RESEARCH ARCHIVE · DRAFT EDITORIAL COPY

Retatrutide milestones archive.

Prepared September 15, 2026 · Publisher review required · No clinician review claimed

A dated, source-linked record of retatrutide research and sponsor announcements. Each entry has a publication date, a retrieval date, and a source. Where the source is a sponsor statement, that is noted; where it is a peer-reviewed publication, the journal is named.

This archive records what was published, by whom, and when. It is not a meta-analysis, not a clinical recommendation, and not a forecast. Where a research milestone has later been superseded, corrected, or contested, the entry is annotated; an outright retraction or correction is recorded with its own entry.

Foundational research

2023 — Phase 2 obesity topline results (SURMOUNT-1 and earlier Phase 2 cohorts)

Lilly announced Phase 2 topline results for retatrutide in adults with obesity. The publication context (NEJM) and reported endpoints are documented in Lilly’s investor communications. Publication: 2023 (Lilly press release / NEJM paper, June 26, 2023) · Checked: 2026-09-15 S07: ClinicalTrials.gov retatrutide search

2024 — Phase 3 program initiation (TRIUMPH program)

Lilly initiated the TRIUMPH Phase 3 program covering multiple obesity-related cohorts. Specific trial identifiers and primary endpoints are recorded in ClinicalTrials.gov. Publication: 2024 (ClinicalTrials.gov entries, individual dates) · Checked: 2026-09-15 S07: ClinicalTrials.gov retatrutide search

Sponsor announcements (2026)

July 23, 2026 — TRIUMPH-2 and TRIUMPH-3 topline results

Lilly announced topline results from the TRIUMPH-2 and TRIUMPH-3 Phase 3 trials. A sponsor announcement is not an FDA determination. The publication context of full results and any peer-reviewed write-up is separate from the topline summary. Publication: 2026-07-23 (Lilly investor release) · Checked: 2026-09-15 S03: Retatrutide successful in two additional Phase 3 obesity trials

August 5, 2026 — Q2 2026 results + planned Q1 2027 submission

Lilly’s Q2 2026 results announcement describes plans to submit a retatrutide Biologics License Application (BLA) in Q1 2027. The statement is filed as Exhibit 99.1 with the SEC; the SEC preserves the statement but does not confirm the medical or regulatory outcome. Publication: 2026-08-05 (SEC archive) · Checked: 2026-09-15 S02: Second-quarter 2026 results, Exhibit 99.1

FDA framework updates (2023–2027)

PDUFA VII performance goals (current framework)

The current PDUFA VII framework sets action goals for 90% of original BLAs and NME NDAs: 10 months for standard review and 6 months for priority review, both from the 60-day filing date. Goals are agency-process goals, not approval guarantees. Publication: FY 2023–2027 framework · Checked: 2026-09-15 S04: PDUFA VII performance goals, section I.A.1, printed page 4

Regulatory events specific to retatrutide

No retatrutide-specific FDA submission, filing acceptance, designation, or decision has been confirmed in the sources reviewed for this snapshot. The next entry would be created when such an event occurs and is sourced.

What this archive does not contain

Full clinical study reports, complete trial datasets, peer-reviewed primary papers (only the existence and citation of published work is noted here), pricing information, formulary decisions, and any post-approval commercial milestones. Each of those has separate sources and separate caveats. Pricing and access questions, when relevant, belong in a separate document.

How entries are added

An entry is added when (a) the FDA acts on the application, (b) the sponsor publishes a new primary disclosure, (c) a peer-reviewed paper reports new retatrutide-specific results, or (d) a public health agency issues a substantive statement. Routine secondary coverage, reposts, and speculation are not added. Where a prior entry is superseded, the original entry is annotated and a new entry is added. The archive is appended to; it is not rewritten.

Read without subscribing. Choose an edition only when you wish to receive email.

Explore RetaRegister