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Drug

Mecasermin

Approved · EMA
Late-stage development
Also known as INSULIN-LIKE GROWTH FACTOR I (HUMAN), Increlex, Mecasermin (E. Coli), Mechano growth factor+8 more

INSULIN-LIKE GROWTH FACTOR I (HUMAN), Increlex, Mecasermin (E. Coli), Mechano growth factor, RH-OLIGOPEPTIDE-2, VEXXON-IGF-1, Mecasermina, Mecasermin Recombinant, RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I, Recombinant human insulin-like growth factor 1, Recombinant human insulin-like growth factor I, Recombinant human somatomedin c.

RxNorm274403UNII7GR9I2683O
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Increlex Treatment of Children With Chronic Liver Disease and Short Stature

Clinical trial2026-04-14Withdrawn · ClinicalTrials.gov

Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

Clinical trial2013-06-01Terminated · ClinicalTrials.gov

IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

Clinical trial2012-11-01Completed · ClinicalTrials.gov

Approval: Increlex (EMA)

Regulatory2007-08-02EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mecasermin
Aliases & brands
INSULIN-LIKE GROWTH FACTOR I (HUMAN)IncrelexMecasermin (E. Coli)Mechano growth factorRH-OLIGOPEPTIDE-2VEXXON-IGF-1MecaserminaMecasermin RecombinantRECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-IRecombinant human insulin-like growth factor 1Recombinant human insulin-like growth factor IRecombinant human somatomedin c
RxNorm CUI
274403
UNII
7GR9I2683O
Regulatory jurisdictions
emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-08-02
Latest approval
2007-08-02
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2007-08-02Approval
Approval: Increlex (EMA)
Indication: For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD isShow full indication

For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score ? -3.0 and; basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and; growth hormone (GH) sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2020-01-27Safety communicationSafety
Drug Safety Update: Mecasermin (Increlex▼): risk of benign and malignant neoplasia
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
9
registered trials across all phases
LATEST COMPLETION 2022
5
Late-stage (III+)
6
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 9
Phase 11Phase 1 / 23Phase 2 / 31Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.