Drugs / Pegvisomant
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SOMAVERT | — | 2013-12-10 – 2023-07-27 | fda.gov ↗ |
| Approved | US (FDA) | SOMAVERT | — | 2003-03-25 | fda.gov ↗ |
| Approved | EU (EMA) | Somavert | — | 2002-11-12 | europa.eu ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01893866 | Aug → Oct 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00976508 | Nov 2009 → Sep 2011 | breast neoplasm, colorectal neoplasm, lung neoplasm, prostate neoplasm +1 | Pfizer | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05470504 | Jan 2023 → Jan 2028 expected | partial lipodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | No outcome recorded |
| Phase 2 | NCT02023918 | Jan 2014 → Aug 2015 | diabetes mellitus, metabolic syndrome X | University of California, San Francisco | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT03882034 | Oct 2019 → Sep 2025 | pituitary gland disorder | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 3 | NCT02952885 | Jul 2017 → May 2020 | acromegaly | Unity Health Toronto | Completed | No outcome recorded |
| Phase 3 | NCT00383708 | Oct 2006 → Oct 2008 | acromegaly | Ipsen | Completed | Mixed |
| Phase 3 | NCT00143416 | Apr 2004 → Jul 2007 | acromegaly | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00017927 | Jun 2001 → Jun 2005 | McCune-Albright syndrome, polyostotic fibrous dysplasia | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT02668172 | Aug 2015 → Mar 2017 | acromegaly | Erasmus Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01701973 | Jan 2013 → May 2017 | obesity disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00642720 | Oct 2006 → Jul 2007 | acromegaly | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01278342 | Sep 2006 → Nov 2009 | acromegaly | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00552851 | Jun 2006 → Dec 2010 | acromegaly, heart failure | University of Wuerzburg | Unknown | No outcome recorded |
| Phase 4 | NCT00151437 | Nov 2004 → Apr 2007 | acromegaly | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00068029 | Oct 2003 → May 2006 | acromegaly | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00068042 | Apr 2003 → May 2006 | acromegaly | Pfizer | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT04998500 | Aug 2021 → Dec 2023 | — | University of Aarhus | Unknown | No outcome recorded |
| — | NCT02500095 | Jul 2015 → Nov 2016 | — | University of Aarhus | Completed | No outcome recorded |
| — | NCT01261000 | Nov 2010 → Mar 2013 | acromegaly | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| — | NCT00652379 | Jun 2008 → Nov 2009 | acromegaly, glucose intolerance | University of Aarhus | Completed | No outcome recorded |
| — | NCT00476879 | Aug 2006 → Nov 2007 | fatty liver disease | University of Aarhus | Completed | No outcome recorded |
| — | NCT00512473 | Sep 2005 → Apr 2006 | — | University of Aarhus | Completed | No outcome recorded |
| — | NCT00468624 | Dec 2004 → Jul 2005 | pituitary deficiency | The Christie NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT01181973 Comparator | Oct 2010 → Jan 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00595140 Comparator | Jan → Mar 2008 | acromegaly | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT00376064 Background | Mar 2006 → Jan 2010 | acromegaly | Novartis Pharmaceuticals | Completed | No outcome recorded |
| — | NCT02782221 Comparator | May → Sep 2016 | metabolic disease | University of Aarhus | Completed | No outcome recorded |
| — | NCT01538966 Comparator | Mar 2012 → May 2022 | acromegaly | Cedars-Sinai Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01804413 Comparator | Mar 2011 → Nov 2013 | pituitary deficiency | Oregon Health and Science University | Unknown | No outcome recorded |
| — | NCT00969644 Comparator | Sep 2009 → Mar 2010 | growth hormone insensitivity syndrome with immune dysregulation | Herlev Hospital | Unknown | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegvisomant | “a GH-receptor antagonist (pegvisomant) followed by four AT biopsies” PMID 31668393 ↗ Aug 2019 |
| Known as | B-2036-PEG | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201515 ↗ |
| Known as | PEGV | “Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the investigators plan to study whether strict control of IGF-1, by adding or optimizing the use...” NCT02952885 ↗ |
| Known as | Pegwisomant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201515 ↗ |
| Known as | Somavent | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201515 ↗ |
| Known as | Somavert | “Concomitant Growth hormone receptor (GHR) blockade with Pegvisomant (Somavert) for inhibition of the fasting-induced GH secretion” NCT02500095 ↗ |
| Known as | Trovert | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201515 ↗ |
| Action | Inhibit | “a growth hormone receptor antagonist, pegvisomant” PMID 20003832 ↗ Dec 2009 |
| Modality | Protein / enzyme biologic | “Pegvisomant is a genetically engineered GH-receptor (GHR) antagonist” NCT03882034 ↗ |
| Route | Subcutaneous | “The drug and placebo will be injected under the skin, similar to insulin injections.” NCT00017927 ↗ |
| Target | GHR | “After 36 h of fasting with saline or pegvisomant (GHR blockade)” PMID 19820031 ↗ Oct 2009 |