Clinical Trial Updates (SCD)
Osivelotor
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Product Information
Scientific name: Osivelotor
Brand name: Ν/Α
RESPONSIBLE: Pfizer Inc. -
Clinical Trial/Study Information
Trial Name: –
Code: NCT05431088
Phase: 2/3
Eligible patient diagnosis: : SCD
No. of Patients enrolled: 429 (Last update: 11/12/2024)
Study Sites: 52 Sites per countryCompletion date: October 2026
Scope of the Study / Aim: Evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor -
Regulatory Information
Status: Not Authorised
Additional notable points:
- EMA: N/A
- FDA: N/A
- MHRA: N/A
No update available.
Update: 19 December 2024
No update available.
Update: 30 September 2024
No update available.
Update: 30 June 2024
- Data presented at the 29th EHA Annual Congress (13 – 16 June 2024) in Madrid (Spain) from Part A (dose-finding) of the 3-part phase 2/3 trial for the oral HbS polymerisation inhibitor osivelotor in patients with SCD showed that:
– 35 patients had been treated by the cut-off date of 20 June 2023.
– Increases in haemoglobin from baseline were observed and maintained from week 1 to week 12.
