PeptideTrace
ApprovedSynthetic ACTH Fragment

Cosyntropin

Cortrosyn

A

Evidence Grade A — Regulatory approved. 655 published studies. 38 registered clinical trials.

38 trials655 studiesUSEUCA

Licensed Indications

  • Adrenocortical Insufficiency Screening

User Experience Reports

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Overview

Cosyntropin (sold as Cortrosyn) is not a treatment — it is a diagnostic tool. It is the standard reagent used in the ACTH stimulation test, one of the most commonly performed hormone tests, which checks whether the adrenal glands can produce cortisol normally. Doctors use it to diagnose adrenal insufficiency and to evaluate patients who have been on long-term steroid medications.

Research Activity

655studies
Human 504
Animal 51
In-vitro 7
Reviews 62

655 published studies: 504 human, 51 animal, 7 in-vitro, 62 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

Cosyntropin is marketed as Cortrosyn (approved approximately 1970). It is the standard tool for the ACTH stimulation test, one of the most commonly performed endocrine diagnostic procedures. A standard 250 mcg dose is given by injection, with blood cortisol measured at 30 and 60 minutes. A normal response is typically defined as a stimulated cortisol level above 18–20 mcg/dL.

A low-dose (1 mcg) protocol has been studied as a potentially more sensitive test for detecting partial adrenal insufficiency, though the standard 250 mcg dose remains the established clinical practice. Cosyntropin is one of the few peptide compounds used purely for diagnosis rather than treatment.

Mechanism of Action

Cosyntropin mimics the body's natural ACTH by stimulating the adrenal glands to produce cortisol. In a healthy person, a dose of cosyntropin triggers a rapid and substantial rise in cortisol within 30–60 minutes. If the adrenal glands fail to respond adequately (cortisol does not rise above the expected threshold), this indicates adrenal insufficiency — the adrenal glands cannot produce enough cortisol, whether due to primary adrenal failure or prolonged suppression from steroid medications.

Research Summary

Cosyntropin's clinical utility is well established and uncontroversial. The standard test protocol involves injecting 250 mcg and measuring blood cortisol at 30 and 60 minutes — a normal response confirms the adrenal glands are working. The main ongoing clinical discussion concerns what cortisol level counts as a "pass," since newer laboratory methods produce different numbers than older platforms, leading some guidelines to suggest lower thresholds. A low-dose version of the test (1 mcg instead of 250 mcg) has been studied as potentially more sensitive for detecting partial adrenal problems, but the standard dose remains the established practice. No significant research programmes are investigating cosyntropin itself — it is a mature diagnostic tool.

Clinical Trials

NCT06190158Early Phase IRecruiting

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Brigham and Women's HospitalEndpoint: The magnitude of non-suppressible and renin-independent aldosterone production following saline suppressionCompletion: 2029-07-31
NCT05149638N/ARecruiting

Updated Diagnostic Cortisol Values for Adrenal Insufficiency

Montefiore Medical CenterEndpoint: Cortisol threshold with cosyntropin stimulation testCompletion: 2027-12-01
NCT04546126Early Phase IRecruiting

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

Benjamin VigliantiEndpoint: Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentationCompletion: 2026-12-01
NCT04642391N/ACompleted

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

University of VirginiaEndpoint: RAI prevalenceCompletion: 2024-06-30
NCT04461535N/ACompleted

Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)

Chongqing Medical UniversityEndpoint: Compare the proportion of surgically treated patients with complete biochemical remission in the overall cohort between two groupsCompletion: 2023-02-20
View all 38 trials on ClinicalTrials.gov →

Regulatory Timeline

1970
Regulatory

FDA ORIG 1

1982
Regulatory

FDA SUPPL 2

1982
Regulatory

FDA SUPPL 3

1986
Regulatory

FDA SUPPL 4

1987
Regulatory

FDA SUPPL 5

1987
Regulatory

FDA SUPPL 7

1987
Regulatory

FDA SUPPL 6

1988
Regulatory

FDA SUPPL 8

1988
Regulatory

FDA SUPPL 9

1989
Regulatory

FDA SUPPL 10

1994
Regulatory

FDA SUPPL 12

1997
Regulatory

FDA SUPPL 14

1997
Regulatory

FDA SUPPL 13

1998
Regulatory

FDA SUPPL 15

1999
Regulatory

FDA SUPPL 16

2000
Regulatory

FDA SUPPL 17

2002
Regulatory

FDA SUPPL 18

2012
Regulatory

FDA ORIG 1

2014
Regulatory

FDA SUPPL 28

2021
Regulatory

FDA SUPPL 32

2023
Regulatory

FDA SUPPL 33

2024
Regulatory

FDA SUPPL 17

2024
Regulatory

FDA SUPPL 18

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.