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Sensipar (CINACALCET)
Sensipar works by activating the calcium-sensing receptor, which helps regulate calcium levels in the blood.
Sensipar (CINACALCET) is a small molecule calcium-sensing receptor agonist developed by AMGEN, targeting the extracellular calcium-sensing receptor. It is FDA-approved for treating hypercalcemia due to primary hyperparathyroidism, secondary hyperparathyroidism in chronic renal failure patients on dialysis, and parathyroid carcinoma with hypercalcemia. Sensipar is commercially available, with 14 generic manufacturers, and remains under patent. Key safety considerations include monitoring of calcium levels and potential interactions with other medications. The drug has a half-life of 19.9 hours and 20% bioavailability.
At a glance
| Generic name | CINACALCET |
|---|---|
| Sponsor | Amgen |
| Drug class | Calcium-sensing Receptor Agonist |
| Target | Extracellular calcium-sensing receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Mechanism of Action. Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) is progressive disease, associated with increases in parathyroid hormone (PTH) levels and derangements in calcium and phosphorus metabolism. Increased PTH stimulates osteoclastic activity resulting in cortical bone resorption and marrow fibrosis. The goals of treatment of secondary hyperparathyroidism are to lower levels of PTH, calcium, and phosphorus in the blood, in order to prevent progressive bone disease and the systemic consequences of disordered mineral metabolism. In CKD patients on dialysis with uncontrolled secondary HPT, reductions in PTH are associated with favorable impact on bone-specific alkaline phosphatase (BALP), bone turnover and bone fibrosis. The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion. Sensipar(R) directly lowers PTH levels by increasing the sensitivity of the calcium-sensing
Approved indications
- Hypercalcemia due to Primary Hyperparathyroidism
- Hyperparathyroidism Secondary to Chronic Renal Failure with Dialysis
- Parathyroid Carcinoma with Hypercalcemia
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Myalgia
- Dizziness
- Hypertension
- Asthenia
- Anorexia
- Pain Chest, Non-Cardiac
- Access Infection
- Rash
- Hypersensitivity reactions
Drug interactions
- CYP2D6 Substrates
- erythromycin
- flecainide
- itraconazole
- ketoconazole
- posaconazole
- thioridazine
- vinblastine
Key clinical trials
- The Trial of SHR6508 in Secondary Hyperparathyroidism (PHASE3)
- Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism (PHASE3)
- Novel Combination Therapy for Osteoporosis in Men (PHASE4)
- Effect of Whole-body Vibration Training in Patients With Renal Dialysis (NA)
- Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
- DePTH: De-emphasize PTH (PHASE2)
- Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients (PHASE1,PHASE2)
- A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sensipar CI brief — competitive landscape report
- Sensipar updates RSS · CI watch RSS
- Amgen portfolio CI