Recent Updates
Recently added Catalysts

Nuvastatic

Phase 1

Diabetic Retinopathy | Small molecule | Ophthalmology |Quest Diagnostics Inc.|Last Updated: Dec 12, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04552600Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.PHASE1 COMPLETED 100 — — Sep 1, 2019Aug 10, 2022Dec 12, 20251 India
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate efficacy of Nuvastatic - Retinal Thickness
12 months

Central Subfield Retinal Thickness

To evaluate efficacy of Nuvastatic - protein biomarkers
12 months

protein biomarkers

To evaluate safety of Nuvastatic - Letter Score
12 months

Visual Acuity Letter Score

Secondary Endpoints
To evaluate short-term visual outcomes on severity
12 months
To evaluate short-term visual outcomes on zone diagnosis
12 months
To evaluate short-term visual outcomes on DRSS
12 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NuvastaticTM 1000 mgEXPERIMENTALNuvastaticTM 1000 mg(standardized extract of Orthosiphon Stamineus) will be given orally, three times per day for 12 months.
PlaceboACTIVE_COMPARATORNuvastaticTM (without active) will be given orally, three times per day for 12 months
Interventions
NameTypeDescription
NuvastaticDRUGPhase 1b Interventional, multi-centered, double-masked, randomized
PlaceboOTHERPhase 1b Interventional, multi-centered, double-masked, randomized
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * • Type-2 Diabetes mellius (NIDDM) patients of both genders aged 18-65 years. * Able and willing to provide written informed consent. * Documented diagnosis of Type 2 diabetes mellitus a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at screening. * Patients preferably o...

Countries:India
Unlock Eligibility Criteria
Competitive Landscape -Diabetic Retinopathy 7 trials
CompanyTickerTrialsLead PhaseDrugs
Ocular Therapeutix IncOCUL1PHASE3Single intravitreal of axitinib hydrogel followed by a mock procedure at Week 24, Intravitreal of axitinib hydrogel followed by a second intravitreal of the axitinib at Week 24
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept, Surabgene Lomparvovec, Sham
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
Rhythm Pharmaceuticals, Inc.RYTM1 — Undisclosed
Adverum Biotechnologies, Inc.ADVM1 — ADVM-022
Unlock Competitive Intelligence