somatropin
Trade name: protropin
Recombinant proteinapproved
Approved
Jul 30, 1976
Growth hormone therapy refers to the use of growth hormone (GH) as a prescription medication—it is one form of hormone therapy. Growth hormone is a peptide hormone secreted by the pituitary gland that stimulates growth and cell reproduction. In the past, growth hormone was extracted from human pituitary glands. Growth hormone is now produced by recombinant DNA technology and is prescribed for a variety of reasons. GH therapy has been a focus of social and ethical controversies for 50 years. — Wikipedia
Clinical trial activity
371 trials · 243 clinical orgs · 12 marketing orgs
Phase 1
46
Phase 2
196
Phase 3
136
Phase 4
67
Earliest trial started Sep 1, 1987 (NCT00001221)
Timeline
1970s
1980s
- Oct 16, 1986
Eli Lilly — NDA Secondary Org
- Jan 1, 1987
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1987
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
1990s
- May 8, 1995
Novo Nordisk — NDA Secondary Org
- May 25, 1995
Ferring — NDA Secondary Org
- Aug 24, 1995
Pharmacia — Marketing Organization
- Aug 24, 1995
Pharmacia & Upjohn — NDA Secondary Org
- Aug 23, 1996
Merck Serono — NDA Secondary Org
2000s
- Jan 1, 2000
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- May 30, 2006
Sandoz — NDA Secondary Org
- May 30, 2006
Novartis — NDA Secondary Org
- Apr 19, 2007
LG — NDA Secondary Org
- Jan 23, 2008
Emergent BioSolutions — NDA Secondary Org
Indications
Approved for
Studied for
- Achondroplasia · Phase 4
- Aging · Phase 2
- Airway Extubation · Phase 2
- Amyotrophic Lateral Sclerosis · Phase 2
- Anorexia Nervosa · Phase 2/Phase 3
- Anterior Cruciate Ligament Injuries · Phase 2
- Arthritis, Juvenile · Phase 3
- Ataxia Telangiectasia · Phase 4
- Atherosclerosis · Phase 3
- Body Image · Phase 4
- Body Weight Changes · Phase 1/Phase 2
- Bone Diseases, Metabolic · Phase 2
- Brain Concussion · Phase 3
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Burns · Phase 2/Phase 3
- Cardiovascular Diseases · Phase 4
- Chromosome Aberrations · Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 2
- Cognition · Phase 4
- Cognition Disorders · Phase 4
- Cognitive Dysfunction · Phase 3
- COVID-19 · Phase 3
- Crohn Disease · Phase 2/Phase 3
- Cystic Fibrosis · Phase 3
- Cystinosis · Phase 1/Phase 2
- Deficiency Diseases · Phase 1
- Delivery, Obstetric · Phase 3
- Developmental Disabilities · Phase 2
- Diabetes Mellitus · Phase 3
- Diabetes Mellitus, Type 1 · Phase 1
- Drugs, Investigational · Phase 2
- Dwarfism · Phase 4
- Endocrine System Diseases · Phase 3
- Exercise · Phase 4
- Failure to Thrive · Phase 3
- Familial Hypophosphatemic Rickets · Phase 1/Phase 2
- Fatigue · Phase 3
- Feeding and Eating Disorders · Phase 2
- Fertilization in Vitro · Phase 2
- Fetal Growth Retardation · Phase 3
- Fibromyalgia · Phase 3
- Fibrosis · Phase 2/Phase 3
- Fractures, Bone · Phase 2
- Frailty · Phase 2
- Genetic Diseases, Inborn · Phase 4
- Gestational Age · Phase 3
- Glucose Intolerance · Phase 4
- Gonadal Dysgenesis · Phase 2
- Growth · Phase 3
- Growth and Development · Phase 4
- Growth Disorders · Phase 3
- Growth Hormone · Phase 4
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 3
- Heart Failure · Phase 3
- Heart Failure, Systolic · Phase 3
- Hematopoietic Stem Cell Transplantation · Phase 1
- HIV · Phase 3
- HIV-Associated Lipodystrophy Syndrome · Phase 1/Phase 2
- HIV Wasting Syndrome · Phase 3
- Hormones · Phase 3
- Human Growth Hormone · Phase 3
- Hypogonadism · Phase 2
- Hypoparathyroidism · Phase 2/Phase 3
- Hypopituitarism · Phase 4
- Hypothyroidism · Phase 4
- Immunosenescence · Phase 2
- Infant, Premature, Diseases · Phase 2
- Infant, Small for Gestational Age · Phase 4
- Infant, Very Low Birth Weight · Phase 2
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Injury Severity Score · Phase 3
- Insulin · Phase 2
- Insulin Resistance · Phase 1/Phase 2
- Kidney Failure, Chronic · Phase 4
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 4
- Leukemia, Myeloid, Acute · Phase 2/Phase 3
- Lipodystrophy · Phase 4
- Metabolic Syndrome · Phase 4
- Mucopolysaccharidosis I · Phase 2/Phase 3
- Mucopolysaccharidosis II · Phase 2/Phase 3
- Mucopolysaccharidosis VI · Phase 2/Phase 3
- Multiple Myeloma · Phase 2/Phase 3
- Muscle Weakness · Phase 2
- Muscular Atrophy, Spinal · Phase 2
- Muscular Diseases · Phase 1/Phase 2
- Muscular Dystrophy, Facioscapulohumeral · Phase 1
- Myelodysplastic Syndromes · Phase 2/Phase 3
- Myocardial Ischemia · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Noonan Syndrome · Phase 3
- Obesity · Phase 4
- Obesity, Abdominal · Phase 3
- Osteoarthritis · Phase 1/Phase 2
- Osteoarthritis, Knee · Phase 2
- Osteogenesis Imperfecta · Phase 3
- Osteopetrosis · Phase 2/Phase 3
- Osteoporosis · Phase 3
- Ovarian Diseases · Phase 4
- Persian Gulf Syndrome · Phase 2
- Pituitary Diseases · Phase 3
- Pituitary Neoplasms · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2/Phase 3
- Pseudohypoparathyroidism · Phase 2/Phase 3
- Pseudopseudohypoparathyroidism · Phase 2/Phase 3
- Puberty, Delayed · Phase 2/Phase 3
- Renal Dialysis · Phase 3
- Rickets, Hypophosphatemic · Phase 1
- Sarcopenia · Phase 2
- Septo-Optic Dysplasia · Phase 4
- Spinal Cord Injuries · Phase 3
- Tendinopathy · Phase 2
- Uterine Diseases · Phase 3
- Ventilators, Mechanical · Phase 2
Mechanism of action
- Growth hormone receptorAGONIST
GHR agonist
It's a recombinant protein approved for the treatment of growth hormone deficiency
- SomatotropinSupplementation
GH1 supplementation
Approval history
- approvedJul 30, 1976
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaGrowth hormone therapy ↗
- NCATSNQX9KB6PCL ↗
- ChEMBLCHEMBL1201621 ↗
- WikipediaGrowth hormone ↗
Also known as
- accretropin
- altu-238
- asellacrin
- asellacrin 10
- asellacrin 2
- bio-tropin
- bplg-003
- cb-311
- cb-311
- crescormon
- da-3002
- da-3002
- genotropin
- genotropin
- genotropin goquick
- genotropin kabipen
- genotropin kabiquick
- genotropin kabivial
- genotropin miniquick
- genotropin [rdna origin]
- growth hormone
- growth hormone
- growth hormone (human)
- hgh
- hgh
- human growth factor
- human growth hormone
- human growth hormone
- human growth hormone
- humatrope
- humatrope
- humatropen
- maxomat
- nnc126-0083
- norditropin
- norditropin
- norditropin flexpro
- norditropin nordiflex
- norditropin penset
- norditropin simplexx
- nutropin
- nutropinaq
- nutropin aq
- nutropin aq pen
- nutropin depot
- omnitrope
- omnitrope
- omnitrope pen 10
- omnitrope pen 5
- omnitrope surepal 10
- omnitrope surepal 15
- omnitrope surepal 5
- peg-rhgh
- peg-rhgh
- peg-somatropin
- pegylated somatropin
- pegylated-somatropin
- polyethylene glycol-recombinant human growth hormone
- recombinant human growth hormone
- rhgh
- rhgh
- saizen
- saizen click.easy
- saizen easyject
- serostim
- serostim lq
- somatotropin
- somatotropin
- somatotropin
- somatotropin human
- somatotropin (human)
- somatotropin (human)
- somatotropin human growth hormone
- somatropin
- somatropin
- somatropin
- somatropin
- somatropin
- somatropin
- somatropin
- somatropin
- somatropin
- somatropine
- somatropin (rdna origin)
- somatropin [rdna origin]
- somatropin [rdna origin]
- somatropin [rdna origin]
- somatropin recombinant
- somatropin recombinant
- somatropin recombinant
- somatropin recombinant
- somatropin recombinant
- somatropin recombinant
- somatropin (recombinant dna origin)
- somatropin(recombinant dna origin)
- syntropin
- tev-tropin
- tev-tropin
- valtropin
- zomacton
- zorbtive
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07129759 | Phase 3 | Sep 30, 2026 | Lumos Pharma |
| NCT07226089 | Phase 3 | Feb 28, 2026 | Pfizer, Tel Aviv University |
| NCT07309562 | Phase 3 | Dec 30, 2025 | Huazhong University of Science and Technology, Xiamen Amoytop Biotech Co., Ltd. |
| NCT07221851 | Phase 3 | Nov 30, 2025 | Ascendis Pharma, Inc. |
| NCT06948214 | Phase 3 | Oct 31, 2025 | Lumos Pharma |
| NCT07036003 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2025 | University of Toronto |
| NCT07016802 | Phase 1 | Jun 23, 2025 | GeneScience Pharmaceuticals Co., Ltd., Peking University |
| NCT06927310 | Phase 3 | Apr 28, 2025 | Huazhong University of Science and Technology, Xiamen Amoytop Biotech Co., Ltd. |
| NCT06354023 | Phase 2 | Feb 8, 2025 | — |
| NCT06743997 | Phase 1 | Jan 15, 2025 | LG |
| NCT06385145 | Phase 1 | May 8, 2024 | GeneScience Pharmaceuticals Co., Ltd. |
| NCT06331026 | Phase 1 | Apr 9, 2024 | GeneScience Pharmaceuticals Co., Ltd. |
| NCT06103513 | Phase 3 | Dec 10, 2023 | Northwell Health |
| NCT06024967 | Phase 3 | Dec 1, 2023 | GeneScience Pharmaceuticals Co., Ltd., Morristown Memorial Hospital |
| NCT06007417 | Phase 3 | Dec 1, 2023 | GeneScience Pharmaceuticals Co., Ltd., University of Minnesota |
| NCT05796440 | Phase 2 | Aug 1, 2023 | Lumos Pharma |
| NCT05900661 | Phase 2/Phase 3 (Phase 3) | Jul 30, 2023 | Beni Suef University |
| NCT05746650 | N/A | Feb 24, 2023 | University of Copenhagen |
| NCT05690386 | Phase 2 | Feb 15, 2023 | Ascendis Pharma, Inc. |
| NCT06448195 | Phase 4 | Jan 1, 2023 | Fudan University |
Showing 20 of 371 trials
Page 1 / 19
Organizations
Research & Development (243)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 54 | 48 | 5 | 1987 |
| Pfizer | For profit | 37 | 20 | 5 | 1990 |
| GeneScience Pharmaceuticals Co., Ltd. | For profit | 25 | 24 | 4 | 2006 |
| Merck Serono | For profit | 22 | 8 | 4 | 1997 |
| Genentech | For profit | 19 | 2 | 4 | 1997 |
| Aarhus University | Academic/Hospital | 16 | 16 | 2 | 2005 |
| Huazhong University of Science and Technology | Academic/Hospital | 16 | 1 | 4 | 2006 |
| Eli Lilly | For profit | 14 | 11 | 3 | 1989 |
| Harvard University | Academic/Hospital | 13 | 12 | 3 | 2002 |
| Fudan University | Academic/Hospital | 11 | 1 | 3 | 2006 |
| Jiao Tong University | Academic/Hospital | 11 | 0 | 4 | 2009 |
| The University of Texas, Dallas | Academic/Hospital | 11 | 5 | 4 | 1992 |
| Ascendis Pharma, Inc. | For profit | 10 | 9 | 3 | 2009 |
| LG | For profit | 10 | 9 | 4 | 2003 |
| Merck KGaA | For profit | 10 | 10 | 3 | 1998 |
| Zhejiang University | Academic/Hospital | 10 | 0 | 3 | 2009 |
| Capital Medical University | Academic/Hospital | 9 | 0 | 3 | 2006 |
| National Institutes of Health (NIH) | Government | 9 | 4 | 3 | 1987 |
| Cairo University | Academic/Hospital | 7 | 2 | 2 | 2013 |
| Nanjing Medical University | Academic/Hospital | 7 | 0 | 3 | 2009 |
243 organizations
Page 1 / 13
Marketing (12)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eli Lilly | For profit | NDA2 | Oct 16, 1986 |
| Emergent BioSolutions | For profit | NDA2 | Jan 23, 2008 |
| Ferring | For profit | NDA2 | May 25, 1995 |
| Genentech | For profit | NDA2 | Apr 6, 1979 |
| LG | For profit | NDA2 | Apr 19, 2007 |
| Merck Serono | For profit | NDA2 | Aug 23, 1996 |
| Novartis | For profit | NDA2 | May 30, 2006 |
| Novo Nordisk | For profit | NDA2 | May 8, 1995 |
| Pharmacia | For profit | MKTG | Aug 24, 1995 |
| Pharmacia & Upjohn | For profit | NDA2 | Aug 24, 1995 |
| Sandoz | For profit | NDA2 | May 30, 2006 |
| Serono | For profit | NDA | Jul 30, 1976 |