Drug · Small Molecule
Cinacalcet
CI-DRUG-00000786Explore in graph →CHEMBL1201284 Approved
Regulatory
Approvals (9)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2017-05-23 (see label) | approved | May 23, 2017 | openfda |
| US FDA | — | Efficacy supplement 2014-11-21 (see label) | approved | Nov 21, 2014 | openfda |
| US FDA | — | Efficacy supplement 2011-02-25 (see label) | approved | Feb 25, 2011 | openfda |
| US FDA | — | Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. • 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. | approved | Mar 8, 2004 | openfda |
Data updated 12 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 0 | 0 | 2 | 6 | 9 | EU, US | Mar 8, 2004 | 2001-04 |
| Malignant Prostate Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | 2011-09 |
ComputedclinicaltrialsProvenance
- Source
- clinicaltrials
- Layer
- derived (computed by CancerIndex)
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (6)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03123406 | Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT(ACTIVE) | completed | Phase 4 | 750 | Kyowa Kirin China Pharmaceutical Co., Ltd.INDUSTRY | 1 | Apr 29, 2024 | clinicaltrials |
| NCT03027557 | Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.(DENOCINA) |