Regulatory record

Regulatory recordSupporting passage inspected

Genotropin is FDA approved for specified pediatric growth disorders and adult growth-hormone deficiency. Its labeled indications do not include general anti-aging or enhancement in healthy adults.[1]

Jurisdiction
United States
Product
GENOTROPIN (somatropin)
Indication
Specified pediatric growth disorders and adult growth-hormone deficiency
Record date
2026-09-08
  • Approval applies to the defined product and diagnostic populations.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Independent fresh reinspection for the deep-evidence pass: reopened every cited source at its passages via NCBI E-utilities / DailyMed / accessdata.fda.gov / govinfo.gov / Wayback Machine mirror, checked Europe PMC correction/retraction metadata where applicable, and confirmed the claim's wording against the primary text. Disposition: supported within the stated scope. No qualified clinical review.

· Currency check for the regulatory-currency batch. The cited label is a fixed supplement document, so the application's Drugs@FDA submission history was read to confirm that no later supplement has replaced it. None has. The recorded date, the claim text and the sources are unchanged. Independent editorial review pending; no qualified clinical review.

Safety findings

Regulatory recordSupporting passage inspected

Genotropin labeling includes contraindications for active malignancy and specified acute critical illnesses, and warnings about impaired glucose tolerance, intracranial hypertension and fluid retention. These are product-label findings, not a personalized risk estimate.[1]

  • This selected summary does not replace the full indication-specific contraindication and warning sections.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Independent fresh reinspection for the deep-evidence pass: reopened every cited source at its passages via NCBI E-utilities / DailyMed / accessdata.fda.gov / govinfo.gov / Wayback Machine mirror, checked Europe PMC correction/retraction metadata where applicable, and confirmed the claim's wording against the primary text. Disposition: supported within the stated scope. No qualified clinical review.

Pharmacokinetics

Regulatory recordSupporting passage inspected

Genotropin’s label reports a mean terminal half-life of about 0.4 hours after intravenous somatropin in healthy adults and about 3 hours after subcutaneous administration in adults with growth-hormone deficiency. The longer apparent subcutaneous half-life reflects absorption.[1]

  • Route, formulation and population matter; these values cannot describe every growth-hormone product.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Independent fresh reinspection for the deep-evidence pass: reopened every cited source at its passages via NCBI E-utilities / DailyMed / accessdata.fda.gov / govinfo.gov / Wayback Machine mirror, checked Europe PMC correction/retraction metadata where applicable, and confirmed the claim's wording against the primary text. Disposition: supported within the stated scope. No qualified clinical review.

Interaction evidence

Regulatory recordSupporting passage inspected

Somatropin can reduce insulin sensitivity. GENOTROPIN labeling states this directly and warns that antihyperglycemic drug doses, including insulin, may need adjustment; HUMALOG's own drug-interaction table separately names somatropin among agents that may decrease HUMALOG's glucose-lowering effect. This does not establish an additive hypoglycemia effect of growth hormone.[1][2]

  • The insulin records group multiple preparations; the inspected insulin label is HUMALOG (lispro).
  • These passages do not test research secretagogues.
  • Somatropin appears only as one named example within a long generic drug-class list in HUMALOG's table; it is not a dedicated somatropin/lispro trial.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently re-retrieved both label PDFs on 2026-09-09; confirmed GENOTROPIN section 5.4 wording verbatim and located HUMALOG's own section 7 table naming somatropin (not previously cited from that specific table).

Mechanistic inferenceAbstract inspected

MK-677 reduced insulin sensitivity in an older-adult trial, and somatropin labeling warns of reduced insulin sensitivity. These individual-agent findings motivate a possible glycemic concern; the combination and its magnitude were not tested.[3][1]

  • MK-677 results cannot be assigned to every GHRH or ghrelin-related peptide.
  • Does not establish additive hypoglycemia with insulin.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Updated approved Genotropin indications, route/population-specific elimination estimates and important label contraindications.

  • Other somatropin formulations, long-acting analogues and unsupported healthy-user benefit claims require separate evidence.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. GENOTROPIN (somatropin) US prescribing information

    Pfizer Inc., US Food and Drug Administration. Application 020280 (listed in Drugs@FDA as BLA 020280), supplement s108; Reference ID 5621607; label revised July 2025. 2025-07. Product label.

    Inspected location: Highlights (indications, recent major changes 5.10); Section 1 (indications); Sections 4-5 (contraindications 4, warnings 5.1-5.7); Section 12.3 (pharmacokinetics, elimination paragraph, PDF p.18-19, Table); Reference ID 5621607

    This page cites a second record of the same publication. They are listed together so one study is not read as separate supporting evidence.

    Same publication, separate inspection record: Sections 5.4, 5.7 and 7.5 (PDF pages 8 and 14) Product label. Inspection record

    Study context and inspection record
  2. HUMALOG (insulin lispro) prescribing information

    2025-05. Product label.

    Inspected location: Sections 2.2, 5.2-5.6 and 7 (Drug Interactions table naming somatropin and albuterol) (PDF pages 3-7)

    Study context and inspection record
  3. Effects of an oral ghrelin mimetic on body composition and clinical outcomes in healthy older adults: a randomized trial

    2008-11-04. PMID:18981485 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-genotropin-2025: Sections 1, 4–5 and 12.3; route-specific elimination paragraph p. 18

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Related records in this class

Grouped under Peptides for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

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