TB-500

A thymosin beta-4 fragment studied for tissue repair and recovery. Animal data; no completed human RCTs. Removed from FDA Category 2 in April 2026; PCAC review pending.

Anthivera’s calibrated five-tier scale — what the strongest evidence on TB-500 actually supports today.

1. PreclinicalTB-500
2. Limited clinical
3. Multiple human studies
4. Phase 3
5. FDA-approved

Preclinical: Animal / in vitro / mechanistic data only.

Dated milestones in TB-500’s U.S. regulatory path.

1. Late 2023

   Placed on FDA Category 2 (do-not-compound list), restricting compounding-pharmacy access.

2. April 23, 2026

   Removed from FDA Category 2 compounding list. Removal is NOT the same as Category 1 status or FDA approval.

3. July 23–24, 2026

   Pharmacy Compounding Advisory Committee (PCAC) review scheduled to evaluate inclusion on the 503A Bulks List.

1. 01What evidence is there for TB-500 in women specifically — and does that include perimenopausal or postmenopausal cohorts?
2. 02What is the current FDA regulatory status, and which compounding pharmacy will my prescription go through?
3. 03What baseline labs do you require before starting, and how often do you monitor?
4. 04What are the realistic timelines and what does “not working for you” look like in practice?

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