Is corticotropin FDA-approved, and what does the research show?

What is corticotropin?

Corticotropin is the drug name for ACTH, adrenocorticotropic hormone ². ACTH is "the anterior pituitary hormone," made by the pituitary gland at the base of the brain and released into the blood ². It makes the adrenal glands, one above each kidney, "secrete cortisol" and the other "adrenocortical hormones," the steroid hormones of the adrenal cortex ¹, ². Cortisol is the best known of these steroid hormones, and the label calls the drug's effects "steroidogenic," steroid-making ¹.

As a medicine, corticotropin is not built in a laboratory. Acthar Gel is "a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides," made from "porcine pituitary extract," which is pig pituitary glands ⁶, ¹. Purified Cortrophin Gel is "a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin" ². The gelatin gives "a prolonged release after intramuscular or subcutaneous injection" ¹. The products' full name is repository corticotropin injection ¹, ².

Both products are prescription medicines for serious diseases, not wellness, weight or performance peptides ¹, ². Cosyntropin, "a synthetic subunit of ACTH" approved as a diagnostic test, is a different product with its own page ⁷.

Is corticotropin FDA-approved?

Yes. Corticotropin is approved by FDA in two prescription products, both injections, both first approved in the 1950s ³, ⁴. Acthar Gel's infantile spasms use came under a second application, NDA 022432, in 2010 ³, ⁸.

Drugs@FDA, FDA's public register of approved drugs, shows new drug application (NDA) 008372 for Acthar Gel approved on April 29, 1952 ³. Its marketing status is "Prescription" ³. NDA 008975 for Purified Cortrophin Gel was approved on June 16, 1954, and carries the same status ⁴.

The Acthar Gel label approves it "as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age" ¹. Infantile spasms are a seizure disorder of infancy, and the approval trial admitted infants with spasms and hypsarrhythmia, an abnormal pattern on the brain-wave recording (EEG), or its variants ¹, ⁵. Monotherapy means the drug is used alone. The label also approves it "for the treatment of acute exacerbations of multiple sclerosis in adults" ¹. An exacerbation, which the trials also call a relapse, is a flare of the disease's symptoms ⁹, ¹⁰.

The label then lists seven further categories, "rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state," and names conditions under each ¹. Among them are psoriatic and rheumatoid arthritis "as adjunctive therapy for short-term administration," systemic lupus erythematosus, and "severe erythema multiforme, Stevens-Johnson syndrome" ¹. The list goes on to "serum sickness," eye inflammation such as "optic neuritis," "symptomatic sarcoidosis," and the nephrotic syndrome, a kidney disorder, "to induce a diuresis or a remission of proteinuria," that is, to make the kidneys pass water or stop leaking protein ¹. Purified Cortrophin Gel's label carries a similar list, with "acute exacerbations of multiple sclerosis" under "nervous system," and no infantile spasms indication ².

FDA's 2010 approval letter, which calls the product H.P. Acthar Gel, says it "was approved on April 29, 1952, for multiple indications," and that "the label was later expanded to include multiple sclerosis (MS) in 1972" ⁸. FDA was then "adding the indication of infantile spasms in pediatric patients," by the letter dated October 15, 2010 ⁸.

In 2026 FDA told Acthar Gel's maker of "new safety information that we have determined should be included in the labeling for adrenocorticotropic hormone (ACTH) products" ¹¹. The information "pertains to the risk of drug hypersensitivity," and FDA approved a revised label for each product on October 5, 2026 ¹¹, ³, ⁴.

See the FDA status of every peptide, updated weekly.

How does corticotropin work?

Acthar Gel acts as the body's own ACTH does, since both "stimulate the adrenal cortex," the adrenal gland's outer shell, to release its steroid hormones ⁶, ¹. The Purified Cortrophin Gel label adds that "the action of corticotropin is similar to that of exogenous adrenocortical steroids," steroid medicines given from outside ². This account is the two labels' own, for approved drugs ¹, ². The Purified Cortrophin Gel label cites one human study, "an open label pharmacodynamic study" of 20 healthy volunteers, in which blood cortisol peaked a median of 8 hours after a single injection ².

For infantile spasms the label states that "the mechanism of action of Acthar Gel in the treatment of infantile spasms is unknown" ⁶, ¹. The label says the drug "is also reported to bind to melanocortin receptors" ⁶, ¹. Its effects on the adrenal cortex "are not well understood beyond the fact that they appear to be mediated by cyclic AMP," a signal molecule inside cells ⁶, ¹.

The body normally switches ACTH off when cortisol rises, since "elevated plasma cortisol suppresses ACTH release" ¹. Prolonged large doses make the adrenal cortex enlarge and keep up a "continuous high output of cortisol, corticosterone and weak androgens" ¹. Natural ACTH leaves the blood quickly, with a half-life, the time for half of it to clear, of about 15 minutes ⁶, ¹. "The pharmacokinetics of Acthar Gel," how the body handles the drug, "have not been adequately characterized" ⁶, ¹.

What does the research show?

The evidence level is the top step of the scale, FDA approval for a use ¹. The label's Clinical Studies section rests the infantile spasms approval on two randomized trials in infants, one main and one supportive ¹. For multiple sclerosis the label cites "controlled clinical trials" without naming them ¹.

Studied in people for infantile spasms: the label's main trial, published in March 1996, randomized 29 infants, median age 6 months ⁵, ¹. They received two weeks of high-dose ACTH or of prednisone, a steroid given by mouth ⁵, ¹. Entry required clinical spasms, hypsarrhythmia or its variants during a full sleep-cycle video-EEG recording, and no earlier steroid or ACTH treatment ⁵.

A response required both the spasms to stop and the hypsarrhythmia to clear, judged by an investigator blinded to treatment, that is, not told which drug each infant had ⁵, ¹. Thirteen of 15 infants on ACTH responded, 86.7 percent, against 4 of 14 on prednisone, 28.6 percent ¹, ⁵. The label gives p<0.002, meaning chance alone would produce a gap that size less than 0.2 percent of the time ¹. The trial was single blinded, which the label specifies as "video EEG interpreter blinded," so the EEG reader was kept unaware of the treatment ¹.

After the two weeks, 8 prednisone non-responders were given Acthar Gel and 7 responded; the 2 ACTH non-responders were given prednisone and 1 responded ¹. A supportive single-blind randomized trial compared a high dose for three weeks in 30 infants with a low dose for two weeks in 29 ¹. The label reports "nominal statistical superiority of the high dose treatment" for stopping spasms "but not for the resolution of hypsarrhythmia" ¹.

Studied in people for multiple sclerosis: the label says "controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis" ¹. It adds, in the same paragraph, that "there is no evidence that it affects the ultimate outcome or natural history of the disease" ¹.

A Cochrane review, a systematic review from the Cochrane network that pools the trials it finds by a set method, was published in 2000 ⁹. It pooled six randomized trials of corticosteroids or ACTH for acute exacerbations, each double-blind, so that neither patients nor clinicians knew the treatment, and placebo-controlled, against an inactive comparison ⁹. They enrolled 377 participants, 199 on treatment and 178 on placebo ⁹. Two of the trials, with 237 patients, tested ACTH, and four, with 140, tested methylprednisolone, a steroid ⁹.

Across the six, treatment "showed a protective effect against the disease getting worse or stable within the first five weeks" ⁹. The odds ratio was 0.37, with a 95 percent confidence interval of 0.24 to 0.57 ⁹.

An odds ratio below 1 means the treated group fared better; the interval is the range the true value most likely lies in. The effect looked somewhat larger for methylprednisolone, "but non significant" ⁹.

The reviewers wrote that "no data are available beyond one year of follow-up to indicate whether steroids or ACTH have any effect on long-term progression" ⁹. They also found that "weight gain and edema were significantly more frequent in the ACTH group than in controls" ⁹. They "found evidence favouring the corticosteroid MP," methylprednisolone, and said "data are insufficient to reliably estimate" its effect on new exacerbations and long-term disability ⁹.

A head-to-head trial, published in July 1989, randomized 61 patients in an acute relapse to high-dose intravenous methylprednisolone or intramuscular ACTH, double-blind ¹⁰. Both groups improved markedly, with "no difference between them in either the rate of recovery or the final outcome" ¹⁰.

For the other listed uses, the rheumatic, collagen, skin, allergic, eye, respiratory and kidney disorders, the Acthar Gel label cites no trial ¹. The Purified Cortrophin Gel label says corticotropin "should be administered for treatment only when the disease is intractable to more conventional therapy" and "should be adjunctive and not the sole therapy" ². None of the sources cited here tests corticotropin for weight loss, muscle or aging; one small registered trial tested it for fatigue in multiple sclerosis ⁵, ¹, ⁹, ¹⁰, ¹².

What are the side effects?

"The adverse effects of Acthar Gel are related primarily to its steroidogenic effects," the label says, meaning the effects of the cortisol it makes the body produce ¹. In infants treated for infantile spasms, the label tabulates reactions "from retrospective chart reviews and clinical trials" ¹.

In 122 infants on the recommended twice-daily regimen, infection was recorded in 20 percent, convulsion in 12, hypertension in 11, irritability in 7 and fever in 5 ¹. In 37 infants on a once-daily regimen, infection was recorded in 46 percent and a Cushingoid appearance, the look of too much cortisol, in 22 ¹. Hypertension and irritability were recorded in 19 percent each, diarrhea and acne in 14 each ¹. The label cautions that "the number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups" ¹.

Reports since approval come "from a population of uncertain size" ¹. Commonly reported ones include "injection site reaction, asthenic conditions (including fatigue, malaise, asthenia and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased" ¹. Others named include anaphylaxis, congestive heart failure, pancreatitis in adults, vertebral compression fractures in infants and "reversible brain shrinkage (usually secondary to hypertension)" in infants ¹.

The label's warnings run to thirteen. Treatment "can cause hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome" ¹. The HPA axis is the chain from the hypothalamus in the brain to the pituitary to the adrenal glands that controls cortisol, and suppression means the drug switches it off ¹. For Cushing's syndrome the label names "moon face, truncal obesity," stretch marks, easy bruising, "weight gain, muscle weakness, hyperglycemia, and hypertension" ¹.

After prolonged use the adrenal glands may not restart on their own, and stopping suddenly "may lead to adrenal insufficiency" ¹. "The recovery of the adrenal gland may take from days to months" ¹. The drug "may increase the risks related to infections with any pathogen" and "can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium" ¹.

It "can cause GI bleeding and gastric ulcer" ¹. Mood effects range "from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations" ¹. Prolonged use "may produce posterior subcapsular cataracts, glaucoma," may inhibit growth in children, and may lead "to the development of osteoporosis at any age" ¹.

"Acthar Gel is immunogenic," and a patient "may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity" ¹. "Hypersensitivity reactions including anaphylaxis and angioedema have been reported" ¹. The label says it "may cause fetal harm when administered to a pregnant woman," and there are no data on the drug in human milk ¹. Cancer studies "have not been conducted," and genetic damage and fertility have not been adequately evaluated or assessed ¹.

The label contraindicates Acthar Gel "for intravenous administration," "in infants under 2 years of age who have suspected congenital infections," and with live vaccines in patients on immunosuppressive doses ¹. It is also contraindicated "in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenocortical hyperfunction" ¹. The October 2026 revision added a contraindication for "a history of hypersensitivity reaction to corticotropin or any of the inactive ingredients of Acthar Gel" ¹, ¹¹, ⁶. Purified Cortrophin Gel's label lists most of the same contraindications, without the congenital-infection and live-vaccine bullets, and adds that "chronic administration of corticotropin may lead to adverse effects which are not reversible" ².

In sport

WADA, the World Anti-Doping Agency, names the class on its 2026 Prohibited List ¹³. Section S2.2.2 reads, in full: "Corticotrophins and their releasing factors, e.g. corticorelin and tetracosactide" ¹³. Corticotrophin is the list's spelling of corticotropin, and its index entry "Corticotrophins" points to the same section ¹³. Class S2, "Peptide hormones, growth factors, related substances, and mimetics," is "prohibited at all times (in- and out-of-competition)," and "all prohibited substances in this class are non-Specified Substances" ¹³. The list explains that Specified Substances are those "more likely to have been consumed or used by an Athlete for a purpose other than the enhancement of sport performance"; corticotrophins are not in that group ¹³.

What JumpstartMD offers

JumpstartMD does not prescribe corticotropin. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.