imatinib
imatinib: sourced relationships with 5 companies · 21 clinical trials tracked · 2 FDA decisions.
imatinib evidence translation
What we can confirm
2 FDA records · 21 tracked trials
What it means
What to watch
Prepared research question
What is verified about imatinib, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 3 study sponsors
Related indications
Dated Pipeline Records (5)
| Company | Dated record stage |
|---|---|
| Amneal Pharmaceuticals, Inc. (AMRX) Reported 2019-02-08 · Current development: unknownSource | Approved |
| Jade Biosciences, Inc. (JBIO) | Preclinical |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2018-08-13 · Current development: unknownSource | Approved |
| TENAX THERAPEUTICS, INC. (TENX) pulmonary arterial hypertension ("PAH") | Preclinical |
| Vistagen Therapeutics, Inc. (VTGN) levodopa-induced dyskinesia (LID) and neuropathic pain (NP);… | Preclinical |
Clinical Trial Registry Records (21)showing 10 most recent
Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)
Primary endpoint: Morphological relapse-free survival (M-RFS)
An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia
Primary endpoint: Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)
A Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
Primary endpoint: Dose Escalation: Dose Limiting Toxicity (DLT)
A Phase 3, Multicenter, Randomized, Open-Label, Trial Evaluating the Efficacy and Safety of Asciminib Used in Consolidation With Imatinib v. Imatinib to Achieve Treatment-free Remission in Chronic Phase-Chronic Myelogenous Leukemia Patients
Primary endpoint: Event-free survival rate
A Dose Calibration and Dose Equivalence Pharmacokinetic Study in Healthy Volunteers Comparing IkT-001Pro to Imatinib Mesylate 400mg
Primary endpoint: Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC(0-last))
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Primary endpoint: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Primary endpoint: One-year "second" treatment-free remission.
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Primary endpoint: Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma
Primary endpoint: Objective response rate (ORR)
ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)
Primary endpoint: Event-free survival (EFS) for the whole protocol
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with imatinib?
imatinib has dated SEC/FDA relationship records for Amneal Pharmaceuticals, Inc., Jade Biosciences, Inc., DR REDDYS LABORATORIES LTD and 2 others.
How many clinical trials involve imatinib?
BioSniper tracks 21 clinical trials involving imatinib.
What is imatinib's latest FDA decision?
The most recent tracked FDA decision for imatinib is Approval for 1 INDICATIONS AND USAGE Imatinib mesylate is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 ) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2 ) • Adult patients with relapsed or refractory Philadelp, dated February 8, 2019.