INCRELEX (mecasermin recombinant) · IPSEN
INCRELEX (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary insulin-like growth factor-1 (IGF-1) deficiency. It is also approved for patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. This therapy is specifically intended for patients with significant height and IGF-1 deficits who do not have secondary forms of deficiency, such as malnutrition or hypothyroidism.
How INCRELEX Works
Mecasermin functions as a recombinant form of IGF-1, a key hormone that mediates statural growth. It binds to and activates the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, to initiate intracellular signaling and stimulate growth. Beyond direct growth stimulation, the drug promotes metabolic actions including the uptake of glucose, fatty acids, and amino acids to support the development of growing tissues.
Details
- Status
- Prescription
- First Approved
- 2005-08-30
- Patent Cliff
- 2012
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
INCRELEX Approval History
What INCRELEX Treats
2 indicationsINCRELEX is approved for 2 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Failure
- IGF-1 Deficiency
INCRELEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to INCRELEX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
IPSEN's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02636270 results posted | 2015-6218 | Ph 1, Ph 2 | completed | IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INCRELEX FDA Label Details
Indications & Usage
FDA Label (PDF)INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX is not a substitute to GH for approved GH indications. Severe Primary IGF-1 Deficiency (Primary IGFD) INCRELEX is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: severe primary IGF-1 deficiency or growth hormone (GH) gene deletion who have developed neutralizing ...
Track INCRELEX with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.