nilotinib
nilotinib: sourced relationships with 2 companies · 17 clinical trials tracked · 2 FDA decisions.
nilotinib evidence translation
What we can confirm
2 FDA records · 17 tracked trials
What it means
What to watch
Prepared research question
What is verified about nilotinib, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| Novartis AG (NVS) Reported 2007-10-29 · Current development: unknownSource | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2025-11-19 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (17)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)
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
Primary endpoint: Accrual of patients to ComboMATCH treatment trials
A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.
Primary endpoint: Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)
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)
A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
Primary endpoint: Percentage of Patients Experiencing Dose Limiting Toxicities
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
Frontline Asciminib Combination in Chronic Phase CML
Primary endpoint: deep molecular response (Rate of MR4)
Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
Primary endpoint: Proportion of patients on tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD)
A Phase II, Single-arm Study of De-escalation and Treatment-free Remission in Patients With Chronic Myeloid Leukemia Treated With Nilotinib in First-line Therapy Followed by a Second Attempt After Nilotinib and Asciminib Combination: DANTE Study
Primary endpoint: Percentage of patients in full treatment-free remission 96 weeks after the start of the consolidation period of TFR1 stage
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with nilotinib?
nilotinib has dated SEC/FDA relationship records for Novartis AG, DR REDDYS LABORATORIES LTD.
How many clinical trials involve nilotinib?
BioSniper tracks 17 clinical trials involving nilotinib.
What is nilotinib's latest FDA decision?
The most recent tracked FDA decision for nilotinib is Approval, dated November 19, 2025.