Initiate the Phase 3 SERENE clinical study
Not delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 11 Feb 2021
- Due
- 30 Jun 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Myovant and Pfizer plan to initiate in the first half of calendar year 2021 a Phase 3 open-label clinical study in the U.S. to assess the contraceptive efficacy of relugolix combination tablet.”
What we found
Evidence strength A What the grades mean
The company failed to initiate the SERENE study by the first half of 2021, as the FDA placed a partial clinical hold on the study in May 2021, which was not lifted until August 2021.
-
A Myovant Sciences Ltd. 10-Q filed 2021-07-28
“on May 18, 2021, the FDA informed us by teleconference that it placed a partial clinical hold on the Phase 3 SERENE study (MVT-601-050) evaluating relugolix combination tablet for the prevention of pregnancy pending amendment of the study protocol.” ✓ confirmed on the page
-
A Myovant Sciences Ltd. 10-Q filed 2021-10-26
“In August 2021, the FDA informed us that the partial clinical hold on such study was lifted following study protocol amendments.” ✓ confirmed on the page
Checked 25 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Clinical milestone
- Indicative materiality
- Medium rules
- Action
- Initiate
- Deliverable
- Phase 3 SERENE study
- Where
- U.S.
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Partner
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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