Tasigna

(Nilotinib)

ApprovedProtein / enzyme

Nilotinib is used to treat certain types of blood cancer, specifically chronic myeloid leukemia (CML), which is a cancer of white blood cells that grow too quickly in the bone marrow.[2] Tasigna is currently approved and in use across 27 indications[4].[1]

Tasigna is one of 435 small molecule programs targeting Gastrointestinal Stromal Tumor. It is currently in Approved.

Indications

158

Total Trials

Active Trials

434

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Gastrointestinal Stromal TumorTerminated

Chronic Myelogenous LeukemiaCompleted

Systemic MastocytosisActive, not recruiting

Breast CancerApproved

Stem Cell TransplantNot yet recruiting

Low Grade GliomaApproved

Tenosynovial Giant Cell Tumor, Diffuse TypeApproved

Alzheimer DiseaseApproved

Huntington DiseaseApproved

ParagangliomaApproved

Gastrointestinal Stromal TumorApproved

Terminated

Chronic Myelogenous LeukemiaApproved

Completed

Systemic MastocytosisPreclinical

Active, not recruiting

Breast CancerApproved

Approved

Stem Cell TransplantPhase 2

Not yet recruiting

Low Grade GliomaApproved

Approved

Tenosynovial Giant Cell Tumor, Diffuse TypeApproved

Approved

Alzheimer DiseaseApproved

Approved

Huntington DiseaseApproved

Approved

ParagangliomaApproved

Approved

Showing 10 of 27 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tasigna

AAzurity Pharmaceuticals

Adenocard

2 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Lexiscan

Astellas

Preclinical

1 6

Voltaren

Novartis

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Neoplasms

NCT04449549

Phase 2Active, not recruiting

Metastatic Malignant Solid Neoplasm

NCT05554341

Q3 2027

Phase 2Active, not recruiting

Treatment

NCT02917720

Q4 2027

Phase 2Recruiting

Trial

NCT02925234

Phase 2Active, not recruiting

Chronic Myeloid Leukemia

NCT03906292

Q3 2028

Phase 2Active, not recruiting

Myeloid Leukemia

NCT03654768

Clinical

Trials by Indication[1]

Myeloid Leukemia25 trials

Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia

Active, not recruiting·MMasaryk University·Phase 2·NCT04147533·150 enrolled

Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy

Completed· Novartis logo

Novartis·Phase 1·NCT01456676·11 enrolled

Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

Completed· Novartis logo

Novartis·Phase 1·NCT01220648·4 enrolled

Show 22 more trials

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Completed· Novartis logo

Novartis·Phase 2·NCT03578367·104 enrolled

Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial

Completed· Novartis logo

Novartis·Phase 4·NCT01368523·19 enrolled

Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib

Unknown status·SSamsung Medical Center·Phase 4·NCT02389920·40 enrolled

An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02225574·1 enrolled

Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

No longer available· Novartis logo

Novartis··NCT00413270

Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Unknown status·TThe First Affiliated Hospital of Soochow University··NCT04739826·491 enrolled

A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia

Terminated·AAriad Pharmaceuticals·Phase 3·NCT02627677·44 enrolled

A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Completed· Novartis logo

Novartis·Phase 3·NCT01126892·6 enrolled

TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study

Completed·UUniversity of Jena·Phase 3·NCT01657604·717 enrolled

Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology··NCT04681820·200 enrolled

Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Approved for marketing· Novartis logo

Novartis··NCT00905593

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01254188·421 enrolled

Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

Active, not recruiting·SSWOG Cancer Research Network·Phase 2·NCT03654768·81 enrolled

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Recruiting·KKartos Therapeutics, Inc.·Phase 1/2·NCT04835584·109 enrolled

Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01751425·8 enrolled

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia

Unknown status·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 4·NCT02602314·450 enrolled

Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia

Terminated·HHamad Medical Corporation·Phase 3·NCT03079505·10 enrolled

Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

Unknown status·—·Phase 1·NCT03228303·100 enrolled

Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

Terminated·EEmory University·Phase 2·NCT02709083·7 enrolled

Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01702064·11 enrolled

Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

Completed· Pfizer logo

Pfizer··NCT05286528·1,484 enrolled

Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Completed· Novartis logo

Novartis·Phase 4·NCT00786812·89 enrolled

Chronic Myelogenous Leukemia17 trials

Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00769327·129 enrolled

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

Terminated· Novartis logo

Novartis·Phase 2·NCT00644878·18 enrolled

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00129740·148 enrolled

Show 14 more trials

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Completed· Novartis logo

Novartis·Phase 3·NCT00471497·846 enrolled

A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Completed· Novartis logo

Novartis·Phase 3·NCT02272777·225 enrolled

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Completed· Novartis logo

Novartis·Phase 1/2·NCT00109707·507 enrolled

Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia

Completed·—·N/A·NCT01316250·13 enrolled

Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Completed·CCancer Trials Ireland·Phase 2·NCT00809211·40 enrolled

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Completed· Novartis logo

Novartis·Phase 4·NCT00980018·52 enrolled

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Completed· Novartis logo

Novartis·Phase 2·NCT01844765·59 enrolled

Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Completed· Novartis logo

Novartis·Phase 2·NCT01274351·112 enrolled

Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

Completed· Novartis logo

Novartis·Phase 4·NCT01043874·45 enrolled

Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Terminated· Novartis logo

Novartis·Phase 3·NCT00519090·6 enrolled

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05456191·568 enrolled

Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

Completed· Novartis logo

Novartis·Phase 3·NCT00760877·207 enrolled

A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment.

Completed· Novartis logo

Novartis·Phase 2·NCT01784068·215 enrolled

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

Recruiting· Novartis logo

Novartis·Approved·NCT04877522·347 enrolled

Acute Lymphoblastic Leukemia9 trials

Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Terminated·RRony Schaffel·Phase 1/2·NCT00905398·8 enrolled

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·—·Phase 2·NCT00844298·91 enrolled

Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Completed·GGoethe University·Phase 2·NCT01528085·79 enrolled

Show 6 more trials

MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

No longer available· Novartis logo

Novartis··NCT04559555

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00036738·28 enrolled

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Completed· Novartis logo

Novartis·Phase 1·NCT01077544·15 enrolled

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Withdrawn·MMayo Clinic·Phase 2·NCT01670084

Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

Completed· Novartis logo

Novartis·Phase 1/2·NCT01279473·42 enrolled

Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT01025505·40 enrolled

Treatment8 trials

A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

Unknown status·NNational Research Center for Hematology, Russia·Phase 2·NCT04578847·100 enrolled

De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia

Completed·UUniversity of Liverpool·Phase 2·NCT01804985·174 enrolled

A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

Completed· Novartis logo

Novartis·Phase 2·NCT01744665·59 enrolled

Show 5 more trials

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

Completed· Novartis logo

Novartis·Phase 4·NCT01735955·57 enrolled

Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

Completed· Novartis logo

Novartis·Phase 1·NCT02253277·5 enrolled

2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

Active, not recruiting·EEuropean LeukemiaNet·Phase 2·NCT02917720·75 enrolled

Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

Completed· Novartis logo

Novartis·Phase 2·NCT01863745·15 enrolled

PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

Recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT06409936·160 enrolled

Gastrointestinal Stromal Tumor7 trials

Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Completed· Novartis logo

Novartis·Phase 2·NCT01110668·2 enrolled

Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST)

Terminated·FFox Chase Cancer Center·Phase 2·NCT00782834·13 enrolled

Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

Completed· Novartis logo

Novartis·Phase 3·NCT01289028·125 enrolled

Show 4 more trials

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

Terminated· Novartis logo

Novartis·Phase 3·NCT00751036·94 enrolled

Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST)

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT01270893

Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK

Completed·—··NCT00976612·17 enrolled

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Terminated·FFox Chase Cancer Center·Phase 2·NCT01089595·5 enrolled

67 more indications

Newly Diagnosed4 trials

Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells

Completed·NNiguarda Hospital·Phase 2·NCT01856283·87 enrolled

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

Completed· Novartis logo

Novartis·Phase 4·NCT01227577·128 enrolled

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Unknown status·SShenzhen Second People's Hospital·Phase 3·NCT03942094·100 enrolled

Show 1 more trial

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

Completed· Novartis logo

Novartis·Phase 4·NCT01061177·1,090 enrolled

Chronic4 trials

Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib

Terminated· Novartis logo

Novartis·Phase 3·NCT02115386·7 enrolled

Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

Completed·HHospices Civils de Lyon·Phase 3·NCT02201459·200 enrolled

A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT02973711

Show 1 more trial

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

Completed· Novartis logo

Novartis·Phase 4·NCT02546674·171 enrolled

CML3 trials

Nilotinib, for Patients With CML-CP or CML-AP

No longer available· Novartis logo

Novartis··NCT04518644

Nilotinib in PH+, BCR-, ABL+ CML Patients

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 3·NCT01535391·109 enrolled

Tasigna in Glivec-resistant or Intolerant Patients in CML

Completed· Novartis logo

Novartis·Phase 4·NCT01206088·93 enrolled

Acute Myeloid Leukemia3 trials

Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·MMayo Clinic·Phase 2·NCT01806571·34 enrolled

Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia

Terminated·UUniversity Health Network, Toronto·Phase 1/2·NCT01222143·12 enrolled

Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia

Completed·TTechnical University of Munich·Phase 1/2·NCT00762632·40 enrolled

Melanoma3 trials

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

Completed·—·Phase 2·NCT00788775·20 enrolled

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Completed· Novartis logo

Novartis·Phase 2·NCT01028222·55 enrolled

Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01168050·25 enrolled

Tyrosine Kinase Inhibitors3 trials

Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.

Terminated· Novartis logo

Novartis·Phase 3·NCT02108951·20 enrolled

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

Completed·MMedical College of Wisconsin·Phase 2·NCT02269267·173 enrolled

Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients

Completed·UUNC Lineberger Comprehensive Cancer Center··NCT03885830·45 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Nilotinib in CML-CP

Completed·SSeoul National University Hospital·Phase 4·NCT03332511·110 enrolled

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

Completed· Novartis logo

Novartis·Phase 3·NCT00471328·248 enrolled

Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy

Terminated·KKing Abdullah International Medical Research Center·Phase 4·NCT02086487·98 enrolled

Chronic Myeloid Leukemia3 trials

Frontline Asciminib Combination in Chronic Phase CML

Active, not recruiting·UUniversity of Jena·Phase 2·NCT03906292·125 enrolled

A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

Completed· Novartis logo

Novartis·Phase 2·NCT01698905·163 enrolled

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

Terminated· Novartis logo

Novartis·Phase 2·NCT03874858·135 enrolled

Stem Cell Transplant2 trials

Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00702403·40 enrolled

Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML

Not yet recruiting·TThe University of Hong Kong·Phase 2·NCT07493408·45 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01275196·267 enrolled

Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD

Completed·GGruppo Italiano Trapianto di Midollo Osseo·Phase 1·NCT01810718·22 enrolled

Tics2 trials

Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers

Completed·JJan Beumer·Phase 1·NCT00732888·14 enrolled

Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT00418756·12 enrolled

Chemotherapy2 trials

Nilotinib-Chemotherapy in CML Myeloid BP or Bcr-abl(+) AML

Unknown status·UUlsan University Hospital·Phase 2·NCT01690065·46 enrolled

A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02611492·265 enrolled

Randomized2 trials

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Completed· Novartis logo

Novartis·Phase 3·NCT01743989·620 enrolled

Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

Completed· Novartis logo

Novartis·Phase 3·NCT00802841·191 enrolled

Parkinson's Disease2 trials

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease

Unknown status·GGeorgetown University·Phase 2·NCT02954978·75 enrolled

Nilotinib in Parkinson's Disease

Completed·NNorthwestern University·Phase 2·NCT03205488·76 enrolled

Metastatic Melanoma2 trials

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Recruiting·RRina Plattner·Phase 1·NCT04903119·30 enrolled

Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Completed·SSamsung Medical Center·Phase 2·NCT01099514·33 enrolled

Pulmonary Arterial Hypertension1 trial

Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

Terminated· Novartis logo

Novartis·Phase 2·NCT01179737·23 enrolled

Tyrosine Kinase Inhibitor1 trial

Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02733445·2,650 enrolled

Leiomyosarcoma1 trial

Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

Unknown status·—·Phase 1/2·NCT02587169·40 enrolled

Leukaemia1 trial

Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia

Completed·AAustralasian Leukaemia and Lymphoma Group·Phase 2·NCT02001818·60 enrolled

Efficacy1 trial

Efficacy of Nilotinib Versus Imatinib in Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib

Unknown status·SSeoul St. Mary's Hospital·Phase 3·NCT01400074·100 enrolled

Early Alzheimer's Disease1 trial

Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

Not yet recruiting·KKeifeRx, LLC·Phase 3·NCT05143528·1,275 enrolled

Patients With Solid Tumors1 trial

A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors

Terminated·GGeorgetown University·Phase 1·NCT01871311·15 enrolled

Vinblastine1 trial

Study Of Vinblastine in Combination With Nilotinib in Children, Adolescents and Young Adults

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT01884922·35 enrolled

Metastatic Colon Cancer1 trial

Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer

Withdrawn·IInstitut Bergonié·Phase 1·NCT02774512

Prospective1 trial

Prospective Investigation of Dynamics of ABL Mutations in Imatinib Failed CML Patients Treated With Nilotinib

Unknown status·SSeoul St. Mary's Hospital··NCT01562847·125 enrolled

Concentration1 trial

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

Terminated· Novartis logo

Novartis·Phase 4·NCT01131325·3 enrolled

Giant Cell Tumor1 trial

Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

Completed·—·Phase 2·NCT01207492·17 enrolled

Vestibular schwannoma1 trial

A Study of Nilotinib in Growing Vestibular Schwannomas

Terminated·UUniversity Health Network, Toronto·Phase 2·NCT01201538·2 enrolled

ESS1 trial

MAP to Provide Access to Nilotinib, for Patients With HES

No longer available· Novartis logo

Novartis··NCT04498871

Refractory1 trial

A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL

Completed· Novartis logo

Novartis·Phase 1/2·NCT00384228·42 enrolled

Complete Response1 trial

Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

Completed· Novartis logo

Novartis·Phase 1·NCT00441155·14 enrolled

Peripheral Neuropathy1 trial

Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer

Completed·OOhio State University Comprehensive Cancer Center·Phase 1·NCT04205903·11 enrolled

Huntington's Disease1 trial

Nilotinib in Huntington's Disease

Unknown status·GGeorgetown University·Phase 1·NCT03764215·10 enrolled

Leukemia1 trial

Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT01914484·4 enrolled

Parkinson disease1 trial

Nilotinib in Cognitively Impaired Parkinson Disease Patients 001

Completed·GGeorgetown University·Phase 1·NCT02281474·12 enrolled

Pilot Study1 trial

Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

Completed·UUniversity Hospital, Bordeaux·Phase 2·NCT01774630·31 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Chronic Graft Versus Host Disease1 trial

Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

Completed·SStanford University·Phase 1·NCT01155817·33 enrolled

Cerebellar Ataxia1 trial

Effect of Nilotinib in Cerebellar Ataxia Patients

Completed·SSeoul National University Hospital·Phase 2·NCT03932669·70 enrolled

Mucosal Melanoma1 trial

A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread

Completed·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT01395121·29 enrolled

Malignant Glioma1 trial

Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas

Completed·—·Phase 2·NCT01140568·38 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

Completed·NNational Taiwan University Hospital·Phase 2·NCT01252017·36 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

TED1 trial

Nilotinib Plus Pegylated Interferon-α2b in CML

Terminated·AAmsterdam UMC, location VUmc·Phase 2·NCT01866553·20 enrolled

First-line Treatment1 trial

Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00481052·74 enrolled

Chordoma1 trial

Nilotinib With Radiation for High Risk Chordoma

Completed·MMassachusetts General Hospital·Phase 1·NCT01407198·23 enrolled

Hepatic Function1 trial

Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Completed· Novartis logo

Novartis·Phase 1·NCT00418626·27 enrolled

MPA1 trial

Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Completed· Novartis logo

Novartis·Phase 1·NCT00418769·24 enrolled

Stem Cell1 trial

Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy

Completed·WWeill Medical College of Cornell University·Phase 2·NCT02353728·16 enrolled

Dementia1 trial

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies

Recruiting·GGeorgetown University·Phase 2·NCT04002674·60 enrolled

GIST1 trial

A Study of Nilotinib Versus Imatinib in GIST Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00785785·644 enrolled

Systemic Sclerosis1 trial

Nilotinib in the Treatment of Systemic Sclerosis

Completed·HHospital for Special Surgery, New York·Phase 2·NCT01166139·10 enrolled

Ph+ ALL1 trial

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

Completed· Novartis logo

Novartis·Phase 1·NCT02081378·326 enrolled

Quality of Life1 trial

Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response

Completed·AAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·Phase 3·NCT02326311·229 enrolled

Allogeneic Stem Cell Transplantation1 trial

Nilotinib Pre and Post Allogeneic Stem Cell Transplantation

Completed·SSheba Medical Center·Phase 2·NCT00750659·24 enrolled

Advanced Malignant Solid Neoplasm1 trial

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

Solid Tumor1 trial

Phase I Trial of the Combination of Nilotinib and Paclitaxel in Adults and Pediatric Patients With Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02379416·47 enrolled

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

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

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT03516279·40 enrolled

Neoplasms1 trial

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04449549·82 enrolled

Chronic Myeloid Leukemia (CML)1 trial

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

Active, not recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 3·NCT04971226·405 enrolled

Chronic Phase Chronic Myelogenous Leukemia1 trial

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

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04838041·51 enrolled

Metastatic Malignant Solid Neoplasm1 trial

Nilotinib and Paclitaxel in Patients With Prior Taxane-Treated Solid Tumors: A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554341·40 enrolled

Malignant Solid Neoplasms1 trial

A Two-period, Multicenter, Randomized, Open-label, Phase II Study Evaluating the Clinical Benefit of a Maintenance Treatment Targeting Tumor Molecular Alterations in Patients With Progressive Locally-advanced or Metastatic Solid Tumors

Recruiting·CCentre Leon Berard·Phase 2·NCT02029001·900 enrolled

Alzheimer's Disease1 trial

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib (Tasigna®) on Safety, Biomarkers and Clinical Outcomes in Subjects With Mild to Moderate Alzheimer's Disease

Completed·GGeorgetown University·Phase 2·NCT02947893·37 enrolled

Gastrointestinal Stromal Tumors1 trial

An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

Completed· Novartis logo

Novartis·Approved·NCT00756509·34 enrolled

Gynecologic Cancer1 trial

Phase II Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT05185947·21 enrolled

Unspecified1 trial

An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Terminated·PProf. Dr. Nikolas von Bubnoff·Phase 3·NCT02174445·14 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 22, 2018

TASIGNA

NDA NDA022068

Nov 7, 2024

DANZITEN

NDA NDA219293

May 29, 2026

CAVHANZA

NDA NDA217379

Sources

References

[1]
ClinicalTrials.gov — 158 trial records for Nilotinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tasigna drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nilotinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nilotinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217379). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tasigna. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase ABL Inhibitor; Bcr/abl Fusion Protein Inhibitor[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Jan 18, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8501760Jul 18, 2026

8389537Jul 18, 2026

8415363Jul 18, 2026

8389537*PEDJan 18, 2027

8501760*PEDJan 18, 2027

15 more patents

8415363*PEDJan 18, 2027

8293756Sep 25, 2027

8293756*PEDMar 25, 2028

8163904Aug 23, 2028

8163904*PEDFeb 23, 2029

9061029Apr 7, 2032

9061029*PEDOct 7, 2032

10874671Feb 18, 2040

11793809Feb 18, 2040

12629369Feb 18, 2040

12403140Feb 18, 2040

12016861Jan 28, 2041

11389450Jan 28, 2041

12029740Jan 28, 2041

11559485Apr 29, 2041