Approved Therapeutic

Mecasermin

Increlex · Recombinant IGF-1

Mecasermin is an approved peptide-based therapeutic or diagnostic asset. Product-specific labels define its validated uses and risks.

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EvidenceTier 1
RegulatoryApproved
SafetyKnown but Manageable Risks
Clinical phaseApproved
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Overview

ClassRecombinant insulin-like growth factor 1
Sponsor / developerIpsen
Review statusReviewed
Record IDPEP-015
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Plain-language guide

What it was designed or studied for

Designed and approved for specific uses that include Severe primary IGF-1 deficiency.

How it works, simply

It replaces an important growth signal called IGF-1, helping cells respond to growth cues in people with a specific deficiency.

This simplified explanation is educational context, not a treatment recommendation or a substitute for the clinical evidence below.
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Clinical mechanism

Activates the IGF-1 receptor to support growth in a narrowly defined deficiency population.

Mechanism plausibility is not the same as demonstrated clinical benefit.
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Applications

  • Severe primary IGF-1 deficiency
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Human evidence

Multiple human studies and regulatory review support at least one product-specific indication.

Tier 1
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Preclinical evidence

Mechanistic and preclinical findings are tracked separately and are not treated as proof of human clinical benefit.

MAP

Muscle & recovery profile

Each signal is scored independently from 0–5. There is no composite “best” score.

Growth relevance4/5
Preservation relevance3/5
Recovery relevance1/5
Mitochondrial support1/5
Connective tissue1/5
Human-data depth4/5
Safety confidence3/5
Evidence–hype gap2/5

Evidence classes

  • Phase 3 / randomized human evidence

What has been studied

  • Growth outcomes have been evaluated in a narrowly defined deficiency population.

What is not established

  • Its approved evidence does not establish use for athletic performance or general hypertrophy.

Studied populations

  • Children with severe primary IGF-1 deficiency

Major limitations

  • Muscle-specific outcomes may be secondary, exploratory or absent from available studies.
  • Findings from one population, formulation or indication should not be generalized to another.

Evidence-source categories: primary regulatory record, clinical trial registry, peer reviewed literature. These editorial source categories require record-level primary links before publication-grade citation export.

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Regulatory status

Approved. Regulatory status is product- and jurisdiction-specific and does not automatically follow from an evidence score.

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Safety

Known but Manageable Risks

  • Adverse effects vary by product and indication
  • Contraindications and interactions require label review
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Interactions

Review the current product label and indication-specific literature for pharmacologic and absorption interactions.

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Treatment pattern

Treatment patterns are product-, indication- and clinician-specific; this educational profile does not provide dosing guidance.

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Manufacturing and quality

Approved-product identity, formulation and quality controls must not be extrapolated to compounded or RUO copies.

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Sources

  1. 01
    Primary regulatory record

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

  2. 02
    Clinical trial registry

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

  3. 03
    Peer-reviewed literature

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

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Gaps and unverified claims

  • Evidence must be interpreted by indication and product label.
  • Approval does not establish safety or efficacy for off-label or compounded copies.
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Last reviewed

August 5, 2026 · Reviewed