TheraRadar
Data updated: Nov 8, 2026

H.P. ACTHAR GEL (repository corticotropin) · QUESTCOR PHARMA

Trial Activity: Mature
Immunology Approved 2010-10-15
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
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Development Insights

University of Maryland, Baltimore conducting 1 trials (17%)
7 indications explored (Moderate)
→ cns sarcoidosis (1 trials)
→ dermatomyositis (1 trials)
→ juvenile dermatomyositis (1 trials)
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-10-15
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

QUESTCOR PHARMA
Active Ingredient: REPOSITORY CORTICOTROPIN

H.P. ACTHAR GEL Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2010 to 2010
Oct 2010 ORIGINAL
Update · Type 6 - New Indication (no longer used)
FDA Letter Label

What H.P. ACTHAR GEL Treats

1 FDA approvals

Originally approved for its first indication in 2010 .

  • Other (1)
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT02298491 results posted HP-00062490 Ph 4 completed Treatment of CNS Sarcoidosis With H.P. Acthar Gel
NCT02245841 results posted 14-1015 Ph 4 completed Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
NCT01813591 ACTHAR Ph 2 completed A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines
NCT01155141 results posted SU-08182009-3600 Ph 4 completed Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
NCT01769937 ACTH 11191966 Ph 4 completed Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

H.P. ACTHAR GEL FDA Label Details

This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →

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Data Sources

FDA Approval: NDA022432 → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment