Will the FDA accept the retatrutide NDA filing in obesity before 30 September 2027?
deadline 2027-09-30
confidence high
tier 2 evidence
85%Asturna estimate
Resolution criterion
Yes if Lilly publicly announces the FDA's acceptance of the application, or if a PDUFA date is published, by 30 September 2027. Submission alone, without acceptance, is not sufficient.
Verified starting state
Lilly is targeting a filing in the first quarter of 2027, having pushed back an initial 2026 target for lack of sufficient manufacturing and quality control data. TRIUMPH-1: roughly 30% weight loss at 104 weeks. Formal acceptance comes about 60 days after a submission whose date remains indicative. (23 July 2026)
What pushes it up
- Phase 3 TRIUMPH-1 data shows industry-leading 30% weight loss, providing a strong clinical basis for the NDA [Hand-verified]
- Lilly is actively presenting full Phase 3 data, indicating the clinical package is maturing [5]
- The company is already implementing early access programs, suggesting high confidence in the drug's profile [10, 11]
What pushes it down
- The filing target has already been delayed once from 2026 to Q1 2027 due to manufacturing and quality control data needs [Hand-verified]
- The resolution requires FDA acceptance, which typically takes 60 days after the submission date, narrowing the window for any further delays [Hand-verified]
What would move this number most
The potential for further manufacturing or quality control data delays, which have already pushed the filing target back once.
How this number is built
| Deadline | 2027-09-30 |
| Base rate | 90% |
| Best evidence | tier 2 · 3 article(s) used |
| Independent runs | 84 · 85 (spread 1 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-10-09 09:05 |
| Model | gemini-3-flash-preview |
Sources consulted
Probability history
2026-10-09 09:05 85% 50 article(s) on file · gemini-3-flash-preview
- What pushes it up. Phase 3 TRIUMPH-1 data shows industry-leading 30% weight loss, providing a strong clinical basis for the NDA [Hand-verified]
- What pushes it up. Lilly is actively presenting full Phase 3 data, indicating the clinical package is maturing [5]
- What pushes it up. The company is already implementing early access programs, suggesting high confidence in the drug's profile [10, 11]
- What pushes it down. The filing target has already been delayed once from 2026 to Q1 2027 due to manufacturing and quality control data needs [Hand-verified]
- What pushes it down. The resolution requires FDA acceptance, which typically takes 60 days after the submission date, narrowing the window for any further delays [Hand-verified]
- What would move this number most. The potential for further manufacturing or quality control data delays, which have already pushed the filing target back once.
2026-09-26 09:19 77% 23 article(s) on file · openai/gpt-oss-120b (Groq)
- What pushes it up. Lilly publicly stated it will file for approval of its next‑generation obesity drug in 2027 as it clears two more trials [tier 2]
- What pushes it up. Lilly plans to offer early access to the drug, indicating confidence in the pending submission [tier 2]
- What pushes it up. Announcement of special access program shows regulatory engagement and progress [tier 2]
- What pushes it down. Report that Lilly cancelled an early experimental obesity drug after a ‘high bar’ was not met, suggesting possible development setbacks that could delay filing [tier 2]
- What pushes it down. Tier‑4 article about halting development after a phase‑1 setback (unconfirmed) adds uncertainty
- What would move this number most. The actual filing date – whether Lilly files in Q1 2027 as planned or experiences further delays
2026-09-20 09:03 85% 15 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).