Recent Updates
Recently added Catalysts

610

Phase 3

Asthma | Small molecule | Respiratory |Sunshine Biopharma Inc.|Last Updated: Jan 29, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment705

FDA Designations

No designations recorded

Clinical trial landscape

610 · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT06323213Efficacy and Safety Study of 610 in Patients With Severe AsthmaAsthma
RECRUITING480 Analytics
PHASE3RECRUITING
Efficacy and Safety Study of 610 in Patients With Severe Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized rate of severe exacerbation events
Up to 52 weeks

Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period

Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
Baseline (Day 1) and at week 52

FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

Secondary Endpoints

Time to first severe exacerbation event
Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
Up to 52 weeks
Change from baseline in ACQ score
Up to 52 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
610 groupEXPERIMENTALSubjects will receive 610 for 52 weeks.
placebo groupPLACEBO_COMPARATORSubjects will receive placebo for 52 weeks.
Group AEXPERIMENTALSubjects will receive 610 for 52 weeks.
Group BEXPERIMENTALSubjects will receive 610 for 52 weeks.

Interventions

NameTypeDescription
610DRUG610 subcutaneously injection.
PlaceboDRUGPlacebo subcutaneously injection.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able to give written informed consent prior to participation in the study. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. Documented diagnosis of asthma for at least one year prior to screening. 4. History of physician-diagnosed asthma ...

Countries:China
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed
LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed
LOWJul 5, 2026NCT06323213primaryCompletionDate: changed
LOWJul 5, 2026NCT06680947primaryCompletionDate: changed

Frequently asked questions about 610

What is 610 used for?

610 is an investigational small molecule being developed for the treatment of asthma, specifically severe asthma and severe eosinophilic asthma. It is currently in clinical development and has not been approved by regulatory authorities.

Who makes 610?

610 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials for 610 in patients with asthma.

What phase is 610 in?

610 is in Phase 3 clinical development for severe asthma. A Phase 2b study in severe eosinophilic asthma is also active. The drug is investigational and has not received regulatory approval.

What clinical trials is 610 in?

610 is being studied in two clinical trials: NCT06323213, a Phase 3 study in patients with severe asthma, and NCT06680947, a Phase 2b study in participants with severe eosinophilic asthma. Both trials are randomized, double-blind, and placebo-controlled.

Is 610 the same as any other drug?

610 is the code name for the investigational drug developed by Sunshine Biopharma Inc. No alternative names for 610 have been disclosed in the clinical trial information.