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DRUG:

safusidenib (AB-218)

i
Other names: AB-218, DS 1001, DS-1001b, DS-1001
Associations
Company:
Baoyuan Biopharma, Daiichi Sankyo
Drug class:
IDH1 inhibitor
Associations
1m
AB-218-IIT-201: A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Melbourne Health | Recruiting --> Active, not recruiting
Enrollment closed
|
LY3295668 • safusidenib (AB-218)
5ms
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial primary completion date: Sep 2023 --> Mar 2023
Trial primary completion date
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • IDH1 R132
|
safusidenib (AB-218)
5ms
IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor (clinicaltrials.gov)
P1, N=63, Recruiting, AnHeart Therapeutics Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation
|
safusidenib (AB-218)
9ms
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial primary completion date: Jun 2023 --> Sep 2023
Trial primary completion date
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • IDH1 R132
|
safusidenib (AB-218)
12ms
Safusidenib Phase 2 Study in IDH1 Mutant Glioma (clinicaltrials.gov)
P2, N=95, Recruiting, AnHeart Therapeutics Inc. | Not yet recruiting --> Recruiting | Trial completion date: Feb 2027 --> Jul 2027 | Trial primary completion date: Jan 2026 --> Mar 2027
Enrollment open • Trial completion date • Trial primary completion date
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 R132H • IDH1 R132C • IDH1 R132
|
LY3295668 • safusidenib (AB-218)
1year
New P1 trial • Metastases
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation
|
safusidenib (AB-218)
2years
New P2 trial
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
|
IDH1 mutation • CDKN2A deletion
|
safusidenib (AB-218)
3years
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
P=N/A, N=47, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial completion date: Mar 2022 --> Mar 2026 | Trial primary completion date: Jan 2022 --> Jan 2021
Clinical • Trial completion date • Trial primary completion date
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
safusidenib (AB-218)
over3years
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (clinicaltrials.gov)
P2, N=25, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Recruiting --> Active, not recruiting
Clinical • Enrollment closed
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation
|
safusidenib (AB-218)
almost4years
Clinical • Enrollment open
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation
|
safusidenib (AB-218)
almost4years
Clinical • New P2 trial
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation
|
safusidenib (AB-218)
4years
Selective inhibition of mutant IDH1 by DS-1001b ameliorates aberrant histone modifications and impairs tumor activity in chondrosarcoma. (PubMed, Oncogene)
DS-1001b treatment reversed the epigenetic changes caused by aberrant histone modifications. The present data strongly suggest that inhibition of mutant IDH1 is a promising therapeutic approach in chondrosarcoma, particularly for the treatment of relapsed or dedifferentiated chondrosarcoma.
Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
safusidenib (AB-218)
4years
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
P=N/A, N=60, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Trial completion date: Mar 2020 --> Mar 2022 | Trial primary completion date: Jan 2020 --> Jan 2022
Clinical • Trial completion date • Trial primary completion date
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
safusidenib (AB-218)