CINACALCET HYDROCHLORIDE
Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. Studies ] . Studies ] . Studies ] .
Details
- Status
- Prescription
- First Approved
- 2018-03-08
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
CINACALCET HYDROCHLORIDE 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)
- • 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)
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03822507 | 7580-201 | Ph 3 | completed | Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia |
| NCT01439867 results posted | 20110100 2011-004618-40 | Ph 2 | terminated | Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism |
| NCT01054079 results posted | IRB00009741 NCI-2009-01514, CCCWFU 98309 | Ph 2 | completed | Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. 1.1 Secondary Hyperparathyroidism Cinacalcet table...
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Full clinical data, patents, trials, and competitive landscape for cinacalcet hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.