Straight answers
Common questions about Semax / Selank Injection.
- What is the FDA status of Semax / Selank Injection?
- No compounding pathway today. Semax (heptapeptide): Semax is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 24, 2026. A recommendation is not a listing: nothing changes unless FDA publishes a final rule. Checked against primary sources on October 13, 2026. Selank acetate (TP-7): Selank is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 on September 27, 2024, because the nominator had meant to nominate a different substance. FDA's Pharmacy Compounding Advisory Committee has not reviewed it, and nothing is pending. Checked against primary sources on October 13, 2026.
- Is compounded Semax / Selank Injection an approved drug?
- No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. The Semax / Selank Injection combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
- What does the evidence support for Semax / Selank Injection, and what does it not?
- Published human studies of the individual peptides are limited. Results for either peptide alone cannot be transferred to a mixture, and PEPLUX has not verified clinical evidence establishing the safety or effectiveness of this combination.
- What are the risks of Semax / Selank Injection?
- The safety of semax and selank together has not been established. Side effects, interactions and longer-term risks of the mixture are not adequately characterized. The full list of side effects, and of who should not use Semax / Selank Injection, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
- Does Semax / Selank Injection require baseline labs?
- Your prescriber determines whether baseline labs are needed before considering Semax / Selank Injection. Baseline labs are included in the price.
- What does Semax / Selank Injection cost?
- $229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
- Is Semax / Selank Injection prohibited in sport?
- Semax (heptapeptide): Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed. Selank acetate (TP-7): Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.
- How is Semax / Selank Injection given?
- Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.