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Ascendis Pharma A/S

File CTN to initiate adult hypoparathyroidism phase 3 trial in Japan

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
10 Mar 2021
Due
30 Jun 2021
Delivered
Q2 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“On track to file CTN to initiate adult HP phase 3 trial in Japan in the second quarter of 2021.”

What we found

Evidence strength A What the grades mean

A later 20-F says the CTN for the PaTHway Japan Trial was submitted in Q2 2021, within the deadline; PMDA acceptance followed in July 2021.

  • A
    Ascendis Pharma A/S 6-K filed 2021-07-06 Regulatory filing · published 6 Jul 2021 · retrieved 27 Oct 2026 · kept permanently by the SEC
    “The Company also announced the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) acceptance of the clinical trial notification for the PaTHway Japan Trial” ✓ confirmed on the page
  • A
    Ascendis Pharma A/S 20-F filed 2022-03-02 Regulatory filing · published 2 Mar 2022 · retrieved 27 Oct 2026 · kept permanently by the SEC
    “In the second quarter of 2021, we submitted a Clinical Trial Notification (“CTN”) to the MHLW for PaTHway Japan Trial, a Phase 3 trial to evaluate the safety, tolerability, and efficacy of TransCon PTH.” ✓ confirmed on the page

Checked 27 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
File
Deliverable
CTN filing for adult HP phase 3 trial in Japan
Where
Japan
Language
Firm (“will”, “on track to”)
In the company’s control
High
Specificity
High

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Claude (Anthropic), 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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Report an error in this entry Reference: KI-C-2021-ASND-025539 · Corrections policy

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