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Fat LossStrong human clinical evidence FDA-approved label on file

Tesamorelin

GHRH analog (Egrifta) FDA-approved for HIV-associated lipodystrophy. Studied for visceral adiposity reduction outside that indication.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Phase 3 trials in HIV-associated lipodystrophy showed ~15% reduction in visceral adipose tissue at 26 weeks vs placebo. FDA approved 2010 for that specific indication.

What's still experimental

Use outside HIV lipodystrophy (e.g. general obesity), cognitive effects in mild cognitive impairment, and long-term safety beyond 1 year.

Anecdotal / community reports

Off-label use for body recomposition is common in research-peptide communities but human data outside HIV lipodystrophy is sparse.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
2 FDA-approved labels on file
  • EGRIFTA SV
    (TESAMORELIN) · Theratechnologies Inc.
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV 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 SV. EGRIFTA SV is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. ( 1 ) Limitations of use: Long-term cardiovascular safety of EGRIFTA…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. ( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5…

    Warnings

    5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV . Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA SV stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA SV therapy. Consider discontinuing in patients with persistent elevations. ( 5.2 ) Fluid retention: May occur with EGRIFTA SV and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA SV use. Evaluate glucose prior to and during therapy. ( 5.4 ) Hypersensitivity reactions: Have occurre…

  • EGRIFTA WR
    (TESAMORELIN) · Theratechnologies Inc.
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: 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. EGRIFTA WR is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. ( 1 ) Limitations of use: Long-term cardiovascular safety of EGRIFTA…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA WR (tesamorelin) for injection 11.6 mg per vial formulation. For recommendations for tesamorelin for injection 2 mg per vial formulation, see the EGRIFTA SV prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. EGRIFTA WR and EGRIFTA SV are not substitutable. ( 2.1 ). The dose of EGRIFTA WR is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA WR into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Bacteriostatic Water for Injection, USP, to reconstitute EGRI…

    Warnings

    5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA WR . Discontinue EGRIFTA WR if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA WR stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA WR therapy. Consider discontinuing in patients with persistent elevations. ( 5.2 ) Fluid retention: May occur with EGRIFTA WR and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WR use. Evaluate glucose prior to and during therapy. ( 5.4 ) Hypersensitivity reactions: Have occurre…

Doses studied in research

Source: FDA-approved label

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

FDA-approved labelEgrifta FDA label (DailyMed)
Indication studied: HIV-associated lipodystrophy
Typical
2mg(2,000 µg)
daily · subcutaneous

FDA-approved adult dose

Open calculator

Notes from the source: Single dose level approved. No titration. Indication is specific to HIV-associated lipodystrophy.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
Total actions
2
recalls + withdrawals
Ongoing
1
not yet completed
Class I (serious)
0
health hazard / death risk
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

    Reason: Lack of Assurance of Sterility

    Jul 30, 2025·GenoGenix LLC
  • Class IITerminated· Voluntary: Firm initiated
    FDA record

    Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

    Reason: Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date

    Sep 28, 2018·Tailor Made Compounding
FDA classifications: Class I = reasonable probability of serious adverse health consequences or death. Class II = temporary or medically reversible adverse consequences. Class III = unlikely to cause adverse health consequences.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL

Protein targets (UniProt)

  • Growth hormone-releasing hormone receptor
    Q02643gene: GHRHRHomo sapiens· 423 aaReviewed

    Receptor for GRF, coupled to G proteins which activate adenylyl cyclase. Stimulates somatotroph cell growth, growth hormone gene transcription and growth hormone secretion

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
120
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
3
24 total registered

Europe PMC — 361 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
372
all years
Last 5 years
176
recent activity
Open access
295
freely readable
OA share
79%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Semantic Scholar API is currently rate-limited.

Human-study summaries for “tesamorelin” are available on Semantic Scholar but the shared free-tier API quota is exhausted right now. Try refreshing in a few minutes, or check the PubMed and Europe PMC panels above for the same literature.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

NIH-funded research

U.S. National Institutes of Health
Funded projects
11
all years
Top award sum
$7.3M
aggregate USD
Years covered
11
research span
Largest active / recent grants

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
54
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • National Institutes of Health3 works
  • National Cancer Institute2 works
  • National Institute of Allergy and Infectious Diseases1 works
  • National Center for Advancing Translational Sciences (NCATS) Colorado CTSA1 works
  • National Cancer Institute, and the Nutrition Obesity Research Center at Harvard1 works
  • Massachusetts General Hospital1 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 5 of 5 preprints indexed by Europe PMC.

Known risks

Glucose intolerance/elevated HbA1c, fluid retention, injection-site reactions. Contraindicated in active malignancy and pituitary tumor. Pregnancy contraindicated.

Reported side effects

Injection-site reactions, joint pain, swelling, hyperglycemia, paresthesia.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
Reports filed
1,509
FAERS, all years
Serious reports
310
21% of reports
Top reporting countries
  • US1,482
  • IN1

Most-reported reactions

  • Product Dose Omission Issue
    278
  • Incorrect Dose Administered
    164
  • Injection Site Pain
    130
  • Product Preparation Issue
    121
  • Drug Ineffective
    119
  • Weight Increased
    96
  • Arthralgia
    88
  • Therapeutic Product Effect Incomplete
    86
  • Injection Site Bruising
    85
  • Wrong Technique In Product Usage Process
    78

Counts from FDA Adverse Event Reporting System (FAERS). Voluntary reports — they show what was reported, not whether the drug caused the event. Many reports lack confirmation. FAERS docs

What requires medical supervision

Prescription medication requiring monitoring of glucose, IGF-1, and any pituitary/oncologic history.

Questions for your clinician

  • Is my situation similar to the studied population (HIV lipodystrophy)?
  • What's the plan for glucose monitoring?
  • What's our exit criteria?

Editorially curated references

Discussions about Tesamorelin

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