Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Cosyntropin (Cortrosyn, tetracosactide, ACTH 1-24): what the evidence says
At a glance
What it is: a synthetic peptide made of the first 24 of the 39 amino acids of human ACTH, which carries ACTH's full cortisol-stimulating activity. Approved as Cortrosyn (Apr 1970) as a diagnostic agent: blood cortisol is measured before and after a dose to screen for adrenal insufficiency. Synacthen is a brand used outside the US. R1, R2, R3
What the evidence says: Human a meta-analysis found high- and low-dose ACTH stimulation tests had similar accuracy; both are good at confirming secondary adrenal insufficiency but can miss it, and confidence in the estimates was low to moderate. R4
Biggest risks: allergic reactions including anaphylaxis; certain medicines and conditions that change cortisol-binding protein can make results inaccurate. Prohibited in sport. R3, R5
Rating
| Human Human evidence | Moderate: diagnostic-accuracy meta-analysis R4 |
| 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 R6, R7, R8 · prohibited at all times (WADA S2.2.2) R5 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Testing for adrenal insufficiency: Moderate (diagnostic-accuracy meta-analysis; good at ruling in, weaker at ruling out) · Treatment of any condition: not a treatment in the US
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: pooled diagnostic studies with varied cortisol cut-offs; the test is a screen and is used with other tests.
What is it?
Related pages: corticotropin-acth.
Does it work?
- Human Secondary adrenal insufficiency (30 studies, 1,437 people): positive likelihood ratios 9.1 (high dose) and 5.9 (low dose) in adults; negative likelihood ratios weaker. R4
- Human Primary adrenal insufficiency (5 studies, 100 patients): sensitivity 92% for the high-dose test. R4
Is it safe?
- Warnings: hypersensitivity including anaphylaxis; diagnostic inaccuracy with some medicines. R3
- Most common: anaphylactic reaction, slow or fast heart rate, high blood pressure, swelling, rash. R3
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 diagnostic (Cortrosyn; generic cosyntropin). R1, R2
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R6, R7, R8
- Sport: prohibited at all times; WADA names tetracosactide (cosyntropin) under S2.2.2. R5
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Ospina 2016 meta-analysis | 30 studies (secondary AI) + 5 (primary AI) | IV or IM | 250 µg (high dose) vs 1 µg (low dose) | Single test | Similar accuracy; good to rule in, weaker to rule out | PMID 26649617 |
| Cortrosyn label | Adults and children | IV or IM | Per label | Single test | Approved for adrenal insufficiency screening | R3 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Cortrosyn (cosyntropin), application NDA016750 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA016750
- R2 Drugs@FDA, Cosyntropin (Sandoz), application ANDA202147 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=ANDA202147
- R3 Cortrosyn prescribing information, label published Feb 7, 2025 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=746856e9-3930-4f6a-b8e6-a03845d6dd0b
- R4 Ospina NS, et al. J Clin Endocrinol Metab. 2016. PMID 26649617
- R5 WADA. The 2026 Prohibited List, S2.2.2, Corticotrophins and their releasing factors, naming tetracosactide. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R8 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 Cosyntropin (Cortrosyn, tetracosactide, ACTH 1-24). 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).