Cinacalcet

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
The Trial of SHR6508 in Secondary Hyperparathyroidism	2024/05/30	NCT06434961	Phase 3	Active, not recruiting	Shanghai Hengrui Pharmaceutical Co., Ltd.
Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis	2023/07/03	NCT05926570	Phase 4	Completed	Tanta University
A Study of SHR6508 in Secondary Hyperparathyroidism	2022/12/23	NCT05663411	Phase 2	Active, not recruiting	Shanghai Hengrui Pharmaceutical Co., Ltd.
Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment	2020/11/19	NCT04637360	Not Applicable	Completed	Min-Sheng General Hospital
Novel Combination Therapy for Osteoporosis in Men	2019/06/21	NCT03994172	Phase 4	Active, not recruiting	VA Office of Research and Development
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia	2019/01/30	NCT03822507	Phase 3	Completed	Kyowa Kirin Co., Ltd.
Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)	2018/12/14	NCT03776058	Phase 2	Completed	Amgen
Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism	2018/12/13	NCT03774771	Phase 2	Completed	Amgen
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)	2017/10/03	NCT03299244	Phase 3	Completed	Amgen
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT	2017/04/21	NCT03123406	Phase 4	Completed	Kyowa Kirin China Pharmaceutical Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CINACALCET	Accord Healthcare, Inc.	16729-441	ORAL	60 mg in 1 1	11/23/2023
Cinacalcet	Sun Pharmaceutical Industries, Inc.	47335-379	ORAL	30 mg in 1 1	12/20/2021
cinacalcet hydrochloride	Slate Run Pharmaceuticals	70436-007	ORAL	30 mg in 1 1	3/5/2019
Sensipar	Amgen Inc	55513-073	ORAL	30 mg in 1 1	12/5/2019
Cinacalcet	Strides Pharma Inc.	42543-962	ORAL	60 mg in 1 1	1/23/2023
Sensipar	State of Florida DOH Central Pharmacy	53808-0577	ORAL	30 mg in 1 1	6/8/2010
Cinacalcet	Dr. Reddys Laboratories Inc	43598-368	ORAL	60 mg in 1 1	11/20/2021
Cinacalcet	Bryant Ranch Prepack	72162-1844	ORAL	60 mg in 1 1	3/8/2024
Sensipar	Amgen Inc	55513-074	ORAL	60 mg in 1 1	12/5/2019
Cinacalcet	AvKARE	42291-460	ORAL	60 mg in 1 1	1/9/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Cinacalcet Accordpharma	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	4/3/2020
Cinacalcet Mylan	Mylan Pharmaceuticals Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland	Authorised	11/19/2015
Mimpara	Amgen Europe B.V.,Minervum 7061,NL-4817 ZK Breda,The Netherlands	Authorised	10/22/2004

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
REGPARA TABLETS 25 MG	Ohara Pharmaceutical Co., Ltd (Kami Factory)	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	Alphapharm Pty Ltd	Medicine	A	11/3/2020
APO-CINACALCET cinacalcet (as hydrochloride) 30 mg tablets blister pack	240299	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/30/2016
GenRx CINACALCET cinacalcet (as hydrochloride) 90 mg tablets blister pack	240296	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/30/2016
CIPCALCET cinacalcet (as hydrochloride) 60 mg tablet bottle	372682	Cipla Australia Pty Ltd	Medicine	A	2/7/2023
APO-CINACALCET cinacalcet (as hydrochloride) 90 mg tablets blister pack	240294	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/30/2016
CINACALCET VIATRIS cinacalcet 90 mg tablet blister pack	289381	Alphapharm Pty Ltd	Medicine	A	11/3/2020
CIPCALCET cinacalcet (as hydrochloride) 90 mg tablet bottle	372683	Cipla Australia Pty Ltd	Medicine	A	2/7/2023
CIPLA CINACALCET cinacalcet (as hydrochloride) 90 mg tablet bottle	372676	Cipla Australia Pty Ltd	Medicine	A	2/7/2023
CINACALCET APOTEX cinacalcet (as hydrochloride) 90 mg tablets blister pack	240293	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/30/2016
CINACALCET APOTEX cinacalcet (as hydrochloride) 60 mg tablets blister pack	240297	Arrotex Pharmaceuticals Pty Ltd	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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