Regulatory status

Tesamorelin FDA approval

The FDA approved tesamorelin on November 10, 2010, under the brand name EGRIFTA^[1,4]. It is approved for one indication. This page quotes the current prescribing information and lists every dated regulatory event from FDA and DailyMed records.

By Tesamorelin.app editorial teamSources reviewed November 11, 2026How we source

Approved indication

“EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.”

Quoted from the EGRIFTA WR prescribing information. The EGRIFTA SV label uses the same wording.^[2,3]

Limitations of use

The label lists three limitations of use, quoted here:

Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.
There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.

^[2]

Approved products

All approved tesamorelin products belong to one application, number 022505. It was filed as a new drug application. On March 23, 2020 it was deemed a biologics license application^[4]. Two products have current labels on DailyMed:

EGRIFTA SV: label revised 03/2024^[3,6].
EGRIFTA WR: approved March 25, 2025 as a new formulation with a multiple-dose presentation. Label revised 03/2025^[7,2].

Dosage and administration are covered in Section 2 of the prescribing information. This site does not reproduce them. Read the full prescribing information on DailyMed, and ask a licensed clinician about treatment.

What the approval does not cover

The approval covers only the indication above. The label states that the product is not indicated for weight-loss management^[2]. Studies in other populations, such as obesity without HIV, liver fat or cognition, are listed in the trial explorer. They are research findings, not approved uses.

Regulatory timeline

Every event below is dated from its primary record. Where sources disagree or leave out a date, the entry says so.

2009
1. May 29, 2009RegulatoryEGRIFTANDA 022505
  Original application submitted
  New drug application 022505 for EGRIFTA submitted to FDA (date per the 2010 approval letter).^[1]
  Primary record
2010
1. November 10, 2010ApprovalEGRIFTANDA 022505
  EGRIFTA approved
  Original approval as a new molecular entity (standard review) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.^[4]
  Primary record
2011
1. November 29, 2011SupplementEGRIFTANDA 022505
  Supplements S-001 and S-003 approved
  Chemistry/manufacturing (S-001) and labeling (S-003) supplements.^[4]
  Primary record
2015
1. June 8, 2015LabelingEGRIFTANDA 022505
  Labeling supplement S-007 approved
  Labeling supplement.^[4]
  Primary record
2018
1. November 2, 2018ApprovalEGRIFTA SVNDA 022505
  EGRIFTA SV formulation labeling approved
  Labeling for a second formulation, later marketed as EGRIFTA SV.^[5]
  Date note: Date taken from the S-011 letter; Drugs@FDA lists the matching S-010 supplement without an action date.
  Primary record
2019
1. January 18, 2019LabelingEGRIFTANDA 022505
  Supplement S-011 approved
  Changes-being-effected labeling update (logos and phone number).^[5]
  Primary record
2. July 5, 2019LabelingEGRIFTANDA 022505
  Labeling supplements S-012 and S-013 approved
  Labeling supplements.^[4]
  Primary record
2020
1. March 23, 2020RegulatoryEGRIFTA / EGRIFTA SVBLA 022505
  Application deemed a biologics license
  Under the transition provisions for biological products, NDA 022505 was deemed to be BLA 022505.^[4]
  Primary record
2024
1. January 23, 2024RegulatoryEGRIFTA WRBLA 022505
  FDA action on the EGRIFTA WR supplement
  FDA issued an action letter on the supplemental application for the EGRIFTA WR formulation (submitted 2023-09-22); the sponsor's 2024-11-25 amendment responded to it.^[7]
  Primary record
2. February 27, 2024LabelingEGRIFTA SVBLA 022505
  Supplement S-018 approved
  EGRIFTA SV labeling revised to conform to biological-product labeling requirements.^[6]
  Primary record
2025
1. March 25, 2025ApprovalEGRIFTA WRBLA 022505
  EGRIFTA WR approved
  Supplement S-020: a new formulation and multiple-dose presentation (EGRIFTA WR) with a new manufacturing site.^[7]
  Primary record
2. July 15, 2025LabelingEGRIFTA WRBLA 022505
  First EGRIFTA WR label on DailyMed
  Structured product label version 1 published.^[8]
  Primary record
2026
1. July 31, 2026LabelingEGRIFTA SVBLA 022505
  Current EGRIFTA SV label published
  DailyMed structured product label version 9.^[9]
  Primary record
2. August 3, 2026LabelingEGRIFTA WRBLA 022505
  Current EGRIFTA WR label published
  DailyMed structured product label version 2.^[8]
  Primary record

References

1.U.S. Food and Drug Administration. Approval letter, NDA 022505, EGRIFTA (tesamorelin for injection). November 10, 2010. FDA approval letter (PDF) · accessed 2026-11-11
2.EGRIFTA WR (tesamorelin) for injection, Prescribing Information. Revised 03/2025; DailyMed SPL version 2 (published 2026-08-03). DailyMed · accessed 2026-11-11
3.EGRIFTA SV (tesamorelin) for injection, Prescribing Information. Revised 03/2024; DailyMed SPL version 9 (published 2026-07-31). DailyMed · accessed 2026-11-11
4.U.S. Food and Drug Administration. Drugs@FDA: application 022505 (EGRIFTA), approval history and supplements. Drugs@FDA · accessed 2026-11-11
5.U.S. Food and Drug Administration. Supplement approval letter, NDA 022505/S-011. January 18, 2019. FDA letter (PDF) · accessed 2026-11-11
6.U.S. Food and Drug Administration. Supplement approval letter, BLA 022505/S-018. February 27, 2024. FDA letter (PDF) · accessed 2026-11-11
7.U.S. Food and Drug Administration. Supplement approval letter, BLA 022505/S-020 (EGRIFTA WR). March 25, 2025. FDA letter (PDF) · accessed 2026-11-11
8.DailyMed. EGRIFTA WR SPL version history. DailyMed history · accessed 2026-11-11
9.DailyMed. EGRIFTA SV SPL version history. DailyMed history · accessed 2026-11-11