Phase 2 Trial TQ05105 Tablets Myelofibrosis
Summary
The NIH has registered a Phase 2 clinical trial (NCT07551427) evaluating TQ05105 Tablets (Rovadicitinib Tablets) in subjects with intermediate/high-risk myelofibrosis. The open-label, single-arm, multi-center study comprises two cohorts: Cohort 1 assesses pharmacokinetics in participants with normal, mild, or moderate renal impairment to guide dosing, while Cohort 2 evaluates efficacy and safety in participants who are refractory, relapsed, or intolerant to prior JAK inhibitor therapy. The trial is registered as of April 24, 2026.
“Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.”
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What changed
NIH registered a Phase 2 clinical trial (NCT07551427) for TQ05105 Tablets (Rovadicitinib) in myelofibrosis on April 24, 2026. The trial is open-label, single-arm, and multi-center, with two cohorts: one evaluating pharmacokinetics across renal impairment levels and another assessing efficacy and safety in JAK inhibitor-refractory patients.
For clinical investigators and pharmaceutical companies, this trial registration signals an active oncology drug development program targeting myelofibrosis. The pharmacokinetic cohort design suggests the sponsor is actively characterising renal dosing implications, which may inform future label submissions. Patients with intermediate/high-risk myelofibrosis who have exhausted JAK inhibitor options may seek investigator contact for potential enrolment.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
Phase 2 NCT07551427 Kind: PHASE2 Apr 24, 2026
Abstract
This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.
Conditions: Myelofibrosis
Interventions: TQ05105 Tablets (Rovadicitinib Tablets)
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