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Evidence: HighPeptideFDA ApprovedPituitary hormoneFDA-approved 1952 · Acthar GelInfantile spasms

Corticotropin

The pituitary hormone sold as Acthar Gel: approved for infantile spasms, debated for much else

Corticotropin, or ACTH, is the pituitary hormone that drives the adrenal glands to make cortisol. In the US it is sold as long-acting gels from pig pituitaries, Acthar Gel and Purified Cortrophin Gel, for infantile spasms, multiple sclerosis relapses and older inflammatory indications.

Overview

What is it?

ACTH is released by the pituitary and stimulates cortisol from the adrenal glands. Injected as a solution it lasts only about 15 minutes in the blood, so the US products are 'repository' gels that release it slowly. Acthar Gel was first approved in 1952 and Purified Cortrophin Gel in 1954, with long lists of older indications approved before modern trial standards.

Its clearest modern evidence is in infantile spasms, a severe epilepsy of babies: in a small randomised trial, 13 of 15 infants on high-dose ACTH responded against 4 of 14 on prednisone, and H.P. Acthar Gel was approved for infantile spasms in 2010. Elsewhere the evidence is thinner, from a nephrotic syndrome trial stopped for lack of efficacy to eye-disease use resting on case reports.

Acthar is not interchangeable with synthetic ACTH, producing about fivefold lower cortisol exposure in volunteers, and it is among the most expensive old drugs in the US. Its label warns of infections, Cushing's syndrome and adrenal insufficiency on withdrawal, raised blood pressure, gastrointestinal bleeding, mood changes and effects on growth and bone.

Structured data

At a Glance

Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.

ClassThe 39-amino-acid pituitary hormone that drives the adrenal glands; sold in the US as long-acting repository gels purified from pig pituitaries, Acthar Gel (first approved 1952) and Purified Cortrophin Gel (1954).
Half-lifeabout 15 minutes in plasma after intravenous ACTH (label); the gel's pharmacokinetics are not adequately characterised
Label dose150 U/m² a day (divided into twice-daily intramuscular injections for 2 weeks, then tapered over 2 weeks (infantile spasms); 80 to 120 units daily for 2 to 3 weeks for MS relapses, intramuscular or subcutaneous)
US statusFDA Approved
Evidence levelHigh
Last reviewed2026-10-03

Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Interactive

Half-Life: How Much Remains

The dataset records a half-life of about 15 minutes in plasma after intravenous ACTH (label); the gel's pharmacokinetics are not adequately characterised for Corticotropin. After each half-life, half of what was in the circulation is gone, so about 3% remains after five. Real clearance varies with the person, the dose, the route and kidney or liver function; this is arithmetic on a published figure, not a dosing tool.

Time since a single dose
Evidence

Published Research

The studies behind corticotropin, read from their PubMed abstracts.

Human1996

High-dose ACTH vs prednisone for infantile spasms

In a randomised trial with a blinded assessor, 13 of 15 infants given ACTH for two weeks stopped spasms and cleared the hypsarrhythmic EEG (86.6%), against 4 of 14 on prednisone (28.6%).

PMID: 8604274
Human2018

ATLANTIS: childhood nephrotic syndrome

A randomised trial in frequently relapsing childhood nephrotic syndrome was stopped at an interim analysis after 31 participants for lack of efficacy: 93% relapsed within six months on ACTH and 94% in the control group, with similar times to first relapse.

PMID: 30442868
Human2022

Acthar vs synthetic ACTH depot

In 48 healthy adults, two doses of repository corticotropin produced about fivefold lower free cortisol exposure, and about fourfold lower estimated steroid exposure, than synthetic ACTH 1-24 depot; the authors conclude the products are not interchangeable.

PMID: 34528408
Human2017

Chronic pulmonary sarcoidosis

In an open study of 16 patients completing 24 weeks, prednisone doses fell and lung diffusion, PET uptake and quality-of-life scores improved, but forced vital capacity did not change; the lower dose worked as well and was better tolerated.

PMID: 28353116
Review2022

Publication bias and cost in eye disease

A review of its use in eye inflammation finds evidence limited to case reports, small series and open-label studies prone to positive publication bias, with unclear advantages over far cheaper oral steroids, and estimates yearly costs of $480,000 to $850,000.

PMID: 34242098
Human2020

Neuroinflammation in infantile spasms

In children with infantile spasms imaged before and after Acthar Gel, focal increases in a neuroinflammation tracer seen in five were reduced or normalised after treatment, as spasms stopped or fell sharply.

PMID: 32576069
Safety

Side Effects & Contraindications

Reported Side Effects

From the studies above.

● Hormonal side effects during high-dose treatment of infants

Contraindications & Cautions

Warnings from the Acthar Gel label (DailyMed, effective July 15, 2026).

● Infections
● Cushing's syndrome, and adrenal insufficiency on withdrawal
● Raised blood pressure, fluid retention, low potassium
● Gastrointestinal bleeding; mood changes; effects on growth and bone
Questions

Frequently Asked Questions

?What is Acthar Gel used for?

Infantile spasms in children under 2 and acute relapses of multiple sclerosis in adults, plus older inflammatory indications.

?Is Acthar the same as synthetic ACTH?

No. In volunteers it produced about fivefold lower cortisol exposure than a synthetic ACTH depot; the two are not interchangeable.

?Why is Acthar so expensive?

A 2022 review estimated yearly costs of $480,000 to $850,000 and found much of the evidence limited to small, open-label studies.

Bibliography

References

  1. [fda] US FDA, Drugs@FDA (openFDA): ACTHAR GEL, NDA 008372 (April 29, 1952); H.P. ACTHAR GEL, NDA 022432 (October 15, 2010); PURIFIED CORTROPHIN GEL, NDA 008975 (June 16, 1954). Read October 3, 2026.
  2. [fda-pi] FDA. Acthar Gel (repository corticotropin injection) US prescribing information (DailyMed set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30, effective July 15, 2026). Read October 3, 2026.
  3. [fda-pi] FDA. Purified Cortrophin Gel (repository corticotropin injection) US prescribing information (DailyMed set f27544ee-a0e2-4d84-b193-1c9efdf9e34c, effective February 9, 2026). Read October 3, 2026.
  4. [clinical-trial] Baram TZ, et al. "High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study." Pediatrics, 1996;97(3):375-9. PMID: 8604274.
  5. [clinical-trial] Wang CS, et al. "Adrenocorticotropic Hormone for Childhood Nephrotic Syndrome: The ATLANTIS Randomized Trial." Clin J Am Soc Nephrol, 2018;13(12):1859-1865. PMID: 30442868.
  6. [clinical-trial] Poola N, et al. "Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH(1-24) Depot and Methylprednisolone in Healthy Subjects." Clin Pharmacol Drug Dev, 2022;11(4):502-515. PMID: 34528408.
  7. [clinical-trial] Baughman RP, et al. "Repository corticotropin for Chronic Pulmonary Sarcoidosis." Lung, 2017;195(3):313-322. PMID: 28353116.
  8. [pubmed] Lobo-Chan AM, et al. "Publication bias, Open-Labeled Trials and Sky Rocketing Costs- Past, Present and Future of Repository Corticotropin Injection?." Ocul Immunol Inflamm, 2022;30(6):1505-1507. PMID: 34242098.
  9. [clinical-trial] Chugani HT, et al. "Neuroinflammation in Children With Infantile Spasms: A Prospective Study Before and After Treatment With Acthar Gel (Repository Corticotropin Injection)." J Child Neurol, 2020;35(12):808-812. PMID: 32576069.

Sources & Citations

Studies were read from their PubMed records; regulatory sources are listed below, read October 3, 2026.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.

Last reviewed: 2026-10-03