.

2000 Russian healthy-volunteer study · n=10 acute

Small acute placebo comparison

Viatleva et al., Voenno-Meditsinskii Zhurnal, 2000

In 10 healthy untired men after one oral dose, the abstract reports no change in subjective state or principal operator-performance components, with EEG vigilance and tremor differences interpreted as favorable.

Participants / model
10 healthy, untired male volunteers
Treatment
Single oral bromantane exposure versus placebo
Follow-up
Acute laboratory assessment
Study design
Russian-language comparative report with an English abstract

The English abstract omits the dose. The study did not measure durable cognitive or functional benefit.

Read the original source

What does the label report about half-life and safety?

The current Russian label reproduction states a 2-to-4-hour time to peak, a peak concentration of 363.3 ng/mL, and an 11.21-hour half-life. It provides no study citation, sample size, dose, concentration-time table, or variability, so the value rests on the label rather than a primary human pharmacokinetic report.

The reproduced label lists excessive activation, difficulty falling asleep, and allergic reactions. It lists pregnancy, breastfeeding, age under 18, and individual intolerance as contraindications.

Its interaction section says Ladasten reduces the hypnotic effect of sodium thiopental and does not weaken benzodiazepine anxiolysis. The label lists no other interaction data, and the cited human reports do not establish safety with months or years of exposure.

Ladasten label reproduction · indication, PK, safety

Current drug-reference and label reproduction

Vidal Russia, updated December 6, 2023; registration metadata dated May 16, 2024

The entry lists prescription 50 mg and 100 mg tablets, Russian registration ЛП-№(005486)-(РГ-RU), asthenic-state and neurasthenia indications, label pharmacokinetic values, contraindications, adverse reactions, and two interaction statements.

  • Reported label values: Cmax 363.3 ng/mL, Tmax 2 to 4 hours, half-life 11.21 hours.
  • No underlying pharmacokinetic study or variability data are cited.
Participants / model
Adults covered by the reproduced Russian Ladasten instruction
Treatment
Oral adamantylbromophenylamine tablets
Record context
Product instruction
Study design
Russian-language drug-reference reproduction of an approved instruction

This secondary reproduction is neither the official GRLS interface nor a primary pharmacokinetic report.

Read the original source
2011 multicenter report · uncontrolled n=728

Multicenter observational treatment report

Avedisova et al., Zhurnal Nevrologii i Psikhiatrii, 2011

Among 728 analyzed patients, the report gives CGI-S and CGI-I response rates of 76.0% and 90.8%, adverse events in 3.0%, discontinuation in 0.8%, and no serious adverse events during 28 days.

Participants / model
728 analyzed patients with asthenic disorders and psychoautonomic syndrome across 28 Russian centers
Treatment
Oral Ladasten 50 to 100 mg daily
Follow-up
28 days, with a reported one-month follow-up
Study design
Russian multicenter report; no controlled allocation stated in the indexed abstract

The abstract describes no controlled allocation.

Read the original source

Can an athlete use Bromantane under WADA rules?

Bromantan is named in section S6.A of WADA's 2026 Prohibited List as a non-specified stimulant prohibited in competition. A Russian prescription or medical indication does not by itself remove that anti-doping rule.

WADA 2026 · Bromantan prohibited in competition

Official anti-doping standard

World Anti-Doping Agency, effective January 1, 2026

Bromantan appears in S6.A among non-specified stimulants prohibited in competition.

Participants / model
Athletes subject to the World Anti-Doping Code
Treatment
Bromantan exposure
Follow-up
2026 Prohibited List
Study design
Official regulatory standard

Therapeutic-use exemption rules are separate and depend on the applicable anti-doping process.

Read the original source

Does Bromantane work by increasing dopamine synthesis?

That mechanism is supported mainly by preclinical work. A Russian rat study found that 50 mg/kg Ladasten changed tyrosine hydroxylase and DOPA decarboxylase gene expression and was associated with higher L-DOPA and dopamine in parts of the brain.

The experiment involved rat striatum and hypothalamus, not people taking the marketed dose. Human symptom improvement does not prove that this pathway mediates the clinical result.

Rat mechanism study · dopamine-synthesis enzymes

Preclinical mechanism study

Vakhitova et al., Eksperimentalnaia i Klinicheskaia Farmakologiia, 2004

After 50 mg/kg Ladasten in rats, changes in tyrosine hydroxylase and DOPA decarboxylase expression correlated with L-DOPA and dopamine accumulation in striatum and hypothalamus.

Participants / model
Laboratory rats
Treatment
Ladasten 50 mg/kg
Follow-up
Time-course over the first hours after exposure
Study design
Russian preclinical gene-expression and neurochemistry experiment with an English abstract
Funding
Non-U.S. government research support indexed by PubMed

No human experiment in this source tested the mechanism, effect size, or dose relationship.

Read the original source

Studies and sources

Ladasten label reproduction · indication, PK, safety

Current drug-reference and label reproduction

Vidal Russia, updated December 6, 2023; registration metadata dated May 16, 2024

The entry lists prescription 50 mg and 100 mg tablets, Russian registration ЛП-№(005486)-(РГ-RU), asthenic-state and neurasthenia indications, label pharmacokinetic values, contraindications, adverse reactions, and two interaction statements.

  • Reported label values: Cmax 363.3 ng/mL, Tmax 2 to 4 hours, half-life 11.21 hours.
  • No underlying pharmacokinetic study or variability data are cited.
Participants / model
Adults covered by the reproduced Russian Ladasten instruction
Treatment
Oral adamantylbromophenylamine tablets
Record context
Product instruction
Study design
Russian-language drug-reference reproduction of an approved instruction

This secondary reproduction is neither the official GRLS interface nor a primary pharmacokinetic report.

Read the original source
Russian register metadata · replacement link

Secondary regulatory record

Pharm-Portal GRLS reference.

The older ЛСР-010257/08 record is marked inactive and links to replacement registration ЛП-№(005486)-(РГ-RU).

Participants / model
Russian Ladasten registration records
Treatment
Adamantylbromophenylamine
Follow-up
Older record registered December 19, 2008
Study design
Third-party reproduction of state-register metadata

The cited source is a third-party reproduction rather than an official GRLS record.

Read the original source
FDA records · no exact-name match

Regulatory database record set

openFDA Drugs@FDA records

Drugs@FDA records contained no match under bromantane, bromantan, or adamantylbromophenylamine.

Participants / model
FDA drug-application records exposed through openFDA
Treatment
Bromantane name and aliases
Study design
Exact-name U.S. approval coverage
Read the original source
2009 Russian placebo trial · n=30, high placebo attrition

Randomized single-blind placebo-controlled trial

Neznamov et al., Zhurnal Nevrologii i Psikhiatrii, 2009

Asthenic symptoms improved faster and more strongly with Ladasten, but 8 of 15 placebo recipients stopped early for poor effect or worsening while all 15 active recipients completed.

  • No withdrawal syndrome was reported during one week after the 28-day treatment phase.
  • The differential attrition makes the apparent treatment effect hard to estimate reliably.
Participants / model
30 patients with situational asthenic symptoms or neurasthenia, 15 per group
Treatment
Ladasten initially 100 mg/day in two doses, adjustable to 50 to 150 mg/day, versus matched placebo
Follow-up
28 days plus a one-week placebo withdrawal phase
Study design
Russian-language full report of a randomized, single-blind, placebo-controlled trial

Randomization method and allocation concealment were not described in the report, and placebo attrition was severe.

Read the original source
2011 multicenter report · uncontrolled n=728

Multicenter observational treatment report

Avedisova et al., Zhurnal Nevrologii i Psikhiatrii, 2011

Among 728 analyzed patients, the report gives CGI-S and CGI-I response rates of 76.0% and 90.8%, adverse events in 3.0%, discontinuation in 0.8%, and no serious adverse events during 28 days.

Participants / model
728 analyzed patients with asthenic disorders and psychoautonomic syndrome across 28 Russian centers
Treatment
Oral Ladasten 50 to 100 mg daily
Follow-up
28 days, with a reported one-month follow-up
Study design
Russian multicenter report; no controlled allocation stated in the indexed abstract

The abstract describes no controlled allocation.

Read the original source
2000 Russian healthy-volunteer study · n=10 acute

Small acute placebo comparison

Viatleva et al., Voenno-Meditsinskii Zhurnal, 2000

In 10 healthy untired men after one oral dose, the abstract reports no change in subjective state or principal operator-performance components, with EEG vigilance and tremor differences interpreted as favorable.

Participants / model
10 healthy, untired male volunteers
Treatment
Single oral bromantane exposure versus placebo
Follow-up
Acute laboratory assessment
Study design
Russian-language comparative report with an English abstract

The English abstract omits the dose. The study did not measure durable cognitive or functional benefit.

Read the original source
Rat mechanism study · dopamine-synthesis enzymes

Preclinical mechanism study

Vakhitova et al., Eksperimentalnaia i Klinicheskaia Farmakologiia, 2004

After 50 mg/kg Ladasten in rats, changes in tyrosine hydroxylase and DOPA decarboxylase expression correlated with L-DOPA and dopamine accumulation in striatum and hypothalamus.

Participants / model
Laboratory rats
Treatment
Ladasten 50 mg/kg
Follow-up
Time-course over the first hours after exposure
Study design
Russian preclinical gene-expression and neurochemistry experiment with an English abstract
Funding
Non-U.S. government research support indexed by PubMed

No human experiment in this source tested the mechanism, effect size, or dose relationship.

Read the original source
WADA 2026 · Bromantan prohibited in competition

Official anti-doping standard

World Anti-Doping Agency, effective January 1, 2026

Bromantan appears in S6.A among non-specified stimulants prohibited in competition.

Participants / model
Athletes subject to the World Anti-Doping Code
Treatment
Bromantan exposure
Follow-up
2026 Prohibited List
Study design
Official regulatory standard

Therapeutic-use exemption rules are separate and depend on the applicable anti-doping process.

Read the original source

Why is Bromantane in B tier?

B tier comes from Ladasten's marketed-drug history and several human reports in symptomatic patients. The evidence does not show cognitive enhancement in healthy people, establish long-term safety, or authenticate online powder.

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