Recent Updates
Recently added Catalysts

601

Phase 3

Branch Retinal Vein Occlusion | Small molecule | Ophthalmology |Sunshine Biopharma Inc.|Trials Updated: Dec 18, 2025

601 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment471

FDA Designations

No designations recorded

601 clinical trials

601 · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT05520177A Phase III Study for 601 Versus Ranibizumab in Patients With Vision LossBranch Retinal Vein Occlusion
COMPLETED351 Analytics
PHASE3COMPLETED
A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss
Branch Retinal Vein OcclusionUnlock trial analytics

Study Endpoints

Primary Endpoints

best-corrected visual acuity (BCVA)
From Baseline to Week 24

Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts.

Change from baseline in best-corrected visual acuity (BCVA) at Week 24
Baseline to Week 24

Assessed with ETDRS visual acuity testing charts.

Secondary Endpoints

best-corrected visual acuity (BCVA)
up to 52 weeks
central retinal thickness (CRT)
up to 52 weeks
Number of injections
up to 52 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
601 1.25mgEXPERIMENTALloading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
ranibizumab 0.5mgACTIVE_COMPARATORloading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
Ranibizuman 0.5 mgEXPERIMENTAL -

Interventions

NameTypeDescription
601 1.25mgDRUGloading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
ranibizumab 0.5mgDRUGloading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
Ranibizuman 0.5 mgDRUGSolution for injection (intravitreal use)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Sign informed consent form and willing to be followed up at the time specified in the trial * Male or Female, at least 18 years of age * The study eye must meet the following criteria:Diagnosed with macular edema secondary to Branch retinal vein occlusion (BRVO) or Hemi-retina...

Countries:China
Unlock Eligibility Criteria

Frequently asked questions about 601

What is 601 used for?

601 is an investigational small molecule being developed for the treatment of central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), which are eye conditions that can cause vision loss. It is administered as an ophthalmic treatment and is currently in clinical development.

Who makes 601?

601 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 for this drug in patients with retinal vein occlusion.

What phase is 601 in?

601 is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, with the most advanced study being a Phase 3 trial comparing 601 to ranibizumab in patients with vision loss due to branch retinal vein occlusion.

What does 601 target?

601 is a small molecule designed to treat retinal vein occlusion, a condition where a vein in the retina becomes blocked, leading to vision problems. Its specific molecular target has not been disclosed, but it is being studied as a treatment for this eye condition.

What clinical trials is 601 in?

601 has been studied in two completed Phase 2 trials (NCT04667897 and NCT04667910) and one completed Phase 3 trial (NCT05520177). These trials compared 601 to ranibizumab in patients with branch retinal vein occlusion and central retinal vein occlusion.

Is 601 FDA approved?

601 is not FDA approved. It is an investigational drug currently in clinical development, with completed Phase 2 and Phase 3 trials. It has not yet received regulatory approval for marketing in the United States or other countries.