Bottom line
Selank is a synthetic heptapeptide (Thr-Lys-Pro-Arg-Pro-Gly-Pro) derived from the endogenous immunomodulatory tetrapeptide tuftsin (Thr-Lys-Pro-Arg) by C-terminal extension with Pro-Gly-Pro for metabolic stability. It is registered in Russia as a prescription anxiolytic for anxiety-spectrum disorders. The clinical evidence base is limited to a small number of Russian-controlled trials with modest sample sizes; no Western-standard regulatory review or independent replication has occurred.
Identity and composition
| Field | Verified information |
|---|---|
| Preferred name | Selank |
| Key aliases | Selank acetate, TP-7, tuftsin analog |
| Molecular/sequence identity | L-Thr-L-Lys-L-Pro-L-Arg-L-Pro-L-Gly-L-Pro (heptapeptide) |
| Modifications/form | C-terminal Pro-Gly-Pro stabilising extension added to tuftsin tetrapeptide; acetate salt common |
| Stable identifiers | CAS 129954-34-3; PubChem CID 11765600; no UNII assigned (not US-registered) |
| Identity caveats | Shares the C-terminal Pro-Gly-Pro motif with Semax but no sequence homology; distinct mechanism (GABAergic vs melanocortin); not to be confused with Semax |
Development and approval status
| Jurisdiction | Status and indication | Product/source | As of |
|---|---|---|---|
| Russia | Approved, Rx — generalized anxiety disorder, neurasthenia, adjustment disorders with anxiety | Selank | 2009 |
| Ukraine | Approved for GAD | Selank | — |
| FDA (US) | Not approved | — | 2026-08 |
| EMA (EU) | Not approved | — | 2026-08 |
| MHRA (UK) | Not approved | — | 2026-08 |
Mechanism and pharmacology
Selank modulates GABA-A receptor activity without directly acting as an agonist (unlike benzodiazepines). It inhibits enkephalinase, increasing endogenous enkephalin levels and opioid tone. The peptide also upregulates BDNF in the hippocampus and frontal cortex and carries tuftsin-derived immunomodulatory activity, including regulation of IL-6 and TNF-α. Gene-expression studies show effects on 80+ genes related to GABAergic transmission, immune function, and stress response. Positron emission tomography indicates selective brain distribution following intranasal administration.
Evidence by claim
| Claim/indication | Stage | Grade | Best human evidence | Main result | Important limitations |
|---|---|---|---|---|---|
| Generalized anxiety disorder | Approved (Russia) | C | Zozulia et al. 2008 (n≈62) | Anxiolytic comparable to medazepam without sedation | Small sample; single-country; English abstract only; PMID 18454096 |
| Phobic-anxiety and somatoform disorders | Approved (Russia) | C | Russian controlled trial (n≈60) | Anxiolytic comparable to phenazepam; effect persisted ~1 week | Full methodology not accessible in English |
| Nootropic / cognitive enhancement | Unapproved off-label | E | — | No adequate human data | Only preclinical and marketing extrapolation |
Key studies
| Study | Design/population | Exposure studied | Endpoints and result | Limitations |
|---|---|---|---|---|
| Zozulia et al. 2008 | GAD and neurasthenia (n≈62); Selank vs medazepam | 250–500 mcg intranasal × 10–14 days | Anxiolytic comparable to medazepam; no sedation | Small; open or single-blind; English abstract only; PMID 18454096 |
| Kozlovskii & Danchev 2003 | Conditioned avoidance (preclinical) | — | Optimising action on learning in rodents | Preclinical; PMID 12617305 |
| Volkova et al. 2016 | Rat gene expression | Selank vs vehicle | Altered GABA-related gene expression | Preclinical; PMID 26924987 |
Dose and administration evidence
Approved labeled regimen
The label summary below is product-, indication-, and jurisdiction-specific; consult the full current label and a licensed clinician/pharmacist.
Russian-approved regimen: 0.15% intranasal solution, 250–500 mcg per dose, 2–3 times daily. Typical course 10–14 days.
Studied regimens (not recommendations)
Clinical studies used the approved intranasal regimen above.
What is not established
Long-term efficacy beyond 14-day courses
Safety and efficacy for off-label uses (social anxiety, PTSD, depression)
Dose for non-approved routes (oral, subcutaneous, intravenous)
Comparative effectiveness against SSRIs or other first-line anxiolytics
Safety
Established label risks
No boxed warnings (not FDA-reviewed). Russian labeling reports: mild nasal irritation, occasional fatigue at higher doses, headache. No sedation or cognitive impairment documented at therapeutic doses. No dependence or withdrawal reported.
Human-study signals
The total published human exposure is approximately 160 patients across 2–3 controlled trials. No serious adverse events reported in these studies.
Unknowns and product-quality risks
No Western pharmacovigilance exists. Long-term safety data are absent. Drug-drug interactions with Western psychotropics (SSRIs, benzodiazepines, antipsychotics) have not been systematically evaluated. Research chemical products lack regulatory quality assurance.
Interactions and special populations
Pregnancy and lactation: no adequate human data; not recommended
Paediatric: safety not established
Hepatic or renal impairment: no dedicated studies
Drug interactions with benzodiazepines, SSRIs, or alcohol: not studied
Regulatory, compounding, and sport notes
WADA: not identified by exact name in the 2026 List. This page records a current Russian governmental approval, so S0 cannot be inferred merely from lack of FDA/EMA approval. Athletes should obtain a current case-specific classification.
US DEA: not scheduled
FDA compounding: Category 2 nomination withdrawn September 2024; no PCAC review scheduled
Not currently on the FDA 503A bulks list
Evidence gaps
No Western-standard RCT published in English with full methodological disclosure
Total published human n ≈ 160; insufficient for regulatory submissions outside Russia
Full Russian-language papers not consistently available for methods review
No independent replication outside the originating research group
Long-term efficacy and safety uncharacterised
No comparator trials against SSRIs/SNRIs
Search notes
Databases and registries: PubMed, PubChem, ClinicalTrials.gov, Russian state register
Search terms: Selank, 129954-34-3, tuftsin analog, anxiety, Zozulia
Last searched: 2026-08-06
Inclusion emphasis: human trials, regulatory records, systematic reviews
Sources
PubChem CID 11765600. https://pubchem.ncbi.nlm.nih.gov/compound/11765600
Zozulia AA et al. (2008) Zh Nevrol Psikhiatr Im S S Korsakova. https://pubmed.ncbi.nlm.nih.gov/18454096/
Kozlovskii IL, Danchev ND (2003) Eksp Klin Farmakol. https://pubmed.ncbi.nlm.nih.gov/12617305/
Volkova EV et al. (2016) Mol Biol (Mosk). https://pubmed.ncbi.nlm.nih.gov/26924987/
Russian Ministry of Health register (2009 approval entry)
FDA 503A Bulk Substances Nominations database. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding