Data updated: Mar 10, 2026
SITAGLIPTIN PHOSPHATE
SITAGLIPTIN PHOSPHATE
Approved 2025-12-29
3
Indications
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2025-12-29
- Routes
- ORAL, FILM COATED
- Dosage Forms
- TABLET
Companies
SUN PHARMA GLOBAL MACLEODS PHARMS LTD Viatris ALKEM LABS LTD Novartis AJANTA PHARMA LTD WATSON LABS INC UNICHEM LABS LTD Apotex Teva ZYDUS PHARMS USA INC Dr. Reddy's
Active Ingredient: SITAGLIPTIN PHOSPHATE
Website: ↗
SITAGLIPTIN PHOSPHATE Approval History
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What SITAGLIPTIN PHOSPHATE Treats
3 FDA approvalsOriginally approved for its first indication in 2025 . Covers 3 distinct patient populations.
- Other (3)
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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.
SITAGLIPTIN PHOSPHATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.