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Cinacalcet

Generic Name
Cinacalcet
Brand Names
Mimpara, Sensipar, Cinacalcet Mylan, Cinacalcet Accordpharma, Cinacalcet Viatris (previously Cinacalcet Mylan)
Drug Type
Small Molecule
Chemical Formula
C22H22F3N
CAS Number
226256-56-0
Unique Ingredient Identifier
UAZ6V7728S

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

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.

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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