Overview
Cinacalcet is a calcimimetic sold by Amgen under the trade name Sensipar® in North America and Australia and as Mimpara® in Europe. It is used to treat hyperparathyroidism due to parathyroid tumours or renal failure.
Indication
For the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease who are on hemodialysis or peritoneal dialysis. Also for the treatment of hypercalcemia in patients with parathyroid carcinoma.
Associated Conditions
- Hypercalcemia
- Secondary Hyperparathyroidism (SHPT)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/05/30 | Phase 3 | Active, not recruiting | |||
2023/07/03 | Phase 4 | Completed | |||
2022/12/23 | Phase 2 | Active, not recruiting | |||
2020/11/19 | Not Applicable | Completed | |||
2019/06/21 | Phase 4 | Active, not recruiting | |||
2019/01/30 | Phase 3 | Completed | |||
2018/12/14 | Phase 2 | Completed | |||
2018/12/13 | Phase 2 | Completed | |||
2017/10/03 | Phase 3 | Completed | |||
2017/04/21 | Phase 4 | Completed | Kyowa Kirin China Pharmaceutical Co., Ltd. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Accord Healthcare, Inc. | 16729-441 | ORAL | 60 mg in 1 1 | 11/23/2023 | |
Sun Pharmaceutical Industries, Inc. | 47335-379 | ORAL | 30 mg in 1 1 | 12/20/2021 | |
Slate Run Pharmaceuticals | 70436-007 | ORAL | 30 mg in 1 1 | 3/5/2019 | |
Amgen Inc | 55513-073 | ORAL | 30 mg in 1 1 | 12/5/2019 | |
Strides Pharma Inc. | 42543-962 | ORAL | 60 mg in 1 1 | 1/23/2023 | |
State of Florida DOH Central Pharmacy | 53808-0577 | ORAL | 30 mg in 1 1 | 6/8/2010 | |
Dr. Reddys Laboratories Inc | 43598-368 | ORAL | 60 mg in 1 1 | 11/20/2021 | |
Bryant Ranch Prepack | 72162-1844 | ORAL | 60 mg in 1 1 | 3/8/2024 | |
Amgen Inc | 55513-074 | ORAL | 60 mg in 1 1 | 12/5/2019 | |
AvKARE | 42291-460 | ORAL | 60 mg in 1 1 | 1/9/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/3/2020 | ||
Authorised | 11/19/2015 | ||
Authorised | 10/22/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
REGPARA TABLETS 25 MG | SIN13993P | TABLET, FILM COATED | 25 mg | 8/2/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CINACALCET VIATRIS cinacalcet 30 mg tablet blister pack | 289379 | Medicine | A | 11/3/2020 | |
APO-CINACALCET cinacalcet (as hydrochloride) 30 mg tablets blister pack | 240299 | Medicine | A | 5/30/2016 | |
GenRx CINACALCET cinacalcet (as hydrochloride) 90 mg tablets blister pack | 240296 | Medicine | A | 5/30/2016 | |
CIPCALCET cinacalcet (as hydrochloride) 60 mg tablet bottle | 372682 | Medicine | A | 2/7/2023 | |
APO-CINACALCET cinacalcet (as hydrochloride) 90 mg tablets blister pack | 240294 | Medicine | A | 5/30/2016 | |
CINACALCET VIATRIS cinacalcet 90 mg tablet blister pack | 289381 | Medicine | A | 11/3/2020 | |
CIPCALCET cinacalcet (as hydrochloride) 90 mg tablet bottle | 372683 | Medicine | A | 2/7/2023 | |
CIPLA CINACALCET cinacalcet (as hydrochloride) 90 mg tablet bottle | 372676 | Medicine | A | 2/7/2023 | |
CINACALCET APOTEX cinacalcet (as hydrochloride) 90 mg tablets blister pack | 240293 | Medicine | A | 5/30/2016 | |
CINACALCET APOTEX cinacalcet (as hydrochloride) 60 mg tablets blister pack | 240297 | Medicine | A | 5/30/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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