Corticotropin
Melanocortin / ACTH
Also ACTH, Acthar Gel, Acthar, H.P. Acthar Gel, Adrenocorticotropic hormone, Adrenocorticotropin
- Evidence
- BSome human evidence
- FDA status
- FDA approvedas of 2026-10-27
- Route
- Injection
- Studies cited
- 1 human0 animal or cell
It is an old hormone injection used for a rare seizure illness in babies and for flare-ups of multiple sclerosis. A small trial in 29 babies backs the baby use; most other uses rest on old reports.
Sold for
Corticotropin is less a wellness peptide than a controversy over price: a 1952 hormone extract that became one of the most expensive drugs in the United States while being prescribed for conditions where cheap steroids are the usual choice.
Studies say
In infantile spasms, a small randomized trial found high-dose corticotropin stopped spasms and normalized the EEG in 87% of infants against 29% on prednisone, which supports that use; for most other labeled conditions the evidence is old and uncontrolled.
Why grade B. The use corticotropin is best known for today, infantile spasms, is supported by randomized trials, but they are small: the trial in the citations randomized 29 infants. Most of the other labeled indications were approved in the 1950s on uncontrolled experience and the label itself says controlled trials in multiple sclerosis showed faster recovery from attacks without changing the disease course. That earns a B and not an A. 13
FDA. Corticotropin is FDA-approved as Acthar Gel (repository corticotropin injection), first approved in 1952. The current label lists infantile spasms in children under two, acute exacerbations of multiple sclerosis in adults, and a set of older indications in rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory and edematous conditions. ANI Pharmaceuticals' Purified Cortrophin Gel, approved in 1954, is a second FDA-approved corticotropin product.
Written from 4 cited sources. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Seizures in babies, multiple sclerosis flare-ups
- Can a US doctor prescribe it?
- Yes. Acthar Gel is FDA approved for seizures in babies under two and multiple sclerosis flare-ups, and a second brand is approved too.
- Properly tested in people?
- Partly: a small trial of 29 babies backs the main use; most other uses were never tested well.
Evidence checklist
- Randomised controlled trial Blinded trial vs prednisone in infantsyes
- Human study over 100 people Infant trial had 29 participantsno
- More than one research group No other groups' trials describedno information
- Clinical outcomes, not surrogate markers Spasm and EEG response measuredyes
- Human safety data beyond case reports Steroid-type effects well documentedyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Corticotropin is adrenocorticotropic hormone (ACTH). This peptide has 39 amino acids. The pituitary releases it to tell the adrenal glands to make cortisol. Acthar Gel is a purified extract of ACTH from pig pituitaries. It is mixed into gelatin so it releases slowly after injection into muscle or under the skin. 2
It has been on the US market since 1952. The FDA formally added the infantile spasms approved use in 2010. The label was last revised in October 2026. ANI Pharmaceuticals' Purified Cortrophin Gel, approved in 1954, is a second FDA-approved corticotropin product. 324
How it works
ACTH binds the melanocortin-2 receptor on the adrenal cortex and drives cortisol production. So most of its effects are those of a corticosteroid, such as less inflammation and less immune activity. It also binds other melanocortin receptors in the brain, immune cells and elsewhere. The manufacturer suggests this may set it apart from prednisone. In infantile spasms, the mechanism is not known. One idea is that ACTH suppresses corticotropin-releasing hormone. This brain peptide may promote seizures in infants. 21
What human research shows
Baram and colleagues randomized 29 infants with infantile spasms. The infants also showed the chaotic EEG pattern called hypsarrhythmia. They got two weeks of high-dose corticotropin or prednisone. A response meant the spasms stopped and the EEG cleared. An investigator who did not know the treatment judged this. Thirteen of 15 infants on corticotropin responded (87%). Only 4 of 14 on prednisone did (29%). The authors note that earlier blinded studies found low-dose ACTH no better than prednisone. 1
For multiple sclerosis, the label says controlled trials showed corticotropin speeds recovery from acute flare-ups. But it says there is no evidence the drug changes the final outcome or the course of the disease. 3
| Study | Model | Finding |
|---|---|---|
| Baram 1996, high-dose ACTH vs prednisone | Humans, n=29 infants with infantile spasms, randomized, single-blinded outcome assessment | 87% response (spasms stopped and EEG cleared) with corticotropin versus 29% with prednisone. 1 |
| Acthar Gel prescribing information | Regulatory summary of clinical trials and post-marketing experience | Approved for infantile spasms and MS exacerbations among other indications; steroid-type adverse effects. 3 |
Safety
Corticotropin raises cortisol, so its side effects match those of high-dose steroids. They include fluid retention, high blood pressure, higher blood sugar, mood and behaviour changes, and weight gain. They also include weaker immunity with more infections, stomach ulcers and bone loss. Stopping the drug can leave the adrenal glands suppressed. In infants, the main concerns are irritability, infection and high blood pressure. The authors of the 1996 trial call the side effects of high-dose ACTH severe and dose-dependent. The label advises tapering instead of stopping at once. It also lists live vaccines as off limits during treatment. 31
The label also warns of allergic reactions, since the product is an extract of pig protein. Long-term data comparing it with lab-made corticosteroids in adults are not available. 3
Questions for your clinician
- Why is this chosen over a steroid for my condition, given the small trial evidence?
- How will side effects like blood pressure and infection risk be monitored?
- What happens when treatment stops, and how is it tapered?
Questions people ask
Is corticotropin FDA-approved?
Yes. Acthar Gel has been approved since 1952. The infantile spasms use was formally approved in 2010. The label covers a long list of inflammatory conditions from the era before lab-made steroids. A second product, Purified Cortrophin Gel, has been approved since 1954. 324
How is corticotropin different from prednisone?
Prednisone is a lab-made steroid that acts directly. Corticotropin is the pituitary hormone that makes the adrenal glands produce the body's own cortisol. It also binds melanocortin receptors outside the adrenal gland. In a trial of 29 infants with infantile spasms, high-dose corticotropin did better than prednisone. 12
What unwanted effects come with corticotropin treatment?
Mostly the effects of high cortisol. These are fluid retention, high blood pressure, high blood sugar, mood change, infection risk and bone loss. Adrenal suppression can follow when the drug stops. Doctors watch infants for irritability, infection and high blood pressure. Allergic reactions to the pig-derived protein are also possible. 31
Is it the same as cosyntropin?
No. Cosyntropin is a lab-made fragment of ACTH (the first 24 amino acids). Doctors give it once as a test of adrenal function. Corticotropin is the full natural hormone in a slow-release gel. It is used as a treatment over days or weeks. 2
Citations
- Baram 1996, Pediatrics: high-dose corticotropin versus prednisone for infantile spasms, randomized blinded study pubmed.ncbi.nlm.nih.gov
- Acthar Gel prescribing information (manufacturer) acthar.com
- FDA label, 2021: Acthar Gel (repository corticotropin injection) accessdata.fda.gov
- Drugs@FDA: Acthar Gel (NDA 008372) approval record accessdata.fda.gov