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Compound reference

PEG-MGF

Mechano Growth Factor

Peptides1 cited findingClinical review: not reviewed

Safety findings

Regulatory recordSupporting passage inspected

FDA’s review summary states that it did not identify human exposure data for PEG-MGF drug products and could not adequately characterize safety. The agency also raises potential immunogenicity and impurity concerns.[1]

  • The evidence gap does not establish either safety or clinical harm.
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.

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.

Retained FDA’s specific absence of identified administered-human data and potential immunogenicity/impurity concerns.

  • Direct human pharmacokinetics, repair outcomes and frequency of harm remain unresolved.
  • 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.

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References

  1. FDA: Certain bulk drug substances for compounding that may present significant safety risks

    US Food and Drug Administration. FDA web page. The footer states "Content current as of: 04/22/2026" (22 April 2026), independently verified on 2026-09-09 by two separate fetch methods. The ibutamoren mesylate row's own dated actions remain the applicable dates for that row's content. 2026-04-22. Regulatory document.

    Inspected location: Ibutamoren mesylate row of the 503A/503B category-2 bulk-substances table: congestive-heart-failure safety-risk description and the row's own dated entries (503A added September 29, 2023; 503B added December 29, 2022). Also inspected for this batch: the category-2 table row for kisspeptin-10, and the withdrawn-nomination rows for BPC-157, cathelicidin LL-37, emideltide (DSIP), epitalon, GHK-Cu, melanotan II, MOTs-C, selank acetate (TP-7), semax (heptapeptide) and thymosin alpha-1; and the earlier named GHRP-6, PEG-MGF, GHK-Cu and GHRP-2 rows

    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-fda-bulk-safety: Named rows: GHRP-6, PEG-MGF, GHK-Cu, GHRP-2 and ibutamoren; current and withdrawn-nomination tables

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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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