Tesamorelin: FDA and compounding status

Quick answer

Tesamorelin is an FDA-approved drug and is not on FDA's 503A Bulks List. Section 503A records it as "Not nominated" (May 14, 2026) and section 503B as "Not nominated" (March 21, 2025). No PCAC recommendation is on file and the committee is advisory; verified September 16, 2026.

By Peptides.NYC Editorial TeamPublished September 16, 2026

Verified against FDA's bulk substances page on September 16, 2026. Every field below links the document it came from.

Current status

Tesamorelin

FDA approval

FDA approved

FDA approved EGRIFTA (tesamorelin acetate) under application 022505 on November 10, 2010. Drugs@FDA records that the former NDA was deemed to be a BLA on March 23, 2020.

Sources

Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503A

Not nominated

As stated on the cited document, dated May 14, 2026.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503B

Not nominated

As stated on the cited document, dated March 21, 2025.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Verified against FDA's bulk substances page on September 16, 2026.

Timeline

Every dated event on file for Tesamorelin, newest first, with the document it came from.

March 23, 2020Status change
The EGRIFTA application was deemed to be a biologics license application.
Sources
- Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate) (U.S. Food and Drug Administration, retrieved 2026-09-16)
November 10, 2010Status change
FDA approved EGRIFTA (tesamorelin acetate) under application 022505.
Sources
- Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Related guides

Frequently asked questions

Is Tesamorelin legal to compound?

On FDA's section 503A list, Tesamorelin is recorded as "Not nominated" as of May 14, 2026. On FDA's section 503B list, Tesamorelin is recorded as "Not nominated" as of March 21, 2025. Tesamorelin is not on FDA's 503A Bulks List: that list is established by notice-and-comment rulemaking, and none of the categories above is inclusion on it. Compounding is governed by federal and state law together, and a pharmacy or outsourcing facility answers to both. This page reports what FDA has published; it is not legal or medical advice.

Was Tesamorelin reviewed by PCAC?

This tracker cites no Pharmacy Compounding Advisory Committee record for Tesamorelin. PCAC's role is advisory: FDA must still complete notice-and-comment rulemaking before anything is added to the 503A Bulks List.

Is Tesamorelin FDA-approved?

FDA approved EGRIFTA (tesamorelin acetate) under application 022505 on November 10, 2010. Drugs@FDA records that the former NDA was deemed to be a BLA on March 23, 2020.

Disclaimer: This page is a record of what regulators have published about Tesamorelin. It is for educational purposes only, it is not medical or legal advice, and it is not a recommendation to use or compound any substance. Regulatory status changes; check the linked primary sources and consult your healthcare provider.