Drugs / rhIGF-1/rhIGFBP-3
rhIGF-1/rhIGFBP-3
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | SomatoKine | growth hormone insensitivity syndrome with immune dysregulation | 2005-01-03 | “the FDA had accepted Insmed's NDA submission for SomatoKine for the treatment of children with Growth Hormone Insensitivity Syndrome (GHIS)” insmed.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of SomatoKine(R)” insmed.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT00233519 | Nov 2005 → May 2008 | myotonic dystrophy type 1 | University of Rochester | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2006-06-27 | Insmed Incorporated | Results Insmed Presents Positive IPLEX(TM) Data At ENDO 2006 insmed.com ↗
Insmed, Inc. (NASDAQ: INSM) today announced new study results that show that IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) is effective in increasing growth and improving glycemic control in patients with severe insulin-resistance syndromes, specifically Leprechaunism and Type A syndrome. |
| 2005-11-29 | Insmed Incorporated | Results Insmed Provides Update on iPlex Pivotal Trial Data in Severe Primary IGF-1 Deficiency insmed.com ↗
The data demonstrated that as a once-daily IGF-1 therapy, iPlex safely and significantly increased height velocity, the primary endpoint of the study, in children with short stature due to Severe Primary IGF-1 deficiency. |
| 2005-11-25 | Insmed Incorporated | Regulatory Insmed Receives Approvable Letter for iPlex(TM); Conference Call Tomorrow at 8:00am EST insmed.com ↗
Insmed Incorporated (NASDAQ-NMS: INSM) (NASDAQ: INSM) announced today the receipt of an Approvable Letter from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD). |
| 2005-05-31 | Insmed Incorporated | Results Insmed Reports Detailed Positive Results from Its Pivotal Clinical Trial of SomatoKine in Patients with Growth Hormone Insensitivity Syndrome insmed.com ↗
Of the 29 patients enrolled in the study, 25 patients had sufficient data for 6 months to qualify as evaluable for efficacy. |
| 2005-01-03 | Insmed Incorporated | Regulatory Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome insmed.com ↗
Insmed Incorporated (Nasdaq: INSM) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of SomatoKine(R) (mecasermin rinfabate) for the treatment of growth hormone insensitivity syndrome (GHIS). |
| 2004-10-25 | Insmed Incorporated | Regulatory Insmed Receives European Orphan Drug Designation for SomatoKine for the Treatment of Extreme Insulin Resistance; Company to Initiate Clinial Trial in Type A Insulin Resistance insmed.com ↗
Insmed Incorporated (Nasdaq: INSM) today announced that the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) has approved the Company's application for orphan drug designation in Europe for SomatoKine(R), for the treatment of extreme insulin resistance. |
| 2004-09-13 | Insmed Incorporated | Results Insmed Reports Results from Nine Months of SomatoKine Therapy for a Patient with Extreme Insulin Resistance at the 43rd Meeting of the European Society of Pediatric Endocrinology insmed.com ↗
The nine-month analysis demonstrated substantial improvements in growth, metabolic control, and neurological development. |
| 2004-07-20 | Insmed Incorporated | Results Insmed Reports Update on Pivotal Clinical Trial with SomatoKine: Statistically Significant Increase in Growth Rate Observed at Six Months insmed.com ↗
The six-month data analysis showed a statistically significant increase (p |
| 2004-07-19 | Insmed Incorporated | Regulatory Insmed Receives Authorization for Reimbursement for SomatoKine Named Patient Program from France and Italy; Newly Appointed Chief Business Officer Expands the Named Patient Program insmed.com ↗
Insmed Incorporated (Nasdaq:INSM) today announced the French authorities have authorized the use of and reimbursement for SomatoKine(R) (rhIGF-I/rhIGFBP-3) in the treatment of an infant with a rare and life-threatening type of extreme insulin resistance. |
| 2003-12-15 | Insmed Incorporated | Regulatory Insmed Receives FDA Orphan Drug Designation For rhIGF-I/rhIGFBP-3, SomatoKine, for Extreme Insulin Resistance 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 extreme insulin resistance. |
| 2003-12-02 | Insmed Incorporated | Results rhIGF-I/rhIGFBP-3, SomatoKine, Found to Delay the Onset of Type I Diabetes insmed.com ↗
Insmed's (NASDAQ: INSM) rhIGF-I/rhIGFBP-3 (SomatoKine®), has been found by an independent research team to protect from the onset of type 1 diabetes in non-obese diabetic 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. |
All press releases naming this drug 16 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhIGF-1/rhIGFBP-3 | “Participants received escalating dosages of subcutaneous rhIGF-1/rhIGFBP-3 for 24 weeks followed by a 16-week washout period.” PMID 20837825 ↗ Sep 2010 |
| Known as | IPLEX | “Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic...” NCT00233519 ↗ |
| Known as | rhIGF-I/rhIGFBP-3 | “Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic...” NCT00233519 ↗ |
| Known as | SomatoKine | “Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic...” NCT00233519 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human insulin-like growth factor 1 (rhIGF-1) complexed with IGF binding protein 3 (rhIGF-1/rhIGFBP-3)” PMID 20837825 ↗ Sep 2010 |
| Route | Subcutaneous | “The aim of this study is to investigate the safety and feasibility of daily subcutaneous injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED)” NCT00233519 ↗ |