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Regulatory Status Table

Verified October 30, 2026
Medication / program Status Notes
Retatrutide Investigational; not approved anywhere Re-verified in Lilly’s Oct 28 release: “investigational molecule,” not approved by FDA or any regulator. The release states no regulatory submission or timing (“if approved”). The Oct 16 issue carried Lilly’s earlier stated plan to file in Q1 2027; this was not re-confirmed. Cannot be legally prescribed or compounded.
Wegovy pill (oral semaglutide 25 mg) Approved, on market Carried forward (FDA approval announced by Novo Nordisk Dec 22, 2025; available since January 2026).
Foundayo (orforglipron) Approved, on market Re-verified indirectly: Lilly’s Q3 release reports Foundayo revenue of $184 million in Q3 2026 ($281 million year to date) and “global launches.” The release does not give approval dates; approval on April 1, 2026 is carried forward.
CagriSema Under FDA review Submitted Dec 18, 2025; Novo guides to a Q4 2026 decision; no public PDUFA date found (status guide, last verified July 15, 2026). No approval turned up in Oct 30 searches. REDEFINE 4 (Feb 23, 2026) missed non-inferiority against tirzepatide: 23.0% vs 25.5% (efficacy) and 20.2% vs 23.6% (treatment-policy) per the same guide. The status source is secondary and dated; re-confirm before publishing.
Petrelintide Investigational (Phase 2 complete) Carried forward from the Oct 16 issue.
Medicare GLP-1 Bridge Active July 1, 2026 – Dec 31, 2027 Carried forward from Oct 13 (CMS). Not re-opened this week. Medicare open enrollment runs Oct 15 – Dec 7.