Delving into the Latest Updates on Vodobatinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [3]

Target

Bcr-Abl

Mechanism

Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesImmune System Diseases+ [1]

Active Indication

Philadelphia chromosome positive chronic myelogenous leukemiarefractory chronic myelocytic leukemiaChronic phase chronic myeloid leukemia+ [2]

Inactive Indication

Lewy Body DiseaseYoung onset Parkinson disease

Originator Organization

Sun Pharma Advanced Research Co. Ltd.

Active Organization

Sun Pharma Advanced Research Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (EU)

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Structure/Sequence

Molecular FormulaC27H20ClN3O2

InChIKeyZQOBVMHBVWNVBG-UHFFFAOYSA-N

CAS Registry1388803-90-4

This study evaluates the safety and tolerability of treatment with K0706 in Dementia with Lewy Bodies (DLB).
The hypothesis is that K0706 will be safe and tolerable and that this drug will alter CSF and plasma biomarkers in DLB. Clinical assessments of cognitive, behavioral and motor functioning will also be evaluated. A total of 45 participants will be randomized 1:1:1 into 3 groups (n=15/per group) to be treated with sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) or sachet of 384 mg powder of K0706 (equivalent to 192 capsule of K0706) or sachet of matching placebo ( equivalent to a capsule of placebo) for 12 weeks, followed by 4-week wash-out period.

Start Date05 Sep 2019

Sponsor / Collaborator

Georgetown University

[+1]

NCT03655236

/ TerminatedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease

This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1

Start Date18 Feb 2019

Sponsor / Collaborator

Sun Pharma Advanced Research Co. Ltd.

100 Clinical Results associated with Vodobatinib

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100 Translational Medicine associated with Vodobatinib

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100 Patents (Medical) associated with Vodobatinib

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8

Literatures (Medical) associated with Vodobatinib

01 Feb 2025·European Journal of Pharmacology

Vodobatinib overcomes cancer multidrug resistance by attenuating the drug efflux function of ABCB1 and ABCG2

Article

Author: Wu, Yu-Shan ; Hung, Tai-Ho ; Murakami, Megumi ; Chen, Chin-Chuan ; Wu, Chung-Pu ; Li, Yen-Ching ; Lin, Bing-Huan ; Ambudkar, Suresh V

Multidrug resistance (MDR) remains a significant obstacle in cancer treatment, primarily attributable to the overexpression of ATP-binding cassette (ABC) transporters such as ABCB1 and ABCG2 within cancer cells. These transporters actively diminish the effectiveness of cytotoxic drugs by facilitating ATP hydrolysis-dependent drug efflux, thereby reducing intracellular drug accumulation. Given the absence of approved treatments for multidrug-resistant cancers and the established benefits of combining tyrosine kinase inhibitors (TKIs) with conventional anticancer drugs, we investigate the potential of vodobatinib, a potent c-Abl TKI presently in clinical trials, to restore sensitivity to chemotherapeutic agents in multidrug-resistant cancer cells overexpressing ABCB1 and ABCG2. Results indicate that vodobatinib, administered at sub-toxic concentrations, effectively restores the sensitivity of multidrug-resistant cancer cells to cytotoxic drugs in a concentration-dependent manner. Moreover, vodobatinib enhances drug-induced apoptosis in these cells by inhibiting the drug-efflux function of ABCB1 and ABCG2, while maintaining their expression levels. Moreover, we found that while vodobatinib enhances the ATPase activity of ABCB1 and ABCG2, the overexpression of these transporters does not induce resistance to vodobatinib. These results strongly suggest that increased levels of ABCB1 or ABCG2 are unlikely to play a significant role in the development of resistance to vodobatinib in cancer patients. Overall, our findings unveil an additional pharmacological facet of vodobatinib against ABCB1 and ABCG2 activity, suggesting its potential incorporation into combination therapy for a specific subset of patients with tumors characterized by high ABCB1 or ABCG2 levels. Further investigation is warranted to fully elucidate the clinical implications of this therapeutic approach.

01 Feb 2025·Biomedical Chromatography

Validated HPLC‐UV Method for the Quantification of a Novel BCr‐Abl 1 Inhibitor, Vodobatinib, in Rat Plasma: Application to a Pharmacokinetic Study

Article

Author: Bestha, Rama Murthi ; Dittakavi, Sreekanth ; Kumar, Rajnish ; Veerla, Niranjan ; Madipelli, Keerthana ; Mullangi, Ramesh ; Kaddare, Sandeep ; Biradar, Yogesh Balaji ; Zakkula, Ashok

ABSTRACTVodobatinib is a Bcr‐Abl 1 inhibitor, currently entering into Phase 2 clinical trials as a potential drug to treat glioblastoma patients. In the present work, a validated high‐performance liquid chromatography (HPLC) detection method for the quantification of vodobatinib in rat plasma was established. Sample preparation involved liquid–liquid extraction method. The chromatographic separation of vodobatinib and the IS was accomplished on an XBridge C18 column using 10 mM ammonium acetate and acetonitrile in gradient condition. The flow‐rate and injection volume were 0.8 mL/min and 20 μL, respectively. The eluent was detected at 310 nm. Vodobatinib and the IS eluted at 7.5 and 5.9 min, respectively, with a total run time of 10 min. Validation tests were performed according to FDA requirements. The established method showed good linearity in the range of 50.5–6534 ng/mL. Interday and intraday coefficients of variations were < 5.11%. Stability studies, dilution integrity, and incurred sample reanalysis met the acceptance criteria. Subsequently, the validated HPLC method was used to study the disposition kinetics of vodobatinib in rats.

01 Jun 2023·Clinical lymphoma, myeloma & leukemia

Management of Chronic Myeloid Leukemia Patients in Later Lines: The Role of Ponatinib and New Compounds.

Review

Author: Martelli, Maurizio ; Costa, Alessandro ; Scalzulli, Emilia ; Carmosino, Ida ; Breccia, Massimo ; Bisegna, Maria Laura

Limited therapeutic options and poor response probability still represent some unresolved issue in later lines chronic myeloid leukemia (CML) patients. In addition, sequential treatment is associated with reduced overall survival and may select new mutation, including the T315I, further reducing the therapeutic chances: outside the United States, ponatinib and allogenic stem cell transplant are the only available options. In the last decade, ponatinib improved outcomes in third-line patients, although limited by the risk of severe adverse occlusive events. Dose optimization strategies with lower doses of ponatinib in selected patients have shown to reduce toxicity while retaining efficacy, but higher doses are needed in T315I patients for an adequate disease control. Recently approved by FDA, the first-of-its-kind STAMP inhibitor asciminib has proven safe and effective, obtaining deep and stable molecular responses even in heavily pretreated patients and with T315I mutation. Unfortunately, a significant proportion of patients remain intolerant or refractory, making it crucial to develop new therapeutic options. Among these, novel agents such as vodobatinib and olverembatinib have provided promising result in clinical trials, representing valuable therapeutic possibilities in intolerant or refractory patients. Therefore, a more complex therapeutic paradigm is expected in the near future.

100 Deals associated with Vodobatinib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Philadelphia positive acute lymphocytic leukaemia	Phase 2	ES	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	GB	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	KR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	HU	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	FR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	TR	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	IT	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	BE	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
Philadelphia positive acute lymphocytic leukaemia	Phase 2	US	Sun Pharma Advanced Research Co. Ltd.	27 Jun 2016
refractory chronic myelocytic leukemia	Phase 2	US	Sun Pharma Advanced Research Co. Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02629692 (ASH 12021 \| ASH 22021) Manual	Phase 1	Philadelphia positive acute lymphocytic leukaemia \| Philadelphia chromosome positive chronic myelogenous leukemia Last line Philadelphia Chromosome Positive	52	vodobatinib (dose-escalation (DEs))	(drrajhxaan) = Nineteen pts (37%) reported SAEs; vodobatinib related SAEs were reported in 3 pts (fatal intracranial haemorrhage (ICH), Grade 2 back pain and Grade 3 amnesia reported in 1 pt each) lxgtnfujds (rdbyqkesbe ) View more	Positive	05 Nov 2021
				vodobatinib 174 mg (dose-expansion (DEx))