TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

APREMILAST

APREMILAST
Approved 2021-02-17
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2021-02-17
Routes
ORAL
Dosage Forms
TABLET

Companies

AMNEAL MACLEODS PHARMS LTD Aurobindo Pharma UNICHEM GLENMARK PHARMS LTD MSN Teva Dr. Reddy's ALKEM LABS LTD SHILPA ANNORA MANKIND PHARMA TORRENT ZYDUS PHARMS
Active Ingredient: APREMILAST

APREMILAST Approval History

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What APREMILAST Treats

13 FDA approvals

Originally approved for its first indication in 2021 . Covers 13 distinct patient populations.

  • Other (13)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

APREMILAST FDA Label Details

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Data Sources

FDA Approval: ANDA211782 → Trials: ClinicalTrials.gov →

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