What moved in the GLP-1 records, September 2026

The FDA label for tirzepatide (NDA215866) now covers cardiovascular disease. It did not the previous time this site read it; the change was recorded on 3 September 2026. A label is the regulator's own record of what a drug may be used for, and it usually moves before the corresponding Drugs@FDA submission appears.

That is one of 57 changes this site recorded to GLP-1 trial, approval and supply records over 30 days. The rest, with the previous value of each field, follows.

Approved indications

• tirzepatide (NDA215866) added cardiovascular disease — what the label said before

Readout dates

14 scheduled completion dates moved: 9 slipped and 5 came forward. A date coming forward is the less common direction and is worth noting; the registry records the movement, never the reason.

• semaglutide, P2: 2031-09-30 → 2028-10-31 (35 months earlier) — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke…
• semaglutide, P2: 2027-09-20 → 2026-01-20 (20 months earlier) — Efficacy and Safety of Empagliflozin or Semaglutide in…
• semaglutide, P4: 2026-07-31 → 2027-10-31 (15 months later) — Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer…
• tirzepatide, P2: 2028-12-31 → 2029-10-31 (10 months later) — A Study of Weight Loss Intervention With Tirzepatide and Progestin…
• semaglutide, P3: 2029-06 → 2030-03 (9 months later) — Semaglutide for the Treatment of Glucose Intolerance in Women With…
• semaglutide, P2: 2026-07 → 2027-01 (6 months later) — Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With…
• semaglutide, P2: 2026-12 → 2027-05 (5 months later) — A Study of LY3457263 Compared With Placebo in Participants With Type…
• semaglutide, P3: 2026-07 → 2026-12 (5 months later) — Semaglutide for Smoking Cessation in Patients With Diabetes

No tracked trial was terminated, suspended or withdrawn in this period, which is worth stating because it is the kind of absence a monthly count hides.

Which programmes moved most

As a share of each drug’s own registered trials, rather than a raw count — semaglutide will always top a raw count because it has the most trials on file.

• mazdutide: 2 of 18 trials changed a tracked field (11%)
• maridebart cafraglutide: 1 of 13 trials changed a tracked field (8%)
• semaglutide: 18 of 410 trials changed a tracked field (4%)
• tirzepatide: 6 of 140 trials changed a tracked field (4%)
• orforglipron: 1 of 27 trials changed a tracked field (4%)

Small denominators move sharply on one or two changes, so treat the tail of that list lightly.

Every item links to the observation it came from, and each of those to the source record. The previous values are not recoverable from ClinicalTrials.gov or the FDA, which revise in place; they exist here because this site compares each fetch against the last.