Recent Updates
Recently added Catalysts

DNK333 twice daily

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Novartis AG|Last Updated: Feb 1, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

DNK333 twice daily · 1 trial · 1 indication

Phase 1 1
NCT01287325Efficacy of DNK333 in Patients With COPD and CoughChronic Obstructive Pulmonary Disease
COMPLETED28 Analytics
PHASE1COMPLETED
Efficacy of DNK333 in Patients With COPD and Cough
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Self-reported cough
At 2 weeks

Secondary Endpoints

Sensitivity to capsaicin challenge
At 2 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DNK333EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DNK333 100 mg twice dailyDRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range35 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Mild to moderate COPD * Forced expiratory volume in 1 second (FEV1) ≥30% predicted * FEV1/FVC (forced vital capacity) \<70% * Significant amount of cough and minimal amount of sputum production, both as judged by self reporting Exclusion criteria: * Upper or lower airway inf...

Countries:NetherlandsUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about DNK333 twice daily

What is DNK333 used for in Chronic Obstructive Pulmonary Disease?

DNK333 is an investigational small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered twice daily and is currently in Phase 1 clinical development. The drug is being evaluated for its efficacy in patients with COPD and cough.

Who makes DNK333?

DNK333 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development for the treatment of Chronic Obstructive Pulmonary Disease.

What phase is DNK333 in?

DNK333 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease, with one completed Phase 1 clinical trial.

What clinical trials is DNK333 in?

DNK333 has one completed clinical trial registered under NCT01287325, titled "Efficacy of DNK333 in Patients With COPD and Cough." This Phase 1 study enrolled 28 participants with Chronic Obstructive Pulmonary Disease and was conducted in the Netherlands and the United Kingdom.

Is DNK333 a randomized controlled trial drug?

Yes, the clinical trial for DNK333 was a randomized, double-blind, placebo-controlled study. This design helps evaluate the drug's efficacy and safety compared to a placebo in patients with Chronic Obstructive Pulmonary Disease and cough.

What is the development status of DNK333?

DNK333 is an investigational small molecule in Phase 1 clinical development for Chronic Obstructive Pulmonary Disease. It has completed one clinical trial with 28 participants, and the drug remains under investigation. It is not yet approved for any use.