Drugs / rhIGF-I/rhIGFBP-3
rhIGF-I/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 submission of the NDA for SomatoKine represents a great achievement for the Company” insmed.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00577577 | Dec 2007 → Dec 2008 | myotonic dystrophy type 1 | Insmed Incorporated | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00368173 | — | Laron syndrome | Insmed Incorporated | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01096784 Comparator | Jun 2010 → Mar 2016 | retinopathy of prematurity | Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2007-05-03 | Insmed Incorporated | Results Insmed Announces Promising Results From IPLEX Phase II Myotonic Muscular Dystrophy Clinical Study insmed.com ↗
Insmed Inc. (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored study of the company's drug, IPLEX(TM), in patients with myotonic muscular dystrophy (DM1). |
| 2007-04-30 | Insmed Incorporated | Results Insmed Releases Positive Results from IPLEX Phase II HIV-Associated Adipose Redistribution Syndrome Clinical Study insmed.com ↗
Preliminary results from the study, being conducted at the University of California, San Francisco, showed that three months of 0.5 mg/kg/day IPLEX treatment in seven patients increased IGF-I levels 3-fold and was associated with significant improvements in fasting glucose levels, the amount of insulin secreted during an oral glucose tolerance test, and overall insulin sensitivity. |
| 2006-12-13 | Insmed Incorporated | Results Insmed Announces Positive IPLEX(TM) Product Information At GRS-IGF Society Meeting in Kobe, Japan insmed.com ↗
The results confirm IPLEX's expanded stability and storage capabilities, allowing more flexibility in handling and administration for patients and caregivers. |
| 2006-07-05 | Insmed Incorporated | Regulatory European Medicines Agency Validates Insmed's Regulatory Application For Marketing IPLEX(TM) in Europe insmed.com ↗
Insmed today announced the European Medicines Agency (EMEA) has validated its application to market IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection), in the European Union (EU). |
| 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. |
| 2006-05-01 | Insmed Incorporated | Results IPLEX(TM) Demonstrates Significant, Dose-Dependent Increases in Growth Rate insmed.com ↗
The study showed that treatment resulted in statistically significant, dose-dependent increases in height velocity (growth rate) with a favorable safety profile. |
| 2006-04-26 | Insmed Incorporated | Results Insmed Announces Podium Presentation at the Pediatric Academic Societies' 2006 Annual Meeting insmed.com ↗
Treatment with IPLEX demonstrated statistically significant, dose dependent increases in Height Velocity with a favorable safety profile. |
| 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). |
| 2005-10-17 | Insmed Incorporated | Regulatory Insmed Submits Response to FDA Approvable Letter for iPlex insmed.com ↗
Insmed Incorporated (Nasdaq: INSM) announced today that it has submitted its response to the Approvable Letter received 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. |
| 2003-06-20 | Insmed Incorporated | Results Insmed Presents Positive Data on Lead Drug Candidate at Endocrine Society Annual Meeting; Study Shows Advantages of Company's rhIGF-I/rhIGFBP-3 In Treating Growth Disorder insmed.com ↗
RICHMOND, Va.--(BUSINESS WIRE)--June 20, 2003--Insmed Incorporated (Nasdaq: INSM) presented data today to ENDO 2003 from a study of rhIGF-I/rhIGFBP-3 in children with growth hormone insensitivity syndrome (GHIS), which demonstrated that a single daily dose of rhIGF-I/rhIGFBP-3 safely normalized serum IGF-I levels. |
| 2003-06-12 | Insmed Incorporated | Results Insmed to Report Positive Effects of rhIGF-I/rhIGFBP-3 In Adolescent Subjects with Type 1 Diabetes insmed.com ↗
It revealed that, following the administration of rhIGF-I/rhIGFBP-3, IGF-I blood levels were restored and increases in insulin sensitivity occurred in a dose-dependent manner. |
| 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 24 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhIGF-I/rhIGFBP-3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01096784 ↗ |
| Known as | Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 | “Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic...” NCT00577577 ↗ |
| Action | Restore | “physiologic replacement of rhIGF-1/rhIGFBP-3” PMID 27870826 ↗ Nov 2016 |
| Modality | Protein / enzyme biologic | “Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3” NCT00577577 ↗ |
| Route | Subcutaneous | “subcutaneous injections” NCT00577577 ↗ |