Drugs / mecasermin
mecasermin
also known as
Insulin-like Growth Factor-I · Increlex · insulin-like growth factor-1 · rhIGF-1 · IGF-1 · IGF-I · rhIGF-I · Increlex (mecasermin), Ipsen · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | INCRELEX | — | 2024-03-15 | fda.gov ↗ |
| Approved | EU (EMA) | Increlex | — | 2007-08-02 | europa.eu ↗ |
| Approved | US (FDA) | INCRELEX | — | 2005-08-30 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01329744 | Jun 2011 → Jun 2013 | lipodystrophy | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02636270 | Dec 2015 → Oct 2022 | isolated short stature | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1/2 | NCT00490100 | Jun 2007 → Dec 2012 | T-B+ severe combined immunodeficiency due to gamma chain deficiency, growth hormone insensitivity syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT01525901 | Feb 2012 → Aug 2016 | Phelan-McDermid syndrome due to 22q13.3 deletion | Icahn School of Medicine at Mount Sinai | Completed | Missed primary |
| Phase 2 | NCT00572156 | Dec 2007 → Apr 2010 | growth delay due to insulin-like growth factor type 1 deficiency | Ipsen | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00004700 | Aug 1995 → Jan 1999 | hyperinsulinism | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00125190 | Jul 2005 → Jan 2009 | growth delay due to insulin-like growth factor type 1 deficiency | Ipsen | Completed | No outcome recorded |
| Phase 2/3 | NCT00571727 | May 1991 → Dec 2011 | growth hormone insensitivity syndrome | Ipsen | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT01301183 | Feb 2011 → Mar 2019 | anorexia nervosa | Massachusetts General Hospital | Completed | Missed primary |
| Phase 3 | NCT00330668 | Nov 2005 → Feb 2010 | growth delay due to insulin-like growth factor I resistance | Ipsen | Terminated | No outcome recorded |
| Phase 3 | NCT00125164 | Mar 2004 → Jul 2008 | growth delay due to insulin-like growth factor type 1 deficiency | Ipsen | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT01314508 | Jun → Oct 2011 | liver disorder | University of California, Los Angeles | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00004825 | May 1998 | hyperinsulinism | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| — | NCT00004419 | Apr 1998 → Sep 2000 | hyperglycemia | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| — | NCT00004699 | Aug 1995 → Jan 1999 | hyperinsulinism | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT03932162 Comparator | Sep 2019 → Dec 2025 overdue | sunburn | Wright State University | Recruiting | No outcome recorded |
| Phase 0 | NCT01834989 Comparator | Apr 2013 → Feb 2017 | disease of the tendon | Bispebjerg Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT01438086 Comparator | Oct 2011 → Feb 2016 | heart failure, myocardial infarction | University College Cork | Completed | No outcome recorded |
| Phase 3 | NCT01020955 Comparator | Oct 2009 → Nov 2011 | type 2 diabetes mellitus | Karolinska University Hospital | Completed | No outcome recorded |
| — | NCT01446783 Comparator | Sep 2011 → Nov 2012 | Ehlers-Danlos syndrome, classic type | Bispebjerg Hospital | Completed | No outcome recorded |
| — | NCT01588093 Comparator | Apr → Sep 2011 | type 1 diabetes mellitus | Peter Bang | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2017-09-12 | Takeda | Regulatory Shire Receives FDA Fast Track Designation for SHP607 for the Prevention of Chronic Lung Disease in Extremely Premature Infants takeda.com ↗
Cambridge, Mass. – September 12, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG ), the biotech leader in rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants. |
| 2009-01-21 | Insmed Incorporated | Regulatory Insmed and Premacure Announce European Orphan Designation for IPLEX(TM) in Retinopathy of Prematurity in Infants insmed.com ↗
today announced that the European Medicines Agency (EMEA) has granted Premacure orphan designation for Insmed's IPLEX(TM) product, also known as mecasermin rinfabate, for the prevention of retinopathy of prematurity (ROP) in neonates of less than 32 weeks of gestational age. |
| 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 ↗ |
| 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 ↗
In another clinical trial, once-daily treatment with IPLEX significantly improved height velocity in children with severe primary insulin growth factor-I (IGF-I) deficiencies. |
| 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. |
| 2005-12-12 | Insmed Incorporated | Regulatory FDA Approves Insmed's Orphan Drug, IPLEX, for the Treatment of Severe Primary IGF-1 Deficiency; The First Once-Daily Therapy for the Treatment of Severe Primary IFG-1 Deficiency insmed.com ↗
Insmed Incorporated (NASDAQ: INSM) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. |
| 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). |
| 2005-10-25 | Insmed Incorporated | Regulatory FDA to Review Insmed's Complete Response to Approvable Letter for iPlex insmed.com ↗
The FDA has established December 12, 2005 as its target to complete its 60-day review of the iPlex New Drug Application (NDA). |
| 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 ↗
Increases in height velocity were related to both the dose received and the IGF-I blood levels reached during treatment. |
| 2005-03-10 | Insmed Incorporated | Regulatory FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome insmed.com ↗
the Company has received the acceptance to file notification from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) |
| 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 ↗ |
| 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. |
| 2004-07-19 | 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. |
All press releases naming this drug 19 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mecasermin | “0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.” NCT01446783 ↗9“As a medication, IGF-1 is Increlex\[(Trademark)\] (mecasermin),” NCT00490100 ↗ “Mecasermin and Vivelle Dot patch” NCT01301183 ↗ |
| Known as | IGF-1 | “The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1) treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene...” NCT01525901 ↗2“Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1),...” NCT03932162 ↗ “Local administration of insulin-like growth factor-1 (IGF-1) in humans has been shown to quickly stimulate tendon collagen synthesis.” PMID 34138667 ↗ Jun 2021 |
| Known as | IGF-I | “Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism.” NCT00004825 ↗2“Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I).” NCT00004699 ↗ “recombinant human insulin-like growth factor I (IGF-I)” NCT00004700 ↗ |
| Known as | Increlex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01314508 ↗ |
| Known as | Increlex (mecasermin), Ipsen | “Increlex (mecasermin), Ipsen” NCT01446783 ↗ |
| Known as | insulin-like growth factor-1 | “Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1),...” NCT03932162 ↗3“Local administration of insulin-like growth factor-1 (IGF-1) in humans has been shown to quickly stimulate tendon collagen synthesis.” PMID 34138667 ↗ Jun 2021 |
| Known as | Insulin-like Growth Factor-I | “Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy” NCT01834989 ↗ |
| Known as | recombinant human IGF-I | “recombinant human IGF-I (rhIGF-I) therapy for short children with severe IGF-I deficiency” PMID 17192294 ↗ Dec 2006 |
| Known as | rhIGF-1 | “rhIGF-1 (mecasermin) for a period of 86 weeks” NCT00125190 ↗3“injections BID of rhIGF-1, mecasermin” NCT00571727 ↗ “rhIGF-1 (mecasermin, Tercica, Inc.)” NCT00125164 ↗ “Drug: rh IGF-1 (mecasermin)” NCT00330668 ↗ |
| Known as | rhIGF-I | “Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.” NCT00004419 ↗1“recombinant human IGF-I (rhIGF-I) therapy for short children with severe IGF-I deficiency” PMID 17192294 ↗ Dec 2006 |
| Action | Inhibit | “inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion” NCT00004825 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human insulin-like growth factor I (rhIGF-I)” NCT00004419 ↗ |
| Route | Subcutaneous | “first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I)” NCT00004419 ↗ |