Sensipar

(Cinacalcet)

ApprovedSmall molecule

Cinacalcet is used to treat high calcium levels in the blood caused by overactive parathyroid glands in patients with kidney disease on dialysis, or in patients with parathyroid cancer.[2] Sensipar is currently approved and in use across 13 indications[4].[1]

Sensipar is one of 230 small molecule programs targeting Parathyroid Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

229

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Parathyroid DiseaseActive, not recruiting

Renal OsteodystrophyApproved

Memory ImpairmentApproved

Chronic Renal Failure SyndromeApproved

Bone DensityActive, not recruiting

Kidney TransplantActive, not recruiting

OsteoporosisActive, not recruiting

MaleCompleted

Secondary HyperparathyroidismTerminated

Primary HyperparathyroidismCompleted

Parathyroid DiseaseApproved

Active, not recruiting

Renal OsteodystrophyApproved

Approved

Memory ImpairmentApproved

Approved

Chronic Renal Failure SyndromeApproved

Approved

Bone DensityPreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

OsteoporosisApproved

Active, not recruiting

MaleApproved

Completed

Secondary HyperparathyroidismApproved

Terminated

Primary HyperparathyroidismApproved

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Sensipar

Amgen

Approved

3 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

PROCRIT

1 10

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Secondary Hyperparathyroidism

NCT07122401

Clinical

Trials by Indication[1]

Secondary Hyperparathyroidism11 trials

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Completed· Amgen logo

Amgen·Phase 3·NCT03299244·637 enrolled

A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

Completed· Astellas logo

Astellas·Phase 2·NCT02133404·62 enrolled

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Completed· Amgen logo

Amgen·Phase 3·NCT02341417·28 enrolled

Show 8 more trials

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Recruiting·SShaanxi Micot Pharmaceutical Technology Co., Ltd.·Phase 3·NCT07122401·424 enrolled

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

Completed· Amgen logo

Amgen·Phase 3·NCT00117052·673 enrolled

A Study of SHR6508 in Secondary Hyperparathyroidism

Unknown status· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 2·NCT05663411·75 enrolled

Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation

Completed·JJosep m Cruzado·Phase 4·NCT01178450·30 enrolled

Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Terminated·PPapageorgiou General Hospital·Phase 4·NCT00446329·15 enrolled

Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Completed· Amgen logo

Amgen·Phase 2·NCT00042432·54 enrolled

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Completed· Amgen logo

Amgen·Phase 4·NCT01181531·312 enrolled

Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

Completed·—·Phase 4·NCT01143987·44 enrolled

Primary Hyperparathyroidism10 trials

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.

Completed·PPeter Vestergaard·Phase 3·NCT03027557·46 enrolled

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Completed· Amgen logo

Amgen·Phase 3·NCT00975221·67 enrolled

Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

Completed·—·Phase 2/3·NCT02525796·69 enrolled

Show 7 more trials

A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

Completed· Amgen logo

Amgen·Phase 2·NCT00936650·78 enrolled

Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?

Completed·KKarolinska University Hospital·N/A·NCT02227264·110 enrolled

Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)

Completed· Amgen logo

Amgen·Phase 2·NCT03776058·10 enrolled

Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism

Completed· Amgen logo

Amgen·Phase 2·NCT03774771·48 enrolled

Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism

Completed·IIstituto Auxologico Italiano·Phase 4·NCT02417389·22 enrolled

A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism

Completed· Amgen logo

Amgen·Phase 2·NCT00936988·45 enrolled

PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

Completed· Amgen logo

Amgen··NCT00928408·305 enrolled

Chronic Kidney Disease3 trials

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

Completed· Amgen logo

Amgen·Phase 1·NCT01290029·14 enrolled

Pediatric Chronic Kidney Disease Safety and Efficacy

Terminated· Amgen logo

Amgen·Phase 3·NCT01277510·43 enrolled

ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Completed· Amgen logo

Amgen·Phase 4·NCT00379899·360 enrolled

End Stage Renal Disease (ESRD)2 trials

Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)

Completed· Amgen logo

Amgen·Phase 2·NCT00113945·360 enrolled

A Research Study for Patients With End-Stage Renal Disease (ESRD)

Completed· Amgen logo

Amgen·Phase 4·NCT00110890·552 enrolled

Peritoneal Dialysis2 trials

Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

Completed·SSeoul National University Hospital·Phase 4·NCT01101113·66 enrolled

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Completed·TThe University of Hong Kong·Phase 4·NCT01447368·67 enrolled

18 more indications

Hypophosphatemic Rickets2 trials

Calcimimetics in Hypophosphatemic Rickets

Withdrawn·—·N/A·NCT00844740

Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets

Completed·—·Phase 1·NCT00195936·8 enrolled

Kidney Disease2 trials

Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels

Completed· Amgen logo

Amgen·Phase 2·NCT00113958

A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)

Completed· Amgen logo

Amgen·Phase 4·NCT00431496·71 enrolled

NAC1 trial

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Completed· Amgen logo

Amgen·Phase 3·NCT01896232·683 enrolled

Effectiveness1 trial

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

Completed·AAbbott·Phase 4·NCT00977080·272 enrolled

Nicotinamide1 trial

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Terminated·—·Phase 3·NCT01011699·176 enrolled

Gastric Acid1 trial

The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

Completed·TTufts University·N/A·NCT00336739·17 enrolled

Ventricular Function1 trial

Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

Completed·LLaval University·Phase 4·NCT01250405·23 enrolled

Cardiovascular Events1 trial

E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

Completed· Amgen logo

Amgen·Phase 3·NCT00345839·3,883 enrolled

Renal Osteodystrophy1 trial

Renal Osteodystrophy: An Individual Management Approach

Completed·—·N/A·NCT02440581·141 enrolled

Cognitive Functions1 trial

Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Completed·PProf. Dominique de Quervain, MD·Phase 2·NCT01599962·40 enrolled

ESS1 trial

Evaluation of a Cincalcet Suppression Test

Completed·UUniversity Hospital, Rouen·Phase 4·NCT01103206·36 enrolled

Dialysis1 trial

20070360 Incident Dialysis

Completed· Amgen logo

Amgen·Phase 4·NCT00803712·313 enrolled

Hyperparathyroidism1 trial

Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

Completed· Amgen logo

Amgen·Phase 3·NCT00975000·114 enrolled

Kidney Transplant1 trial

Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

Terminated·MMontefiore Medical Center·N/A·NCT01011114·40 enrolled

Interaction1 trial

Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System

Completed·—·N/A·NCT01519037·18 enrolled

Bone Density1 trial

Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment

Completed·MMin-Sheng General Hospital·N/A·NCT04637360·40 enrolled

Growth1 trial

Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis

Completed·TTanta University·Phase 4·NCT05926570·35 enrolled

Male1 trial

Novel Combination Therapy for Osteoporosis in Men

Completed·VVA Office of Research and Development·Approved·NCT03994172·40 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 8, 2004

SENSIPAR

NDA NDA021688

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Cinacalcet. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sensipar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cinacalcet compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cinacalcet. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021688). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sensipar. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Calcium Sensing Receptor Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Amgen

Patent Landscape[6]

Patent Cliff

Sep 22, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7829595Sep 22, 2026

9375405Sep 22, 2026

Sensipar

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Secondary Hyperparathyroidism11 trials

Primary Hyperparathyroidism10 trials

Chronic Kidney Disease3 trials

End Stage Renal Disease (ESRD)2 trials

Peritoneal Dialysis2 trials

Hypophosphatemic Rickets2 trials

Kidney Disease2 trials

NAC1 trial

Effectiveness1 trial

Nicotinamide1 trial

Gastric Acid1 trial

Ventricular Function1 trial

Cardiovascular Events1 trial

Renal Osteodystrophy1 trial

Cognitive Functions1 trial

ESS1 trial

Dialysis1 trial

Hyperparathyroidism1 trial

Kidney Transplant1 trial

Interaction1 trial

Bone Density1 trial

Growth1 trial

Male1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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