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parathyroid hormone

Trade name: Natpara

Recombinant proteinapprovedOrphan Drug FDA

Approved

Jan 23, 2015

Parathyroid hormone (PTH) is an 84-amino acid peptide that regulates the function of osteoblasts and osteocytes and is secreted by the parathyroid gland in response to changes in the concentration of extracellular calcium. Parathyroid hormone is approved under the brand name NATPARA as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. It is also available for treatment of postmenopausal osteoporosis in many European countries. Parathyroid hormone is an activator of parathyroid hormone 2 receptor. In addition, was shown, that downregulation of Notch in osteoblasts and osteocytes may represent a mechanism contributing to the anabolic effects of parathyroid hormone in bone. — NCATS

Clinical trial activity

56 trials · 49 clinical orgs · 2 marketing orgs

Phase 1
16
Phase 2
33
Phase 3
17
Phase 4
7

Earliest trial started Sep 1, 1987 (NCT00005006)

Timeline

1980s

  1. Jan 1, 1987

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Aug 31, 2007

    Orphan Drug Designation

2010s

  1. Jan 23, 2015

    Earliest FDA Approval

  2. Jan 23, 2015

    NPS Pharma — Marketing Organization

  3. Jan 23, 2015

    Takeda — NDA Secondary Org

  4. Jan 24, 2015

    NPS Pharma — First NDA Organization

  5. Jan 24, 2015

    NPS Pharma — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 23, 2015

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • alx1-11
  • alx1-11
  • alx1-11
  • hpth
  • hpth
  • hpth(1-84)
  • hpth(1-84)
  • human parathyroid hormone
  • human recombinant parathyroid hormone
  • ly333334
  • natpara
  • natpara
  • npsp558
  • parathormone
  • parathormone
  • parathormone
  • parathormone (human recombinant)
  • parathyrin
  • parathyrin
  • parathyrin
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone
  • parathyroid hormone 1-34
  • parathyroid hormone 1-34
  • parathyroid hormone (1-84)
  • parathyroid hormone (1-84)
  • parathyroid hormone 1-84
  • parathyroid hormone 1-84
  • parathyroid hormone (1-84) human recombinant
  • parathyroid hormone, human
  • parathyroid hormone (rdna)
  • parathyroid hormone (rdna)
  • parathyroid horomone
  • paroidin
  • preotact
  • preotact
  • preotact
  • pth
  • pth
  • pth (1-84)
  • pth (1-84)
  • pth(1-84)
  • pth(1-84)
  • pth protein, human
  • rhpth
  • rhpth
  • rhpth (1-84)
  • rhpth(1-84)
  • rpth
  • rpth(1-84)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05965167Phase 1/Phase 2 (Phase 2)May 11, 2023Entera Bio Ltd.
NCT05164614Phase 1Mar 1, 2022RANI Therapeutics
NCT05137730Phase 1Nov 29, 2021Takeda
NCT05387070Phase 3Jul 28, 2021Peking University, Visen Pharmaceuticals
NCT04701203Phase 3Feb 16, 2021Ascendis Pharma, Inc.
NCT03878953Phase 3Aug 28, 2019Shire
NCT04009291Phase 2Jul 31, 2019Ascendis Pharma, Inc.
NCT03720886Phase 1/Phase 2 (Phase 2)Oct 1, 2018Chinese Academy of Medical Sciences, Shenzhen Salubris Pharmaceuticals Co., Ltd.
NCT03364738Phase 3Sep 28, 2018Shire
NCT03516773Phase 2Jun 17, 2018Entera Bio Ltd., Hebrew University
NCT03324880Phase 4Nov 27, 2017Shire
NCT03150108Phase 1May 16, 2017Shire
NCT02781844Phase 1Mar 11, 2017Shire
NCT02910466Phase 4Oct 1, 2016Shire
NCT02986607Early Phase 1 (Phase 1)Mar 1, 2016University of Bergen
NCT02478879Phase 1Jun 1, 2015Covance, Zosano Pharma Inc.
NCT01333267Phase 1Jan 1, 2015University of Pittsburgh
NCT02249780N/ASep 1, 2014University of Geneva
NCT02152228Phase 2Jul 1, 2014Entera Bio Ltd., Technion University
NCT01466829Phase 3Oct 1, 2012Aarhus University, Takeda
Showing 20 of 56 trials
Page 1 / 3

Organizations

Research & Development (49)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit161541995
University of PittsburghAcademic/Hospital6521999
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government5221999
National Institutes of Health (NIH)Government5231991
NPS PharmaFor profit5012001
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government4121987
TakedaFor profit4232006
Entera Bio Ltd.For profit3312014
Harvard UniversityAcademic/Hospital3221999
NycomedFor profit3312007
Aarhus UniversityAcademic/Hospital2222008
Ascendis Pharma, Inc.For profit2222019
Columbia UniversityAcademic/Hospital2221999
Helen Hayes HospitalAcademic/Hospital2111987
University of California, San FranciscoAcademic/Hospital2021999
Apollo Hospitals, Chennai, IndiaAcademic/Hospital1012005
Baylor UniversityAcademic/Hospital1012006
Bethesda Health Research CenterAcademic/Hospital1012000
Care Hospital, HyderabadAcademic/Hospital1012005
Chinese Academy of Medical SciencesAcademic/Hospital1012018
49 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
NPS PharmaFor profitMKTGJan 23, 2015
NPS PharmaFor profitNDAJan 24, 2015
TakedaFor profitNDA2Jan 23, 2015