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growth hormone

Trade name: Protropin

Biologicalapproved

Approved

Oct 17, 1985

Growth hormone (GH) or somatotropin, also known as human growth hormone in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in human development. GH also stimulates production of insulin-like growth factor 1 (IGF-1) and increases the concentration of glucose and free fatty acids. It is a type of mitogen which is specific only to the receptors on certain types of cells. GH is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland. — Wikipedia

Clinical trial activity

29 trials · 32 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
12
Phase 3
6
Phase 4
5

Earliest trial started Feb 29, 1992 (NCT01066052)

Timeline

1980s

  1. Oct 17, 1985

    Genentech — Earliest FDA Approval

  2. Oct 17, 1985

    Genentech — NDA Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewOct 17, 1985

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • growth hormone, human methionyl
  • methionyl human growth hormone
  • methionyl human growth hormone
  • n alpha-acetyl methionyl human growth hormone
  • protropin
  • protropin
  • protropin
  • protropin
  • protropin
  • somatonorm
  • somatotropin, n-l-methionyl-
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem
  • somatrem (genetical recombination)
  • somatrem (genetical recombination)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07264595Phase 1/Phase 2 (Phase 2)Dec 31, 2025GeneScience Pharmaceuticals Co., Ltd.
NCT07260500Phase 2Nov 11, 2025GeneScience Pharmaceuticals Co., Ltd.
NCT06907121Phase 2/Phase 3 (Phase 3)Jun 1, 2025Integrant Pty Ltd, University of Technology, Sydney
NCT06558422Phase 1Dec 1, 2024Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Berkeley
NCT06668805Phase 2Nov 30, 2024Biomarin
NCT06803589Early Phase 1 (Phase 1)Oct 22, 2024Mayo Clinic
NCT06382155Phase 2Sep 30, 2024Biomarin
NCT06379659Phase 1/Phase 2 (Phase 2)May 1, 2024Isfahan University
NCT06126354Phase 1Dec 1, 2023Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yeshiva University
NCT05724134Phase 1Aug 29, 2023Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yeshiva University
NCT05681299Phase 4May 1, 2023Columbia University
NCT05660356Early Phase 1 (Phase 1)Feb 28, 2023Pfizer, University of Calgary
NCT05585177N/ANov 1, 2022Nanjing Medical University, Nanjing University
NCT05447208Phase 3Aug 1, 2022Fudan University
NCT05838885Phase 2Feb 15, 2022Huazhong University of Science and Technology, Xiamen Amoytop Biotech Co., Ltd.
NCT05253287Phase 2/Phase 3 (Phase 3)Feb 1, 2022Postgraduate Institute of Medical Education and Research
NCT05187377Phase 2Jan 19, 2022Icahn School of Medicine at Mount Sinai, National Institute of Neurological Disorders and Stroke (NINDS)
NCT05089344N/AOct 9, 2021Ain Shams University
NCT05574894Phase 3Jan 1, 2021Fudan University
NCT04532554Phase 4Oct 26, 2020Assalam Clinics, ClinAmygate
Showing 20 of 29 trials
Page 1 / 2

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Columbia UniversityAcademic/Hospital4422023
Fudan UniversityAcademic/Hospital3322021
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3012023
BiomarinFor profit2212024
GeneScience Pharmaceuticals Co., Ltd.For profit2212025
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital2212018
Yeshiva UniversityAcademic/Hospital2012023
Ain Shams UniversityAcademic/Hospital1112021
Alexandria UniversityAcademic/Hospital1112020
Assalam ClinicsAcademic/Hospital1012020
Center for Neurological Studies (CNS)Academic/Hospital1112019
Central South UniversityAcademic/Hospital1112019
ClinAmygateFor profit1112020
Competence Centre on Health TechnologiesAcademic/Hospital1112010
GenentechFor profit1012004
Huazhong University of Science and TechnologyAcademic/Hospital1012022
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112022
Integrant Pty LtdAcademic/Hospital1112025
Isfahan UniversityAcademic/Hospital1112024
Mayo ClinicAcademic/Hospital1112024
32 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
GenentechFor profitNDAOct 17, 1985
GenentechFor profitIND—