What is ACTH used for?

ACTH is an FDA-approved medication. See full prescribing information for approved uses.

Is ACTH FDA approved?

Yes, ACTH is FDA approved (first approved 1952-03-14) and manufactured by PARKEDALE.

ACTH is manufactured by PARKEDALE.

Data updated: Mar 10, 2026

ACTH

CORTICOTROPIN

Approved 1952-03-14

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1952-03-14
Routes: INJECTION
Dosage Forms: INJECTABLE

Companies

PARKEDALE

Active Ingredient: CORTICOTROPIN

ACTH Approval History

Loading approval history...

What ACTH Treats

1 FDA approvals

Originally approved for its first indication in 1952 .

Other (1)

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ACTH FDA Label Details

Pro

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: NDA008317 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.