Data updated: Mar 10, 2026
PRUCALOPRIDE SUCCINATE
PRUCALOPRIDE SUCCINATE
Approved 2024-12-26
5
Indications
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-12-26
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TORRENT APPCO Hikma SPECGX LLC AJANTA PHARMA LTD ZYDUS LIFESCIENCES NOVITIUM PHARMA ANNORA PHARMA Lupin Apotex MSN AMNEAL ALKEM LABS LTD ZENARA H2-PHARMA Teva SOMERSET THERAP
Active Ingredient: PRUCALOPRIDE SUCCINATE
Website: ↗
PRUCALOPRIDE SUCCINATE Approval History
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What PRUCALOPRIDE SUCCINATE Treats
5 FDA approvalsOriginally approved for its first indication in 2024 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Dec 2024)Letter
- • Approved indication (Jun 2025) New
- • Approved indication (Aug 2025) New
- • Approved indication (Jan 2026) New
- • Approved indication (Feb 2026) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
PRUCALOPRIDE SUCCINATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.