Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07401823 | Open-Label Extension Study to Pioneer Study 6058-SCD-101 | PHASE2 | ENROLLING BY_INVITATION | 50 | — | — | Mar 30, 2026 | Jul 5, 2030 | Apr 14, 2026 | 8 | United States |
| NCT07431398 | Single-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell Disease | PHASE1 | RECRUITING | 24 | — | — | Dec 13, 2025 | Jun 1, 2026 | Mar 30, 2026 | 6 | United States |
| NCT05169580 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pociredir | PHASE1 | COMPLETED | 45 | — | — | Dec 13, 2021 | Jan 20, 2026 | Feb 12, 2026 | 18 | United States, Nigeria +1 |
Laboratory assessments including hematology, coagulation, serum chemistry and electrolytes, lipid panel, SCD characterization, serology, urinalysis and pregnancy tests will be performed.
To evaluate the safety and tolerability of Pociredir in adult participants with sickle cell disease based on the frequency of adverse events (AEs) and changes in clinically significant laboratory test results, vital signs and electrocardiograms (ECGs) parameters.
Blood samples will be collected to measure the plasma concentration of Pociredir at specified timepoints.
| Arm | Type | Description |
|---|---|---|
| Pociredir | EXPERIMENTAL | Participants will receive Pociredir orally once daily (QD) |
| Fasted Cohort | EXPERIMENTAL | Pociredir single dose tablet formulation under fasted conditions. |
| Fed Cohort | EXPERIMENTAL | Pociredir single dose tablet formulation under fed conditions (after a high-fat breakfast). |
| Pociredir oral capsule(s) in Sickle Cell participants | EXPERIMENTAL | Cohort 1 will receive 6 mg of Pociredir by mouth once daily. Cohort 2 will be dosed at 2 mg once daily by mouth, and cohort 3 will be dosed at 12 mg once daily by mouth. The Sponsor will reinitiate enrolment in the 3rd cohort (12 mg cohort) with the updated inclusion and exclusion criteria. Based on review of available safety and biomarker data and with the recommendation of the DMC, a subsequent 4th cohort of 20 mg and potentially a 5th cohort of 30 mg may be initiated. A total of seven cohorts may be included. Following the first cohort, doses for all subsequent cohorts will be determined following DMC review of the safety and pharmacokinetic data observed in participants from the prior and ongoing cohorts. Alternate dosing schedules may be evaluated in some of the cohorts. |
| Name | Type | Description |
|---|---|---|
| Pociredir | DRUG | Pociredir Oral Capsules will be administered |
| Pociredir oral capsule(s) | DRUG | Participants will receive Pociredir |
Inclusion Criteria: * Participants aged ≥18 years and older must have previously participated in and successfully completed Study 6058-SCD-101. * Participant has signed and dated the informed consent form (ICF) before any study-specific procedures are performed and is willing and able to comply wit...