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DRUG:

flonoltinib

Associations
Company:
Baoling Bio
Drug class:
JAK2 inhibitor, FLT3 inhibitor, CDK6 inhibitor
Related drugs:
Associations
4d
Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. (PubMed, Ther Adv Hematol)
The FMF-02 trial is the first randomized phase IIb study directly comparing the novel inhibitor FM against RUX. Its findings are expected to generate pivotal evidence regarding whether FM offers superior or differentiated clinical benefits, thereby informing its potential as a frontline therapy for intermediate- to high-risk MF and guiding the design of future phase III studies.
P2b data • Journal
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JAK2 (Janus kinase 2) • CDK6 (Cyclin-dependent kinase 6)
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Jakafi (ruxolitinib) • flonoltinib
25d
Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera (clinicaltrials.gov)
P2, N=60, Recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd | Active, not recruiting --> Recruiting
Enrollment open • Tumor mutational burden
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hydroxyurea • flonoltinib
25d
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis (clinicaltrials.gov)
P3, N=105, Recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open
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Jakafi (ruxolitinib) • flonoltinib
27d
New P2 trial
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flonoltinib
2ms
Phase IIa study on the safety and efficacy of Flonoltinib Maleate Tablets in the treatment of patients with polycythemia vera (ChiCTR2500111413)
P2, N=60, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS);West China Hospital of Sichuan University;Shengjin
New P2 trial
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hydroxyurea • flonoltinib
2ms
An open-label, positive drug-controlled, parallel-group, multicenter phase II clinical trial on the efficacy, safety and pharmacokinetics of flonoltinib maleate tablet in patients with intermediate and high-risk myelofibrosis (ChiCTR2500115640)
P2, N=75, Completed, Institute of Hematology, Chinese Academy of Medical Sciences / West China Hospital of Sichuan University; Chengdu Zenitar Biomedical Technology Co., L
New P2 trial
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flonoltinib
2ms
Food Effect Study in Healthy Volunteers of Phase I Flonoltinib Maleate (ChiCTR2500115039)
P1, N=24, Completed, Chengdu Xinhua Hospital; Chengdu Zenitar Biomedical Technology Co.Ltd.
New P1 trial
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flonoltinib
3ms
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis (clinicaltrials.gov)
P3, N=105, Not yet recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd
New P3 trial
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Jakafi (ruxolitinib) • flonoltinib
4ms
Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd
New P2 trial • Tumor mutational burden
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hydroxyurea • flonoltinib
6ms
Safety of Flonoltinib Maleate Tablets for the Treatment of Patients With Myeloproliferative (clinicaltrials.gov)
P1/2, N=31, Completed, Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting --> Completed | Trial completion date: Dec 2023 --> Mar 2025
Trial completion • Trial completion date
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flonoltinib
6ms
A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets (clinicaltrials.gov)
P1, N=24, Completed, Chengdu Zenitar Biomedical Technology Co., Ltd
New P1 trial
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flonoltinib
6ms
A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects (clinicaltrials.gov)
P1, N=40, Completed, Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting --> Completed
Trial completion
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flonoltinib