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Nuvastatic

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Nuvastatic · 1 trial · 1 indication

Phase 1 1
NCT04552600Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.Diabetic Retinopathy
COMPLETED100 Analytics
PHASE1COMPLETED
Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.
Diabetic RetinopathyUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Nuvastatic

What is Nuvastatic used for in diabetic retinopathy?

Nuvastatic is an investigational small molecule being developed for diabetic retinopathy, a complication of diabetes that damages blood vessels in the retina. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. One clinical trial has been completed to evaluate its efficacy and safety in this condition.

Who makes Nuvastatic?

Nuvastatic is being developed by Quest Diagnostics Inc., a company publicly traded under the ticker symbol DGX. The drug is an investigational small molecule intended for the treatment of diabetic retinopathy. It is currently in Phase 1 clinical development, with one completed trial.

What phase is Nuvastatic in?

Nuvastatic is in Phase 1 clinical development. It is an investigational small molecule for diabetic retinopathy and has not yet been approved by regulatory authorities. One Phase 1 trial has been completed, involving 100 participants, and the drug remains under investigation.

What clinical trials is Nuvastatic in?

Nuvastatic has been studied in one clinical trial, identified as NCT04552600, titled "Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy." This Phase 1 trial was completed in India, enrolled 100 participants aged 18 years and older, and used an active-controlled design.

Is Nuvastatic the same as C5OSEW5050ESA?

Yes, Nuvastatic is also known as C5OSEW5050ESA. The clinical trial NCT04552600, which evaluated the drug in diabetic retinopathy, refers to it as "Nuvastatic™ - C5OSEW5050ESA," confirming that these names refer to the same investigational small molecule.