Drugs / Somavaratan
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01359488 | Mar 2011 → Jun 2012 | pituitary deficiency | Versartis Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01718041 | Oct 2012 → Jul 2014 | pituitary deficiency | Versartis Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02719990 | Feb 2016 → Jan 2018 | pituitary deficiency | Versartis Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02526420 | Jul 2015 → Oct 2016 | pituitary deficiency | Versartis Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02413138 | Aug 2015 → Nov 2017 | pituitary deficiency | Versartis Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT02068521 | Mar 2014 → Nov 2017 | pituitary deficiency | Versartis Inc. | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03145831 | Mar → Nov 2017 | pituitary deficiency | Versartis Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02339090 | Aug 2015 → Aug 2017 | — | Versartis Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2008-09-23 | Insmed Incorporated | Results Insmed and Premacure Cite Study Results Demonstrating Potential Effectiveness of IPLEX(TM) in Preventing Blindness in Premature Infants insmed.com ↗ |
| 2008-01-28 | Insmed Incorporated | Results Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis insmed.com ↗
IPLEX(TM) appears to have been safe and well tolerated in the subject population to date and no individuals have dropped out of the study for reasons related to IPLEX(TM). |
| 2007-12-18 | Insmed Incorporated | Regulatory Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy insmed.com ↗
Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for IPLEX(TM) for the treatment of Myotonic Muscular Dystrophy (MMD). |
| 2004-07-19 | Insmed Incorporated | Results Insmed Announces Two Independent Presentations at the National Cancer Institutes 12th Annual Meeting of SPORE insmed.com ↗
In these experiments, treatment of cells with recombinant human IGFBP-3 and a RXR-specific ligand resulted in rapid nuclear localization of IGFBP-3. |
| 2003-11-17 | Insmed Incorporated | Results Insmed Presents Positive Data on Anti-Cancer Drug Candidate to AACR-NCI-EORTC insmed.com ↗
As a single agent, rhIGFBP-3 significantly inhibited the growth of breast and colorectal carcinoma cells 55% and 49%, respectively (p less than or equal to 0.01). |
| 2003-07-14 | Insmed Incorporated | Results Insmed Reports Positive Data to AACR with rhIGFBP-3 in Cancer insmed.com ↗
rhIGFBP-3 inhibited lung tumor growth by 70% as a single agent in mice. |
| 2003-06-02 | Insmed Incorporated | Results Insmed Presents Data To ASCO Highlighting Potential Benefit Of rhIGFBP-3 in Cancer; rhIGFBP-3 Shown to Enhance Chemotherapy in Models of Human Breast Cancer insmed.com ↗
In malignant cells, the results demonstrated that rhIGFBP-3 enhanced apoptosis induced by ceramide, antimycin A and the UV-mimetic 4 NQO between 50-200%. |
| 2003-05-29 | Insmed Incorporated | Results Insmed to Present Positive Cancer Data to ASCO insmed.com ↗
The results of the studies confirm that rhIGFBP-3 markedly enhanced cell death induced by a variety of apoptotic agents. |
| 2003-04-04 | Insmed Incorporated | Results Insmed Reports Positive Data with rhIGFBP-3 in Cancer; rhIGFBP-3 Improves Effect of Standard Cancer Therapies; rhIGFBP-3 Inhibits Tumor Growth up to 70% insmed.com ↗
rhIGFBP-3 inhibited lung tumor growth by 70% as a single agent in mice. |
| 2003-01-29 | Insmed Incorporated | Results Insmed Reports Positive Effects of SomatoKine -rhIGF-I/rhIGFBP-3- In Adolescent Subjects With Type 1 Diabetes insmed.com ↗
Insmed Incorporated (Nasdaq: INSM) announced today positive results from a dose-ranging trial of SomatoKine® (rhIGF-I/IGFBP-3) in adolescent patients with type 1 diabetes. |
| 2003-01-07 | Insmed Incorporated | Results Insmed Incorporated Announces Positive Preclinical Oncology Data With rhIGFBP-3 insmed.com ↗
Insmed Incorporated (Nasdaq:INSM) reported today that recombinant human IGFBP-3 (rhIGFBP-3) has demonstrated significant decrease in cell proliferation in vitro and a significant inhibition of tumor growth in vivo in several models of human cancers. |
| 2002-11-04 | Insmed Incorporated | Results Insmed Presents IGFBP-3 Anti-Cancer Data at the International Symposium on the Functional Role of IGFBP's insmed.com ↗
Laura J. Shiry, Ph.D., Director of Preclinical Development for Insmed Incorporated, presented to the conference a poster that detailed preclinical trials of Insmed's IGFBP-3. |
| 2002-07-18 | Insmed Incorporated | Results Insmed Presents Lead Drug Candidates At ENDO 2002, The 84th Annual Meeting of the Endocrine Society insmed.com ↗
IGF-1/IGF-BP3 (SomatoKine) Combination Improves Insulin Resistance by GH Dependent and GH Independent Mechanisms |
| 2002-07-17 | Insmed Incorporated | Regulatory Insmed Incorporated Receives Orphan Drug Designation for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome -Laron Syndrome- and Inititates Clinical Study insmed.com ↗
Insmed Incorporated (Nasdaq: INSM) today announced that the Office of Orphan Products Development of the Food and Drug Administration has approved the Company's application for orphan drug designation in the United States for SomatoKine®, for the treatment of growth hormone insensitivity syndrome (GHIS/LARON SYNDROME). |
All press releases naming this drug 14 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Somavaratan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02339090 ↗ |
| Known as | VRS-317 | “An Open-label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)” NCT02719990 ↗ |
| Modality | Protein / enzyme biologic | “long-acting rhGH analog, VRS-317” PMID 23585663 ↗ Apr 2013 |
| Route | Subcutaneous | “After Subcutaneous Administration of VRS-317” NCT01359488 ↗ |