Recent Updates
Recently added Catalysts

627

Phase 2

Ulcerative Colitis (UC) | Small molecule | Gastrointestinal |Sunshine Biopharma Inc.|Last Updated: Jul 28, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment288

FDA Designations

No designations recorded

Clinical trial landscape

627 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07507513The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UCUlcerative Colitis (UC)
RECRUITING288 Analytics
PHASE2RECRUITING
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
Ulcerative Colitis (UC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events
During the 36-week study period

Secondary Endpoints

Clinical remission based on Mayo Score (MMS)
Week 14
Clinical response based on Mayo Score (MMS)
Week 14
Endoscopic improvement
Week 14
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group M1EXPERIMENTALdose level 1 of 627
Group M2EXPERIMENTALdose level 2 of 627
Group M3EXPERIMENTALdose level 3 of 627
Group M4EXPERIMENTALdose level 4 of 627
Group AEXPERIMENTAL627 Dose A subcutaneous (SC) injection.
Group BEXPERIMENTAL627 Dose B subcutaneous (SC) injection.
PlaceboPLACEBO_COMPARATORPlacebo subcutaneous (SC) injection.
Group CEXPERIMENTAL627 subcutaneous (SC) injection.
627EXPERIMENTAL -

Interventions

NameTypeDescription
627DRUG627 subcutaneous (SC) injection.
PlaceboDRUGPlacebo subcutaneous (SC) injection.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF). 2. Male or female subjects aged 18-75 years old when signing the ICF. 3. Subjects must have been diagnosed with UC for at least 3 months prior to rando...

Countries:China
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWJul 28, 2026NCT07507513Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 28, 2026NCT07507513Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed
LOWJul 5, 2026NCT07065136primaryCompletionDate: changed
LOWJul 5, 2026NCT07507513primaryCompletionDate: changed

Frequently asked questions about 627

What is 627 used for?

627 is an investigational monoclonal antibody being developed for the treatment of ulcerative colitis (UC). It is also being evaluated in healthy subjects to assess its safety and tolerability. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does 627 target?

627 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat ulcerative colitis, an inflammatory bowel disease, though the exact mechanism of action is not publicly detailed.

Who makes 627?

627 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy subjects and patients with ulcerative colitis.

What phase is 627 in?

627 is in Phase 1 clinical development for healthy subjects and Phase 2 clinical development for ulcerative colitis. The Phase 1 trial is not yet recruiting, while the Phase 2 trial is currently recruiting participants in China. The drug remains investigational and is not yet approved.

What clinical trials is 627 in?

627 is being studied in two clinical trials. NCT07065136 is a Phase 1 trial in healthy adult subjects with an enrollment of 108. NCT07507513 is a Phase 2 trial in patients with ulcerative colitis, enrolling 288 participants in China. Both trials are randomized, double-blind, and placebo-controlled.

Is 627 the same as any other drug?

No alternative names for 627 have been disclosed. The drug is identified solely by its code name 627 in clinical trial registrations and company communications. It is a distinct investigational monoclonal antibody being developed by Sunshine Biopharma Inc.