Selank

• A synthetic research peptide, studied here in freeze-dried form for injection
• The intranasal formulation has been prescribed in Russia and some CIS countries since the early 2000s (separate product, covered elsewhere)
• No reported dependence or withdrawal profile
• Not approved by FDA, EMA or MHRA

Outcomes actually studied in humans. All human data are from the intranasal product; the injectable format is shown separately.

Reported for the intranasal product

Reported for the freeze-dried injectable format

No controlled human trials of the freeze-dried injectable format have been published.

What human researchers measured, and when. All timings apply to the intranasal product.

Effects reported in human research

• Anxiety-symptom scores (e.g. Hamilton Anxiety) — reduction reported
• Attention and cognitive performance in anxious cohorts — improvement reported
• Autonomic markers (heart-rate variability) — modest changes reported

When outcomes were measured

1. During treatment

   14–21 day course of the intranasal product

2. Day 14

   First anxiety-score measurement in Russian clinical studies

3. Day 21

   End-of-course measurement (Kozlovskaya 2001)

4. Follow-up

   No standardised long-term follow-up in the peer-reviewed literature

5. Injectable format

   No controlled human timeline reported

The freeze-dried injectable format has no human timeline — do not assume the same onset or effect size applies.

• Anxiolytic effect in generalised anxiety disorder without sedation (Kozlovskaya 2001)
• Support during benzodiazepine taper
• BDNF and NGF upregulation (Medvedev 2015)
• Enkephalinase inhibition — endogenous opioid tone protection
• Well-tolerated in Russian clinical experience

Proposed pathways

1. Proposed target

   BDNF & NGF signalling

   ↓→

   Possible downstream effect

   Growth-factor upregulation supporting neuronal resilience

   ↓→Animal

2. Proposed target

   Serotonergic & GABAergic systems

   ↓→

   Possible downstream effect

   Non-benzodiazepine engagement of the anxiety network

   ↓→Proposed

3. Proposed target

   Enkephalinase inhibition

   ↓→

   Possible downstream effect

   Raises endogenous opioid tone without an outside opioid

   ↓→Laboratory

What is not yet known

No systematic safety study of the freeze-dried injectable format has been published. The U.S. FDA's 2020 review of Selank acetate for pharmacy compounding identified potential immunogenicity concerns and concluded important human safety information is lacking. This applies to compounded Selank acetate — not to the registered intranasal product.

Supported by the cited product information. The intranasal product carries a regulatory label; the injectable format does not.

All items below reflect the Russian Selank® intranasal product's regulatory labelling. The freeze-dried injectable format is not subject to a regulatory safety label.

• Pregnancy

  Applies to

  Intranasal Selank®

  Russian Selank® product information (Селанк, official leaflet)

• Breastfeeding

  Applies to

  Intranasal Selank®

  Russian Selank® product information

• Known hypersensitivity to Selank or to any component of the formulation

  Applies to

  Intranasal Selank®

  Russian Selank® product information

• Use under 18 years of age (efficacy and safety were not studied in this population)

  Applies to

  Intranasal Selank®

  Russian Selank® product information

The freeze-dried injectable format has no established regulatory safety profile — no FDA, EMA or MHRA authorisation, and no controlled human safety data for the injectable route. Any use of it is fully research-context.

• Is Selank an approved medicine?

  Yes — in Russia and some CIS countries (Belarus, Kazakhstan), as a 0.15% intranasal solution branded Selank®, since the early 2000s. It has never been approved by the FDA, EMA, or MHRA.

• How is Selank related to tuftsin?

  Tuftsin is a natural tetrapeptide (Thr-Lys-Pro-Arg) released from the IgG heavy chain. Selank keeps that tuftsin core and adds a Pro-Gly-Pro C-terminal tail. The extension dramatically increases plasma stability and gives Selank an anxiolytic profile tuftsin itself does not have.

• Is Selank the same as a benzodiazepine?

  No. Selank engages the GABAergic system but not by direct GABA-A receptor modulation. Its main anxiolytic mechanism appears to involve BDNF/NGF upregulation and enkephalinase inhibition. Russian clinical use does not report the sedation or dependence pattern seen with benzodiazepines.

• How does Selank differ from Semax?

  Both come from the same Russian regulator-peptide programme. Semax is an ACTH(4-10) analogue targeted at stroke recovery and cognition; Selank is a tuftsin derivative targeted at anxiety and asthenic states. Both are Russian-registered intranasal medicines with different mechanisms and indications.

• Why isn't Selank available in the US or EU?

  No Western sponsor has filed a regulatory dossier. The Russian registration rests on Russian clinical evidence, and no ICH-GCP randomised placebo-controlled trial by a Western sponsor has been published.

1. [1]

   Regulatory peptides Selank and Semax — a developer's consolidating review of design principles, chemistry and clinical evidence — Myasoedov NF, Russian Journal of Bioorganic Chemistry / review (2011)

2. [2]

   Clinical efficacy of Selank in generalised anxiety disorder and neurasthenia — a representative Russian clinical study — Kozlovskaya MM, Kozlovskii II, Val'dman EA, Seredenin SB, Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova (2001)

3. [3]

   Mechanistic characterisation of Selank — BDNF/NGF upregulation and enkephalinase inhibition — Medvedev AE, Gnedenko OV, Ershov PV, et al., Neurochemistry-focused Russian journal (2015)

4. [4]

   Selank® pharmaceutical registration documentation — Russian State Registry of Medicinal Products — Russian State Registry of Medicinal Products, Regulatory registry documentation (2003)

5. [5]

   Peptides & Compounds — The No-Jargon Guide (v5) — Healthy Mango Editorial, Healthy Mango practitioner reference (2026)