Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Repository corticotropin injection (Acthar Gel, Purified Cortrophin Gel): what the evidence says

Name: Repository corticotropin injection (Acthar Gel, Purified Cortrophin Gel)
Published: 2026-10-27

At a glance

What it is: a long-acting gel of adrenocorticotropic hormone (ACTH) purified from pig pituitary glands, which prompts the adrenal glands to make cortisol and related steroids. Acthar Gel's label describes it as a complex mixture of ACTH analogs and other pituitary peptides, mainly a modified porcine ACTH(1-39). It was first approved in 1952; Acthar is approved for infantile spasms (since 2010) and multiple sclerosis relapses, and both Acthar and Purified Cortrophin Gel list many rheumatic, skin, allergic, eye, lung and kidney conditions. ^{R1, R2, R3, R4, R5}

What the evidence says: Human one small blinded RCT found it worked better than prednisone for infantile spasms (13 of 15 vs 4 of 14). ^R6 A 2022 review of the evidence found few RCTs for most approved uses, and most found it no better than corticosteroids for MS relapses or infantile spasms. ^R7

Biggest risks: side effects mirror steroids: infections, high blood pressure, salt and water retention, low potassium, stomach bleeding, mood changes, bone loss, cataracts and adrenal suppression after stopping. Prohibited in sport. ^{R4, R8}

Rating


Human Human evidence	Moderate: small RCTs and a scoping review ^{R6, R7, R9}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved ^R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R10, R11, R12} · prohibited at all times (WADA S2.2.2) ^R8
Established human dose	Yes, label dose (see Study details)

Evidence verdict: Infantile spasms: Moderate (small RCTs) · Multiple sclerosis relapses: Moderate (better than placebo, not shown better than steroids) · Rheumatologic, eye and other listed uses: Very limited (few small trials) · Other uses: No human data reviewed

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: approval predates modern standards; trials are small and mostly compare against placebo or steroids.

What is it?

Related pages: cosyntropin.

Does it work?

Human Infantile spasms (Baram 1996, 29 infants): response 86.6% with ACTH vs 28.6% with prednisone. ^R6
Human Evidence review (2022): 6 randomized studies in infantile spasms, only 1 small RCT showed superiority over steroids; MS trials generally better than placebo but no different from steroids. ^R7
🟨 MS relapse not helped by steroids (35 patients): more EDSS responders than placebo. ^R9

Is it safe?

Warnings: infections, Cushing's syndrome and adrenal insufficiency after withdrawal, raised blood pressure, GI bleeding, mood changes, eye effects, bone loss, effects on growth in children. ^R4
Contraindicated for IV use, with live vaccines at immunosuppressive doses, and with porcine protein allergy, among others. ^{R4, R5}

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, prescription (Acthar Gel; Purified Cortrophin Gel). ^{R1, R2, R3}
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R10, R11, R12}
Sport: prohibited at all times; corticotrophins are named as a class under WADA S2.2.2. ^R8

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Baram 1996	29 infants with infantile spasms	IM	150 U/m²/day vs prednisone 2 mg/kg/day	2 weeks	Response 86.6% vs 28.6%	PMID 8604274
Wynn 2022	35 adults, MS relapse not responding to steroids	SC	80 U daily, per study	14 days, followed to day 42	More EDSS responders vs placebo	PMID 34984839
Tran 2022 scoping review	41 studies (2,235 participants) across approved uses	Various	Various	Varied	Few RCTs; mostly not better than steroids	PMID 34902005

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Drugs@FDA, Acthar Gel (repository corticotropin), application NDA008372 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA008372
^R2 Drugs@FDA, H.P. Acthar Gel (repository corticotropin), application NDA022432 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA022432
^R3 Drugs@FDA, Purified Cortrophin Gel (repository corticotropin), application NDA008975 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA008975
^R4 Acthar Gel prescribing information, label published Oct 16, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b48ddec-e815-45f4-9ca0-5c0daaf56f30
^R5 Purified Cortrophin Gel prescribing information, label published Oct 8, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f27544ee-a0e2-4d84-b193-1c9efdf9e34c
^R6 Baram TZ, et al. Pediatrics. 1996. PMID 8604274
^R7 Tran KA, et al. JAMA Intern Med. 2022. PMID 34902005
^R8 WADA. The 2026 Prohibited List, S2.2.2, Corticotrophins and their releasing factors (class named; tetracosactide given as an example). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R9 Wynn D, et al. CNS Neurosci Ther. 2022. PMID 34984839
^R10 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R11 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R12 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Repository corticotropin injection (Acthar Gel, Purified Cortrophin Gel). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).