Regulatory record

Regulatory recordSupporting passage inspected

Egrifta WR is indicated to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. It is not indicated for general weight-loss management, and long-term cardiovascular safety has not been established.[1]

Jurisdiction
United States
Product
EGRIFTA WR (tesamorelin)
Indication
Reduction of excess abdominal fat in adults with HIV-associated lipodystrophy
Record date
2026-09-08
  • The indication is specific to the approved product and HIV-associated lipodystrophy.
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.

Safety findings

Regulatory recordSupporting passage inspected

Egrifta WR is contraindicated in pregnancy, active malignancy and disruption of the hypothalamic-pituitary axis, among other labeled conditions. The label also addresses elevated IGF-1, glucose intolerance and fluid retention.[1]

  • A selected safety summary; consult the full label for all contraindications and monitoring information.
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

Egrifta WR and Egrifta SV are not substitutable. For WR, the label reports an approximately 11-minute elimination half-life after a single subcutaneous dose in healthy participants; a different formulation’s estimate should not be displayed as universal.[1]

  • This half-life is tied to the WR formulation and the labeled pharmacokinetic study.
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.

Restricted the regulatory, pharmacokinetic and selected safety findings to the inspected Egrifta WR label and formulation.

  • Other formulations and broad obesity or performance applications need 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.

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References

  1. EGRIFTA WR (tesamorelin) US prescribing information

    Theratechnologies Inc., US Food and Drug Administration. DailyMed SPL Set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75, Version 2, Effective Time 2026-07-29; labeled text revision March 2025. 2025-03. Product label.

    Inspected location: Highlights and full Sections 1, 2.1, 4, 5.1, 12.3; patient labeling revision stamp; DailyMed SPL packaging metadata

    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-egrifta-wr-2025: Sections 1, 2.1, 4, 5 and 12.3

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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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