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cinacalcet

Trade name: sensipar

Small moleculeapprovedOrphan Drug FDA

Approved

Mar 8, 2004

Cinacalcet is a positive allosteric modulator of calcium sensing receptor. The drug is approved by FDA (Sensipar trade name) and used for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis; hypercalcemia in adult patients with parathyroid carcinoma; hypercalcemia in adult patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. — NCATS

Clinical trial activity

73 trials · 61 clinical orgs · 21 marketing orgs

Phase 1
3
Phase 2
36
Phase 3
21
Phase 4
22

Earliest trial started Sep 29, 1998 (NCT03774771)

Timeline

1990s

  1. Jan 1, 1998

    Amgen — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Amgen — Earliest Phase 3 Sponsor(trial)

  2. May 12, 2003

    Orphan Drug Designation

  3. Mar 8, 2004

    Amgen — Earliest FDA Approval

  4. Mar 8, 2004

    Amgen — NDA Organization

  5. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. May 13, 2010

    Barr Laboratories — Marketing Organization

  2. Mar 8, 2018

    Aurobindo Pharma — Marketing Organization

  3. Mar 8, 2018

    Cipla — Marketing Organization

  4. Apr 27, 2018

    Alkem Labs Ltd — Marketing Organization

  5. Apr 30, 2018

    Strides Pharma Science — Marketing Organization

  6. Aug 1, 2018

    Piramal — Marketing Organization

  7. Aug 1, 2018

    SLATE RUN PHARMA — Marketing Organization

  8. Oct 11, 2018

    Sun Pharmaceuticals — Marketing Organization

  9. Oct 16, 2018

    Mylan — Marketing Organization

  10. Oct 16, 2018

    Rising Pharmaceuticals — Marketing Organization

  11. Nov 26, 2018

    Zydus Discovery DMCC — Marketing Organization

  12. Dec 27, 2018

    Teva — Marketing Organization

  13. Jun 28, 2019

    Lupin — Marketing Organization

2020s

  1. Apr 17, 2020

    Accord Research — Marketing Organization

  2. May 18, 2020

    ACME Laboratories — Marketing Organization

  3. May 18, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  4. Sep 18, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  5. Oct 7, 2020

    Hetero Labs Ltd — Marketing Organization

  6. Dec 2, 2021

    Amneal Pharmaceuticals — Marketing Organization

  7. Dec 2, 2021

    Jerome Stevens Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 8, 2004

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H](NCCCc1cccc(C(F)(F)F)c1)c1cccc2ccccc12
Mol. weight
357.42 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • amg 073
  • amg 073
  • amg 073
  • amg-073
  • amg-073
  • amg-073
  • amg-073 hcl
  • amg-073 hcl
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet
  • cinacalcet hcl
  • cinacalcet hcl
  • cinacalcet hcl
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • cnc
  • cnc
  • krn1493
  • krn1493
  • krn1493
  • mimpara
  • mimpara
  • mimpara
  • mimpara
  • n-((1r)-1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine
  • n-((1r)-1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine
  • (r)-alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-1-naphthalenemethane amine
  • (r)-alpha-methyl-n-[3-[3-(trifluoromethyl)phenyl]propyl]-1-naphthalenemethane amine
  • regpara
  • regpara
  • sensipar
  • sensipar
  • sensipar
  • sensipar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07122401Phase 3Sep 30, 2025Shaanxi Micot Technology Limited Company
NCT06288451Phase 2Mar 11, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington
NCT05926570Phase 4Aug 5, 2023Tanta University
NCT05663411Phase 2Jan 31, 2023Hengrui Therapeutics, Inc.
NCT03994172Phase 4Jul 1, 2019Department of Veteran Affairs, University of California, San Francisco
NCT03822507Phase 3Apr 9, 2019Kyowa Hakko Kirin
NCT03299244Phase 3May 15, 2018Amgen
NCT04637360N/AJan 1, 2018En Chu Kong Hospital, Min-Sheng General Hospital, National Taiwan University, Taipei Medical University, Tzu Chi University
NCT03123406Phase 4Apr 21, 2017Anhui Medical University, Capital Medical University, Foshan First People's Hospital, Fudan University, Jiao Tong University, Kyowa Hakko Kirin, Nanjing Medical University, Nanjing University, Peking University, Sichuan Huaxi Hopsital, Tianjin Medical University, Tsinghua University, Wuhan University, Xiamen University, Zhengzhou University
NCT03027557Phase 3Mar 1, 2017Aalborg University
NCT02525796Phase 2/Phase 3 (Phase 3)Jan 1, 2016Harvard University
NCT02549391Phase 2/Phase 3 (Phase 3)Sep 1, 2015Kyowa Hakko Kirin
NCT02440581N/AJul 1, 2015National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Kentucky, Wright State University
NCT02341417Phase 3Jun 10, 2015Amgen
NCT02338934Phase 4Jan 1, 2015Government of Malaysia, Penang Medical College
NCT02138838Phase 3Nov 7, 2014Amgen
NCT02216656Phase 2Jul 1, 2014Kyowa Hakko Kirin
NCT02227264N/AJun 1, 2014Karolinska Institute
NCT02133404Phase 2Mar 1, 2014Astellas
NCT02056730Phase 4Nov 1, 2013Chulalongkorn University
Showing 20 of 73 trials
Page 1 / 4

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit343341998
Kyowa Hakko KirinFor profit7542008
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2022015
Seoul National UniversityAcademic/Hospital2222008
University of KansasAcademic/Hospital2222005
Yeshiva UniversityAcademic/Hospital2212007
Aalborg UniversityAcademic/Hospital1112017
AbbottFor profit1112009
Anhui Medical UniversityAcademic/Hospital1012017
AstellasFor profit1112014
Capital Medical UniversityAcademic/Hospital1012017
Chinese University of Hong KongAcademic/Hospital1112010
Chulalongkorn UniversityAcademic/Hospital1112013
Department of Veteran AffairsGovernment1112019
En Chu Kong HospitalAcademic/Hospital1012018
Foshan First People's HospitalAcademic/Hospital1012017
Fudan UniversityAcademic/Hospital1012017
Government of MalaysiaGovernment1012015
Harvard UniversityAcademic/Hospital1112016
Hengrui Therapeutics, Inc.For profit1112023
61 organizations
Page 1 / 4

Marketing (26)

OrganizationOrg typeRelationshipDate
ACME LaboratoriesFor profitMKTGMay 18, 2020
Accord ResearchFor profitMKTGApr 17, 2020
Alkem Labs LtdFor profitMKTGApr 27, 2018
AmgenFor profitNDAMar 8, 2004
Amneal PharmaceuticalsFor profitMKTGDec 2, 2021
Aurobindo PharmaFor profitMKTGMar 8, 2018
Barr LaboratoriesFor profitMKTGMay 13, 2010
Chartwell PharmaceuticalsFor profitMKTGMay 18, 2020
CiplaFor profitMKTGMar 8, 2018
Dr. Reddy's LaboratoriesFor profitMKTGSep 18, 2020
Hetero Labs LtdFor profitMKTGOct 7, 2020
Jerome Stevens PharmaceuticalsFor profitMKTGDec 2, 2021
LupinFor profitMKTGJun 28, 2019
LupinFor profitSYNJun 28, 2019
MylanFor profitMKTGOct 16, 2018
MylanFor profitSYNOct 16, 2018
PiramalFor profitMKTGAug 1, 2018
PiramalFor profitSYNAug 1, 2018
Rising PharmaceuticalsFor profitMKTGOct 16, 2018
SLATE RUN PHARMAFor profitMKTGAug 1, 2018
Strides Pharma ScienceFor profitMKTGApr 30, 2018
Sun PharmaceuticalsFor profitMKTGOct 11, 2018
Sun PharmaceuticalsFor profitSYNOct 11, 2018
TevaFor profitSYNApr 25, 2017
TevaFor profitMKTGDec 27, 2018
Zydus Discovery DMCCFor profitMKTGNov 26, 2018