pegvisomant
Trade name: somavert
Approved
Mar 25, 2003
Pegvisomant, sold under the brand name Somavert, is a growth hormone receptor antagonist used in the treatment of acromegaly. It is primarily used if the pituitary gland tumor causing the acromegaly cannot be controlled with surgery or radiation, and the use of somatostatin analogues is unsuccessful, but is also effective as a monotherapy. It is delivered as a powder that is mixed with water and injected under the skin. — Wikipedia
Clinical trial activity
31 trials · 18 clinical orgs · 2 marketing orgs
Earliest trial started Jun 1, 2001 (NCT00017927)
Timeline
1990s
- Jun 24, 1997
Orphan Drug Designation
2000s
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Mar 25, 2003
Pharmacia & Upjohn — Earliest FDA Approval
- Mar 25, 2003
Pharmacia — Marketing Organization
- Mar 25, 2003
Pharmacia & Upjohn — NDA Organization
- Mar 25, 2003
Pharmacia & Upjohn — NDA Secondary Org
- Mar 25, 2003
Pharmacia — NDA Secondary Org
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2014
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Biological Availability · Phase 1
- Breast Neoplasms · Phase 1
- Colorectal Neoplasms · Phase 1
- Diabetes Mellitus · Phase 2
- Fibrous Dysplasia, Polyostotic · Phase 3
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 4
- Hypertrophy, Left Ventricular · Phase 4
- Insulin Resistance · Phase 2
- Lipodystrophy · Phase 2
- Lung Neoplasms · Phase 1
- Metabolic Syndrome · Phase 2
- Mutation · Phase 2
- Obesity · Phase 4
- Pituitary Diseases · Phase 3
- Prostatic Neoplasms · Phase 1
- Quality of Life · Phase 4
- Sarcoma · Phase 1
Mechanism of action
- Growth hormone receptorAGONIST
GHR agonist
- Growth hormone receptorANTAGONIST
GHR antagonist
It's a recombinant protein which selectively binds to growth hormone receptor
Approval history
- approvedFast trackMar 25, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaPegvisomant ↗
- NCATSN824AOU5XV ↗
- ChEMBLCHEMBL1201515 ↗
Also known as
- b-2036 peg
- b-2036 peg
- b-2036 peg
- b-2036 peg
- b-2036 peg
- b2036-peg
- b2036-peg
- b2036-peg
- pegisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant
- pegvisomant (genetical recombination)
- somavert
- somavert
- somavert
- somavert
- somavert
- trovert
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05470504 | Phase 2 | Dec 29, 2022 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT04998500 | N/A | Aug 1, 2021 | Aarhus University, University of Copenhagen |
| NCT03882034 | Phase 3 | Jul 5, 2019 | National Institutes of Health (NIH) |
| NCT02952885 | Phase 3 | Jan 1, 2017 | University of Toronto |
| NCT02782221 | N/A | May 1, 2016 | Aarhus University |
| NCT02668172 | Phase 4 | Aug 1, 2015 | Erasmus University Rotterdam, Novartis |
| NCT02500095 | N/A | Jul 1, 2015 | Aarhus University |
| NCT02023918 | Phase 2 | Jan 1, 2014 | University of California, San Francisco |
| NCT01893866 | Phase 1 | Aug 1, 2013 | Pfizer |
| NCT01701973 | Phase 4 | Jan 1, 2013 | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Vanderbilt University |
| NCT01538966 | N/A | Jan 1, 2012 | Cedars-Sinai Medical Center |
| NCT01804413 | N/A | Mar 1, 2011 | Aarhus University, Oregon Health and Science University |
| NCT01261000 | N/A | Nov 1, 2010 | Cedars-Sinai Medical Center |
| NCT01181973 | Phase 1 | Oct 1, 2010 | Pfizer |
| NCT00976508 | Phase 1 | Nov 1, 2009 | Pfizer |
| NCT00969644 | N/A | Sep 1, 2009 | University of Copenhagen |
| NCT00652379 | N/A | Jun 1, 2008 | Aarhus University |
| NCT00595140 | Phase 4 | Jan 1, 2008 | Ludwig Maximilians University |
| NCT00383708 | Phase 3 | Oct 1, 2006 | Ipsen |
| NCT00642720 | Phase 4 | Oct 1, 2006 | Erasmus University Rotterdam |
Organizations
Research & Development (18)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 9 | 7 | 4 | 2003 |
| Aarhus University | Academic/Hospital | 7 | 6 | 1 | 2005 |
| Novartis | For profit | 3 | 2 | 1 | 2006 |
| Cedars-Sinai Medical Center | Academic/Hospital | 2 | 2 | 1 | 2010 |
| Erasmus University Rotterdam | Academic/Hospital | 2 | 2 | 1 | 2006 |
| National Institutes of Health (NIH) | Government | 2 | 1 | 2 | 2013 |
| University of Copenhagen | Academic/Hospital | 2 | 1 | 1 | 2009 |
| Ipsen | For profit | 1 | 1 | 1 | 2006 |
| Julius-Maximilians University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Ludwig Maximilians University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2013 |
| National Institute of Dental and Craniofacial Research (NIDCR) | Government | 1 | 1 | 1 | 2001 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 1 | 1 | 1 | 2022 |
| Oregon Health and Science University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| The Christie NHS Foundation Trust | Academic/Hospital | 1 | 1 | 1 | 2004 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2014 |
| University of Toronto | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Vanderbilt University | Academic/Hospital | 1 | 1 | 1 | 2013 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pharmacia | For profit | MKTG | Mar 25, 2003 |
| Pharmacia | For profit | NDA2 | Mar 25, 2003 |
| Pharmacia & Upjohn | For profit | NDA | Mar 25, 2003 |
| Pharmacia & Upjohn | For profit | NDA2 | Mar 25, 2003 |