§1 · Regulatory Standing
Where bromantane stands, jurisdiction by jurisdiction
| Jurisdiction | Status |
|---|---|
| Russia | Approved prescription medicine — Ladasten, 50 mg tablets, for asthenic disorders / neurasthenia; in the Russian State Register of Medicines (manufacturer Lekko CJSC). Approved around 2009 following the 2005-era repurposing programme. |
| United States | Unscheduled but not FDA-approved — no approved medical use; present in the grey market as a "research chemical". |
| EU / UK / elsewhere | No marketing authorisation identified — treated as unapproved outside Russia. |
| Sport | Prohibited since 1997 after detection at the 1996 Atlanta Olympics; long urinary detectability of metabolites keeps it a doping-control target. Athletes should consult the current WADA Prohibited List for exact placement. |
§2 · The Clinical Record
Human trials Clinical
- ANCHOR · RCT — Neznamov GG, Siuniakov SA, Teleshova SE, et al. Ladasten, the new drug with psychostimulant and anxiolytic actions in treatment of neurasthenia (results of the comparative clinical study with placebo). Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(5):20-6. PMID 19491814
- ANCHOR · MULTICENTRE — Voznesenskaia TG, Fokina NM, Iakhno NN. Treatment of asthenic disorders in patients with psychoautonomic syndrome: results of a multicenter study on efficacy and safety of ladasten (728 patients, 28 centres). Zh Nevrol Psikhiatr Im S S Korsakova. 2010;110(5 Pt 1):17-26. PMID 21322821
- PILOT — Siuniakov SA, et al. Pilot clinical trial of ladasten. Eksp Klin Farmakol. 2006;69(4):10-5. PMID 16995430
§3 · The Mechanism Record
Gene expression, plasticity, epigenetics Animal
- CORE — Vakhitova IuV, Iamidanov RS, Seredinin SB. Ladasten induces the expression of genes regulating dopamine biosynthesis in various structures of rat brain. Eksp Klin Farmakol. 2004;67(4):7-11. PMID 15500036
- CORE — Mikhaylova M, Vakhitova JV, Yamidanov RS, et al. The effects of ladasten on dopaminergic neurotransmission and hippocampal synaptic plasticity in rats. Neuropharmacology. 2007;53(5):601-8. PMID 17854844 · doi:10.1016/j.neuropharm.2007.07.001
- MICRODIALYSIS — Grekhova TV, et al. Bromantane and striatal dopamine. Biull Eksp Biol Med. 1995;119(3):302-4. PMID 7795203
- EPIGENETIC — Vakhitova 2006, TH-promoter demethylation (Genetika; cited via the review literature). PMID 16915929
- NEUROTROPHINS · SINGLE SOURCE — Salimgareeva 2012, BDNF/NGF and MAP-kinase activation. Bull Exp Biol Med. doi:10.1007/s10517-012-1516-z.
§4 · Performance, Toxicology, Immunity
The animal literature Animal
- ENDURANCE — Morozov IS, Kleimenova NN. Bromantane and physical work capacity. Eksp Klin Farmakol. 1998;61(6):51-3. PMID 9929819
- HEAT — Badyshtov 1995, thermoprotective effects during overheating. PMID 7793100
- MOTIVATION — Morozov 2000, motivational component in operant behaviour. PMID 10934588
- DEPENDENCE — Iezhitsa IN, et al. 2000, absence of dependence/withdrawal on chronic administration. PMID 11109517
- TOXICOLOGY — Iezhitsa IN, et al. 2002, single-dose toxic/neurological status. PMID 12124651 · Bugaeva LI, et al. 2000, acute toxicity. PMID 10763112
- IMMUNITY — Tallerova AV, et al. 2014, T-cell normalisation in chronic stress. PMID 24771370 · Tallerova AV, et al. 2011, IL-6/IL-17 in an anxiety-depression model. PMID 22803040
§5 · The Anchor Review and the Doping Report
Secondary and historical records Review
- ANCHOR REVIEW · OPEN ACCESS — Oliynyk S, Oh S. The pharmacology of actoprotectors: practical application for improvement of mental and physical performance. Biomol Ther (Seoul). 2012;20(5):446-56. PMC3762282 · PMID 24009833 · doi:10.4062/biomolther.2012.20.5.446
- DOPING DETECTION — Burnat P, Payen A, Le Brumant-Payen C, Hugon M, Ceppa F. Bromontan, a new doping agent. Lancet. 1997;350(9082):963-4. PMID 9314900 · doi:10.1016/S0140-6736(05)63310-7
- IDENTITY — Bromantane compound record (structure, formula, identifiers). PubChem CID 4660557 · orientation: Wikipedia "Bromantane" (orientation only; every used claim cross-checked to the primary records above).
§6 · What We Do Not Claim
The unverified list Not asserted
Held out of this monograph pending sourcing
- Cosmonaut or space use of bromantane itself (that history belongs to bemitil).
- Exact current WADA Prohibited List subsection wording.
- Sigma-1 receptor agonism as bromantane's mechanism (hypothesised for adamantanes, never demonstrated for bromantane).
- Antidepressant efficacy in humans (animal models only).
- Human pharmacokinetic values beyond the Russian label figures.
- Motivation or drive claims in humans (animal operant data only).
§7 · The Panacea Programme
Ongoing investigation — and its limits
Panacea Bio Chem — Molecular-Performance & Formulation Research Programme
Panacea Bio Chem is investigating bromantane within its molecular-performance and formulation research programme. The scope is analytical characterisation, actoprotector mechanism literature, and formulation science for adamantane-class compounds. The programme is ongoing: this site asserts no internal results, reports no unpublished data, and will add findings here only when they have survived the same sourcing discipline applied to the record above. Questions about the programme can be put to us through the Panacea IQP.