Research information only, not medical advice. Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 24, 2026 (evaluated indication: Cerebral ischemia, migraine, trigeminal neuralgia). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.
Semax at a glance
As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.
All seven peptides on the agenda are covered in the July 2026 FDA peptide meeting.
Evidence profile
58 studies- Human RCT 1 · 2%
- Human trial 4 · 7%
- Review 14 · 24%
- Animal 31 · 53%
- In-vitro 5 · 9%
- Unknown 3 · 5%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
- 2026-04-22 US-FDA
Removed from the FDA 503A 'do not compound' Category 2 (nominations withdrawn) — still not eligible for compounding. source
- 2026-07-24 US-FDA · upcoming
FDA Pharmacy Compounding Advisory Committee vote (evaluated indication: Cerebral ischemia, migraine, trigeminal neuralgia); docket FDA-2025-N-6895. source
Indexed research
Sorted by evidence level, strongest first.
- Human RCT 2022[Results of the application of complex physiotherapeutic neurostimulation in optical neuropathies of various genesis]
This randomized controlled trial in 60 patients with vascular optic neuropathy found that complex physiotherapeutic neurostimulation improved visual function more than vitamin therapy alone.
- Human trial 2026Digitally Guided Hybrid Maxillary Expansion with Supragingival Mandibular Miniplates for Class III Correction in Late Adolescents: A Pilot Clinical Study
This pilot clinical study describes a digitally guided hybrid maxillary expansion and mandibular miniplate protocol for Class III correction in late adolescents, showing significant maxillary advancement with minimal side effects.
- Human trial 2022Diagnostic Value of Different 3-D Shear Wave Elastography Sections in the Diagnosis of Thyroid Nodules
This study evaluates the diagnostic value of 3-D shear wave elastography combined with ACR TI-RADS for differentiating malignant from benign thyroid nodules in 188 patients.
- Human trial 2025РЕЗУЛЬТАТЫ МЕДИКАМЕНТОЗНОЙ ПРОФИЛАКТИКИ ВОЗНИКНОВЕНИЯ И ПРОГРЕССИРОВАНИЯ ДИАБЕТИЧЕСКОЙ РЕТИНОПАТИИ
This study evaluated drug prevention of diabetic retinopathy occurrence and progression in 168 patients with type 2 diabetes, finding positive effects with calcium Dobesylate and Semax.
- Human trial 2025Study of the effectiveness of the drug «Semax» in the complex treatment of non-proliferative diabetic retinopathy
This study evaluates the effectiveness of Semax combined with calcium dobesilate in preventing progression of non-proliferative diabetic retinopathy in 87 patients.
- Review 2026Therapeutic peptides in gerontology: mechanisms and applications for healthy aging
- Review 2026Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions
- Review 2025Modulation of neuropathological pathways by bioactive peptides and proteins/polypeptides: Targeting oxidative stress in neurodegenerative diseases
- Review 2026Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives
- Review 2023Neuroprotective Peptides and New Strategies for Ischemic Stroke Drug Discoveries
+ 48 more studies indexed for Semax.
Frequently asked questions
- Is Semax approved for human use?
- Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 24, 2026 (evaluated indication: Cerebral ischemia, migraine, trigeminal neuralgia). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.
- What does the research on Semax show?
- As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.