Is Tesamorelin FDA-Approved? What Application 022505 Covers | Artemis Labs

Posted on by Kate Cai
Card summarizing the FDA Purple Book record for the approved tesamorelin product: application 022505, licence 2091, Theratechnologies, first approval November 2010
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Is tesamorelin FDA-approved? What application 022505 actually covers

Published August 28, 2026 · Artemis Labs

Tesamorelin FDA approval — Tesamorelin is the International Nonproprietary Name of a compound for which an FDA-approved prescription drug product exists. That product is marketed by Theratechnologies Inc. under the brand names EGRIFTA, EGRIFTA SV and EGRIFTA WR, under FDA application 022505, first approved in November 2010. It is listed in the FDA Purple Book as a 351(a) biologic, license number 2091. Its approved indication, in the label’s own words, is the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The approval attaches to that manufactured product, its named company, drug substance and presentation. It does not attach to a sequence, and it does not attach to research-grade material made by anyone else.

Key findings

  • An approval exists, and it is specific. FDA Purple Book record for application 022505: Proper Name tesamorelin, BLA Type 351(a), Licensure Licensed No. 2091, Company Theratechnologies Inc., dates 10-Nov-10, 29-Nov-11 and 25-Mar-25.
  • It is in the Purple Book, not the Orange Book. PubChem’s record for tesamorelin carries an FDA Purple Book section and no FDA Orange Book section. An Orange Book search returns nothing and wrongly suggests the compound is unapproved.
  • The indication is one lane wide. Both current labels (EGRIFTA SV and EGRIFTA WR) state the indication verbatim as the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy, with a Limitations of Use statement that long-term cardiovascular safety … has not been established.
  • Approval attaches to a product, not a molecule. The record is organized around an application number, a license number, a company, a dosage form, a product presentation and a named drug substance, tesamorelin acetate (UNII LGW5H38VE3). None of those fields describe a sequence.

What does the FDA Purple Book record say, field by field?

The FDA Purple Book is the agency’s database of licensed biological products. PubChem transcribes the Purple Book entry for this licensed product from purplebooksearch.fda.gov. The register’s fields, quoted in full, are: Application Number: 022505 · Proper Name: tesamorelin · Status: Rx; Disc · Product Presentation: Multi-Dose Vial; Single-Dose Vial · BLA Type: 351(a) · Licensure: Licensed No. 2091 · Date: 29-Nov-11; 25-Mar-25; 10-Nov-10 · Company: Theratechnologies Inc. The same Purple Book record lists the approved product’s dosage form as injection and its route of administration as subcutaneous; those two fields are the register’s description of the licensed product and are reproduced as regulatory provenance and nothing more.

Three of those fields need reading carefully. 10-Nov-10 is the earliest of the three dates and is independently corroborated by a 2012 pharmacy review stating the product was approved by the Food and Drug Administration in November 2010 (PMID 22298602); which product actions the other two dates correspond to is not labeled in the field and is unverified. Rx; Disc means the record carries both a prescription status and a discontinued status against its presentations; which presentation is discontinued is not stated, and the FDA National Drug Code directory shows current listings for EGRIFTA SV (NDC 62064-241, from 2019-11-04) and EGRIFTA WR (NDC 62064-381, from 2025-07-15), so no claim that tesamorelin “is discontinued” or “is not discontinued” can be made from this field alone. And BLA Type 351(a), together with the license number, means the product is regulated today as a licensed biologic, even though the application number is in the older NDA format. The history of how that came to be is not stated by the primary source and is not stated here.

Why does an Orange Book search miss it?

The Orange Book lists approved drug products with therapeutic-equivalence evaluations; the Purple Book lists licensed biological products. Tesamorelin’s PubChem record, which enumerates every FDA annotation attached to the compound, contains a FDA Purple Book section and no FDA Orange Book section at all. Anyone who checks approval status by searching the Orange Book, which is the habit for small-molecule drugs, finds nothing and concludes the compound is unapproved. It is not. It is in the other book. This is the single most common way the tesamorelin regulatory status is stated wrongly in both directions.

What is the approved indication, exactly?

The DailyMed label records for both current presentations carry the same indication sentence. For EGRIFTA WR: 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. The EGRIFTA SV label is identical with the product name changed. Lipodystrophy here is the abnormal fat redistribution associated with antiretroviral therapy for HIV.

That is the whole indication. There is no approved indication for cognition, for liver fat, for obesity in people without HIV, for muscle, for aging or for anything else, and a claim that any such indication exists is false. Our earlier product copy at one point carried a second, invented indication in the growth-hormone-deficiency area; it does not exist and was removed in August 2026. The trial evidence outside the approved indication is the subject of a separate page, and it is thin.

The WHO ATC code is H01AC06, under Somatropin and somatropin agonists. Two 2024 and 2011 papers describe the product in narrow published forms as the only FDA-approved therapy to treat abdominal fat accumulation in people with HIV (PMID 38905488) and as the first and, so far, only treatment indicated for the reduction of excess abdominal fat in patients with HIV-associated lipodystrophy (PMID 21668043). Those are the attributed forms; the broader class-wide claim sometimes made about GHRH analogs as a group is not stated by the primary record and is not stated here.

What are the three brand names?

Three brand generations exist under the one application. EGRIFTA is the original brand, named in PubChem’s synonyms, the MeSH entry terms, the 2016 Health Canada CADTH review titles and the 2011 Adis drug profiles; it has no current NDC listing, which is consistent with the Disc in the Purple Book status. EGRIFTA SV has NDC 62064-241, listed from November 2019. EGRIFTA WR has NDC 62064-381, listed from July 2025. What “SV” and “WR” denote, and how the formulations differ, is not stated by any source we checked and is not stated here; neither name resolves in PubChem at all. The drug substance in the labels is TESAMORELIN ACETATE (UNII LGW5H38VE3); the active moiety is TESAMORELIN (UNII MQG94M5EEO).

Why does none of this attach to a research vial?

Because approval is granted to a product, not to a molecule. The FDA record is organized around an application number, a license number, a named company, a named dosage form, a named product presentation and a named drug substance with its own UNII. Every one of those fields describes something Theratechnologies makes and FDA reviewed. None of them describes a sequence. Material with the same sequence, made by anyone else under any process, is not covered by application 022505, is not EGRIFTA, and is not “the same as” EGRIFTA in any regulatory sense. The published trial results are that product’s results, reported on our trial-record page as such.

Artemis Labs sells research-grade tesamorelin for laboratory use. It is not EGRIFTA, it is not pharmaceutical material, it has no approved indication, and nothing on this site presents it otherwise. We publish this page because the regulatory record is public, frequently misread, and easier to get right than most vendors make it look.

What about Europe and other jurisdictions?

Health Canada’s drug-review agency, CADTH, published a clinical review, a pharmacoeconomic review and a committee recommendation for tesamorelin (Egrifta, Theratechnologies) in 2016 (PMIDs 30920787, 30896905, 30896908); the recommendation record has no abstract in PubMed, so what the committee decided is unverified from that source. The European status is the record’s largest open item: PubMed returns zero records on every European regulatory search term, and PubChem’s EMA Drug Information heading exists but its backing table returns zero rows. No statement about European approval, refusal or withdrawal is made on this page in either direction.

What the research does not show

The approval establishes that a specific product met FDA’s standard for a specific indication, on the trial evidence described elsewhere in this cluster. It does not establish that the compound is safe or effective for any other purpose, in any other population, or in any other form; the controlled human evidence is confined to HIV-associated lipodystrophy. The regulatory record also carries the product’s own stated limit, that long-term cardiovascular safety has not been established. Two facts the primary record does not settle are left unsettled here: European status, and the meaning of the Purple Book’s Disc flag at the presentation level.

Frequently asked questions

So is tesamorelin FDA-approved or not?

A tesamorelin product, EGRIFTA, made by Theratechnologies under application 022505, is FDA-approved for one indication in adults with HIV-associated lipodystrophy. Research-grade tesamorelin is not.

Why can’t I find it in the Orange Book?

It is a Purple Book biologic (351(a), license 2091). The Orange Book does not list it.

Is Artemis Labs’ tesamorelin the same as EGRIFTA?

No. The tesamorelin research page carries the compound’s verified identity record; it is a research reagent, not a pharmaceutical product, and it carries no approval.

When was it first approved?

November 2010, per the Purple Book date 10-Nov-10 and a 2012 review (PMID 22298602). More on the regulatory landscape at our secretagogue research topic page.

References

  1. FDA Purple Book. Tesamorelin, application 022505, as transcribed by PubChem (CID 16137828, Drug and Medication Information). purplebooksearch.fda.gov · pubchem.ncbi.nlm.nih.gov/compound/16137828 (fetched 2026-08-27).
  2. DailyMed label records for EGRIFTA SV (setid 3d783378-b02d-4f19-99dd-0fc91a042224) and EGRIFTA WR (setid 839334d3-8c1d-4c26-9036-2ab524a6ea75), indication field, as transcribed by PubChem. FDA National Drug Code Directory entries 62064-241 and 62064-381.
  3. Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Ann Pharmacother. 2012. PMID 22298602 · DOI.
  4. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024. PMID 38905488 · DOI.
  5. Tesamorelin (Egrifta). Drugs. 2011. PMID 21668043.
  6. CADTH. Clinical Review Report; Pharmacoeconomic Review Report; Canadian Drug Expert Committee Final Recommendation: Tesamorelin (Egrifta). Ottawa, 2016. PMID 30920787 · PMID 30896905 · PMID 30896908.

Methodology: regulatory fields were transcribed from PubChem’s PUG-View record for CID 16137828 (Purple Book, DailyMed, NDC Directory sections) on August 27, 2026, and cross-checked against the cited PubMed records via NCBI E-utilities. Last verified August 28, 2026.

All compounds sold by Artemis Labs are for laboratory research use only. Nothing on this page is medical advice, and no statement has been evaluated by the FDA.

Kate Cai