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CML

7
Pipeline Programs
4
Companies
7
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
3
0
0
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 3 programs with unclassified modality

On Market (1)

Approved therapies currently available

Novartis
TASIGNAApproved
nilotinib
Novartis
oral2007
395M Part D

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
5 programs
3
2
nilotinibPhase 4Small Molecule1 trial
nilotinibPhase 4Small Molecule1 trial
Asciminib add-onPhase 21 trial
high-dose imatinibPhase 2Small Molecule1 trial
nilotinibPhase 2Small Molecule1 trial
Active Trials
NCT03578367Completed104Est. Feb 2025
NCT01216085Completed10Est. Jul 2011
NCT01744665Completed59Est. Sep 2018
+2 more trials
Novartis
NovartisBASEL, Switzerland
1 program
1
nilotinibPHASE_4Small Molecule
Pfizer
PfizerNEW YORK, NY
1 program
1
200 Mg capsules of bosutinib in Water solutionPhase 11 trial
Active Trials
NCT03747679Completed8Est. Jan 2019
Inhibikase Therapeutics
1 program
Imatinib MesylatePHASE_11 trial
Active Trials
NCT05623774Completed64Est. Dec 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Sandoznilotinib
Sandoznilotinib
SandozAsciminib add-on
Sandoznilotinib
Sandozhigh-dose imatinib
Inhibikase TherapeuticsImatinib Mesylate
Pfizer200 Mg capsules of bosutinib in Water solution

Clinical Trials (7)

Total enrollment: 341 patients across 7 trials

NCT01131325Sandoznilotinib

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

Start: Oct 2010Est. completion: May 20113 patients
Phase 4Terminated
NCT01206088Sandoznilotinib

Tasigna in Glivec-resistant or Intolerant Patients in CML

Start: Feb 2009Est. completion: Sep 201293 patients
Phase 4Completed
NCT03578367SandozAsciminib add-on

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.

Start: Nov 2018Est. completion: Feb 2025104 patients
Phase 2Completed
NCT01744665Sandoznilotinib

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

Start: Aug 2013Est. completion: Sep 201859 patients
Phase 2Completed
NCT01216085Sandozhigh-dose imatinib

An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints

Start: Aug 2010Est. completion: Jul 201110 patients
Phase 2Completed
NCT05623774Inhibikase TherapeuticsImatinib Mesylate

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg

Start: Dec 2022Est. completion: Dec 202464 patients
Phase 1Completed
NCT03747679Pfizer200 Mg capsules of bosutinib in Water solution

Palatability (Taste) of Oral Formulations of Bosutinib

Start: Nov 2018Est. completion: Jan 20198 patients
Phase 1Completed

Related Jobs

Director Medical Communications

NovartisNovartis
Remote
4w ago
$186K - $345K/yr

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

Small Molecule is the dominant modality (100% of programs)
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.