P 040Semax

配列から構築した理想化コンフォマー。実験構造でも予測構造でもありません。

P 040 · 2D化学構造（2D）

PubChem SMILES からの 2D 描写

P 0402026-08-06に検証済み

承認された薬

Semax

エイリアス: ACTH(4-7)-Pro-Gly-Pro · Semax acetate · Met-Glu-His-Phe-Pro-Gly-Pro

Approved in Russia as a prescription nootropic/stroke treatment since 1994; not approved in the US, EU, UK, or Canada.

精神神経科ブレンド中: Semax+Selank ブレンド中: Focus Stress & Sleep Blend

同一性記録

クラス: neuropsychiatric
残基: 記録されていない
パブリケム CID: 9811102
検証: 2026-08-06
修正: C-terminal Pro-Gly-Pro stabilising extension added to ACTH(4-7); acetate salt common
アイデンティティに関する注意事項: Exact-name resolver title: ACTH (4-7), Pro-Gly-Pro-

L-Met-L-Glu-L-His-L-Phe-L-Pro-L-Gly-L-Pro (heptapeptide)

平易な言葉で

このページは Semax についての構造化された研究要約です:それが何か、管轄区域ごとの承認状況、考えられている作用機序、主張される各用途の根拠となるエビデンス、安全性と規制について分かっていること。

主張される用途はそれぞれ A(添付文書上の用途として確立)から X(否定または非支持)まで個別に評価されます。評価は個々の主張に対するもので、化合物全体への評価ではありません。承認状況とエビデンス評価は別の問いに答えるものです。

このページから: Best-supported claim on this page: Acute ischemic stroke (adjunct) (Grade B), with the listed limitations.

個人への推奨は一切ありません。承認された用量は現行の公式添付文書からの要約のみ、研究で使われた用法は記述のみで推奨ではなく、未承認の化合物には「No established or recommended human dose.」と明記されます。

知らない用語がありますか?用語集を開く

証拠の内容は英語で管理されます。

Semax の理想的な構造図 — 配列から構築した理想化コンフォマー。実験構造でも予測構造でもありません。

ひと目でわかる

ENTRY TYPE: approved drug
IDENTITY: Sequence verified
TOP EVIDENCE: Grade B — Acute ischemic stroke (adjunct)
MAJOR STATUS: Jurisdiction-specific — see status table
SPORT: Check current rules — as of 2026-08-06
VERIFIED: 2026-08-06

Bottom line

Semax is a synthetic heptapeptide (Met-Glu-His-Phe-Pro-Gly-Pro) derived from the ACTH(4-10) fragment by C-terminal extension with Pro-Gly-Pro for metabolic stability. It is a registered prescription medicine in Russia for acute ischemic stroke, cognitive impairment, and optic neuropathy, but has not undergone review by the FDA, EMA, or MHRA. The evidence base consists predominantly of Russian clinical studies; no large Western-standard multi-center has been conducted.

Identity and composition

Field	Verified information
Preferred name	Semax
Key aliases	ACTH(4-7)-Pro-Gly-Pro, Semax acetate
Molecular/sequence identity	L-Met-L-Glu-L-His-L-Phe-L-Pro-L-Gly-L-Pro (heptapeptide)
Modifications/form	C-terminal Pro-Gly-Pro stabilising extension added to ACTH(4-7); acetate salt common
Stable identifiers	CAS 80714-61-0; 9811102; UNII I5FAL2585H
Identity caveats	Distinct from native ACTH — sequence modification eliminates steroidogenic activity; PubChem lists a related entry under CID 155977617

Development and approval status

Jurisdiction	Status and indication	Product/source	As of
Russia	Approved, Rx — acute ischemic stroke (0.1% nasal), cognitive impairment/asthenia (1% nasal), optic neuropathy	Semax (PEPTEK)	1994 (initial); listed on Vital and Essential Drugs 2011
Ukraine	Approved for similar neurological indications	Semax	—
FDA (US)	Not approved	—	2026-08
EMA (EU)	Not approved	—	2026-08
MHRA (UK)	Not approved	—	2026-08
Health Canada	Not approved	—	2026-08

Status is multi-axis

Authorization belongs to the named product, use, place, and date; sport status is independent.

テキストによる説明

UNITED STATES: FDA (US): Not approved
EU/EEA: EMA (EU): Not approved
UNITED KINGDOM: MHRA (UK): Not approved
OTHER DOCUMENTED: Russia: Approved, Rx — acute ischemic stroke (0.1% nasal), cognitive impairment/asthenia (1% nasal), optic neuropathy; Ukraine: Approved for similar neurological indications; Health Canada: Not approved

Sport status: 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.

Mechanism and pharmacology

Semax acts as a melanocortin receptor modulator (MC3R, MC4R) without stimulating adrenal corticosterone production. It upregulates BDNF and NGF expression in the brain, modulates serotonergic and dopaminergic neurotransmission, and exerts anti-inflammatory effects in ischemia models through suppression of proinflammatory mRNA transcripts. The peptide crosses the blood-brain barrier efficiently via intranasal administration. Evidence for these mechanisms is predominantly from studies and Russian clinical research.

Evidence by claim

Claim/indication	Stage	Grade	Best human evidence	Main result	Important limitations
Acute ischemic stroke (adjunct)	Approved (Russia)	B	Gusev et al. 2005 (n=110+)	Improved Barthel index and motor scores vs standard care	Open or single-blind; no Western-standard multicentre
Cognitive impairment (chronic cerebrovascular)	Approved (Russia)	C	Gusev et al. 2005 (n=187)	Reduced stroke/TIA risk, clinical improvement	Single-country; limited methodological detail in English
Nootropic in healthy adults	Unapproved off-label	E	—	No adequate -controlled trials in English	Only marketing extrapolations available
Optic neuropathy	Approved (Russia)	C	Russian clinical series	Visual function improvement claimed	No controlled trial published in English

エビデンスグレード

AグレードA: 特定の表示使用に対して確立
BグレードB: 中等度のヒトエビデンス
CグレードC: 予備的ヒトエビデンス
DグレードD: 前臨床のみ
EグレードE: 逸話的/マーケティング主張
XグレードX: エビデンスが主張と矛盾するか、支持しない

エビデンスグレーディングの詳細

Claim-evidence profile

This counts the page's claim rows; it does not average them into a score.

テキストによる説明

Text alternative for the claim-evidence diagram. Each grade is defined below:

A — Established for a specific labeled use: 0 claims
B — Moderate human evidence: 1 claim: Acute ischemic stroke (adjunct)
C — Preliminary human evidence: 2 claims: Cognitive impairment (chronic cerebrovascular); Optic neuropathy
D — Preclinical only: 0 claims
E — Anecdotal/marketing claim: 1 claim: Nootropic in healthy adults
X — Evidence contradicts or does not support the claim: 0 claims

United StatesNot approved

EU/EEANot approved

United KingdomNot approved

OtherApproved, Rx — acute ischemic stroke (0.1% nasal), cognitive impairment/asthenia (1% nasal), optic neuropathyApproved for similar neurological indicationsNot approved

Key studies

Study	Design/population	Exposure studied	Endpoints and result	Limitations
Gusev et al. 2005	Acute stroke (n=110+); intranasal Semax vs standard care	6–18 mg/day × 5–10 days	Improved Barthel index, MRC motor scores	Single-country; limited English-language methods; PMID 15792140
Gusev et al. 1997	Acute stroke (n=110+); phase 2/3	6–18 mg/day × 5–10 days	Neurological recovery improvement	Preliminary report; PMID 11517472
Dergunova et al. 2021	Rat ischemia model	Semax vs vehicle	Suppressed proinflammatory mRNA transcripts	only; PMID 34107114

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 regimens (intranasal solution):

Acute ischemic stroke (moderate): 12 mg/day × 5–10 days
Acute ischemic stroke (severe): 18 mg/day × 5–10 days
Post-stroke recovery: 6 mg/day across two 10-day courses
Cognitive/nootropic: 0.1% nasal solution, typical course 10–14 days

Studied regimens (not recommendations)

Clinical studies used the approved intranasal doses above.

What is not established

Long-term or repeated-course safety and efficacy
Dose for any non-approved indication (cognitive enhancement in healthy adults, neurodegeneration)
Compatibility with any compounding formulation outside the registered product

Safety

Established label risks

No boxed warnings (not FDA-approved). Russian labeling lists: mild nasal irritation, occasional headache, mild insomnia with late-day dosing. Contraindications: acute psychosis, pregnancy/breastfeeding, seizure disorders (caution), hypersensitivity.

Human-study signals

Mild blood-glucose elevations reported in ~7.4% of diabetic patients in Russian post-marketing surveillance. No documented dependence, withdrawal syndrome, or HPA-axis suppression.

Unknowns and product-quality risks

No Western pharmacovigilance data exist. Long-term safety beyond 14–30 day courses has not been systematically studied. BDNF/NGF upregulation raises a theoretical concern for patients with neural tumours. No large reproductive toxicology study in English. Products sold as "research use only" outside Russia lack regulatory oversight, sterility assurance, and dose consistency.

Interactions and special populations

Russian labeling: caution in diabetes (monitor glucose); contraindicated in pregnancy and breastfeeding
Drug-drug interaction data with Western psychotropics are absent
No paediatric safety studies in English
No interaction studies identified

Regulatory, compounding, and sport notes

: not identified by exact name in the 2026 List. This page records a current Russian governmental approval, so cannot be inferred merely from lack of FDA/EMA approval. Athletes should obtain a current case-specific classification.
US DEA: not scheduled
Listed on Russian List of Vital and Essential Drugs
Semax was not found on the reviewed FDA bulks list. That absence does not by itself resolve whether a particular preparation satisfies sections 503A or 503B; a current fact-specific assessment is required.

Evidence gaps

No large multi-centre meeting Western regulatory standards
No independent Western replication of Russian stroke or cognition data
Most original literature is in Russian-language journals with limited methods reporting
Long-term and repeated-course safety uncharacterised
Cognitive enhancement in healthy adults lacks -controlled trials

Search notes

Databases and registries: PubMed, PubChem, DailyMed/GSRS, ClinicalTrials.gov, Russian state register
Search terms: Semax, ACTH(4-10), 80714-61-0, Gusev, ischemic stroke
Last searched: 2026-08-06
Inclusion emphasis: human trials, regulatory records, systematic reviews, authoritative identity databases

Sources

PubChem CID 9811102. https://pubchem.ncbi.nlm.nih.gov/compound/9811102
GSRS UNII I5FAL2585H. https://gsrs.ncats.nih.gov/
Gusev EI et al. (2005) Zh Nevrol Psikhiatr Im S S Korsakova. PMID 15792140
Gusev EI et al. (1997) Zh Nevrol Psikhiatr Im S S Korsakova. PMID 11517472
Dergunova LV et al. (2021) Int J Mol Sci. PMID 34107114
Russian government decree No. 2139-r (2011) — List of Vital and Essential Drugs

専門家の声

専門家の見解

コメントは個人の見解であり、エビデンスレビューの一部ではありません。掲載は支持を意味しません。

この化合物について、本アトラスが受け入れる情報源 — 査読付き文献、大学・病院・医学会の発表、規制当局、署名入りサイエンスジャーナリズム — において、検証済みの専門家コメントは見つかりませんでした。

コメントがないことは、化合物に関するいずれの方向の証拠にもなりません。

ベンダー、クリニック、ソーシャルメディアの主張はポリシーにより除外され、コメントとしてカウントされません。

この化合物について、本アトラスの情報源において検証済みの専門家ビデオは見つかりませんでした。

ビデオコメントがないことは、化合物に関するいずれの方向の証拠にもなりません。

ベンダーとソーシャルメディアのビデオはポリシーにより除外され、カウントされません。

質問

Is Semax FDA-approved?

Semax is not approved by the FDA, EMA, MHRA, or Health Canada. It is approved in Russia as a prescription nootropic and stroke treatment since 1994, and also approved in Ukraine for similar neurological indications. Status in other jurisdictions requires a current national-register check.

What does the evidence show for Semax and acute ischemic stroke?

Semax is approved in Russia for acute ischemic stroke based on studies such as Gusev et al. 2005 (n=110+), which reported improved Barthel index and motor scores versus standard care. The evidence is graded B and is limited by open or single-blind designs with no Western-standard multicentre RCT.

Is Semax the same as ACTH?

Semax is derived from the ACTH(4-7) fragment but is distinct from native ACTH. Its C-terminal Pro-Gly-Pro stabilising extension eliminates steroidogenic activity, meaning it does not stimulate adrenal corticosterone production. It has a different sequence and pharmacological profile from native ACTH.

What are Semax's main safety signals?

Russian labeling reports mild nasal irritation, occasional headache, and mild insomnia when taken late in the day. Mild blood-glucose elevations occurred in ~7.4% of diabetic patients in post-marketing surveillance. No dependence, withdrawal, or HPA-axis suppression is documented. No Western pharmacovigilance data exist.

Is Semax prohibited in sport?

Semax was not identified by exact name in the 2026 WADA Prohibited List. The monograph notes that because Semax has current Russian governmental approval, S0 classification cannot be inferred merely from lack of FDA/EMA approval. Athletes should obtain a current case-specific classification.

Does Semax have Western-standard clinical trial evidence?

No. No large multi-centre double-blind RCT meeting Western regulatory standards has been conducted. Most of the original literature is in Russian-language journals with limited methods reporting, and no independent Western replication of Russian stroke or cognition data has occurred.

研究の最新情報

アトラスに参加してください。証拠の最新情報を入手します。

ペプチドの証拠、ステータス、またはソース記録が変更されたときに簡潔なメモを受け取ります。

ひと目でわかる

01 —Bottom line

02 —Identity and composition

03 —Development and approval status

04 —Mechanism and pharmacology

05 —Evidence by claim

06 —Key studies

07 —Dose and administration evidence