mecasermin
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 22 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 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 1/22 trials | ||||||
| Phase 1/2 | NCT01438086 Comparator | Oct 2011 → Feb 2016 | heart failure, myocardial infarction | University College Cork | Completed | No outcome recorded |
| Phase 1/2 | NCT00684957 Comparator | Jan 2008 → Oct 2012 | pituitary deficiency | Columbia University | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01020955 Comparator | Oct 2009 → Nov 2011 | type 2 diabetes mellitus | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00035815 Comparator | Jun 2003 → Aug 2007 | amyotrophic lateral sclerosis | Mayo Clinic | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01406444 Comparator | Oct 2011 → May 2019 | anorexia nervosa, osteoporosis | Massachusetts General 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 |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 34 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 | CEP-151 | “The drug rhIGF-1 (CEP-151) has been shown to play a key role preclinically in oligodendrocyte differentiation and survival” NCT00001669 ↗ |
| 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 ↗8“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 ↗ “A total of 330 patients from 20 medical centers were randomized to receive 0.05 mg/kg body weight of human recombinant IGF-1 given subcutaneously twice daily or placebo for 2 years.” PMID 19029516 ↗ Nov 2008 “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 “using a medication known as IGF-1 (mecasermin or INCRELEX)” NCT01253317 ↗ |
| Known as | IGF-I | “The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients.” NCT00035815 ↗3“Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism.” NCT00004825 ↗ “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 NCT02636270 ↗ |
| Known as | Increlex (mecasermin [rDNA origin] injection) | “Increlex (mecasermin [rDNA origin] injection)” NCT01207908 ↗ |
| Known as | Increlex (mecasermin), Ipsen | “Increlex (mecasermin), Ipsen” NCT01446783 ↗ |
| Known as | Insulin-like growth factor type I | “BACKGROUND: Previous human clinical trials of insulin-like growth factor type I (IGF-1) in amyotrophic lateral sclerosis (ALS) have been inconsistent.” PMID 19029516 ↗ Nov 2008 |
| 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 ↗4“The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients.” NCT00035815 ↗ “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 | MyotrophinTM | “The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression of weakness in amyotrophic lateral sclerosis (ALS).” NCT00035815 ↗ |
| Known as | Recombinant Human IGF-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00684957 ↗ |
| 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 ↗7“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 | “Subcutaneously Administered Insulin-Like Growth Factor-1” NCT00001669 ↗ |