Data updated: Mar 10, 2026
CINACALCET HYDROCHLORIDE
CINACALCET HYDROCHLORIDE
Approved 2018-03-08
13
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-03-08
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
RISING Aurobindo Pharma WATSON LABS TEVA Teva ZYDUS PHARMS USA INC HETERO LABS LTD V PIRAMAL Lupin STEVENS J Dr. Reddy's Cipla ALKEM LABS LTD STRIDES PHARMA ACCORD HLTHCARE Sun Pharma CHARTWELL RX
Active Ingredient: CINACALCET HYDROCHLORIDE
Website: ↗
CINACALCET HYDROCHLORIDE Approval History
Loading approval history...
What CINACALCET HYDROCHLORIDE Treats
13 FDA approvalsOriginally approved for its first indication in 2018 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Mar 2018)Letter
- • Approved indication (Apr 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Dec 2018)
- • Approved indication (May 2019)
- • Approved indication (Jun 2019)
- • Approved indication (May 2020)
- • Approved indication (May 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Dec 2021)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
CINACALCET HYDROCHLORIDE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.