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Privosegtor

Phase 3

Optic Neuritis | Small molecule | Neurology |Oculis Holding AG|Trials Updated: Aug 14, 2026

Privosegtor development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2026

Privosegtor target and mechanism

Molecular targetSGK2
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment210

FDA Designations

BREAKTHROUGH_THERAPYORPHAN_DRUGPRIORITY_REVIEW

Privosegtor clinical trials

Privosegtor · 1 trial · 1 indication

Phase 3 1
NCT07623668Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation ResearchOptic Neuritis
RECRUITING210 Analytics
PHASE3RECRUITING
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
Optic NeuritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
3 months

Secondary Endpoints

Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).
3 months
Mean change from baseline in low contrast visual acuity (LCVA).
3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PrivosegtorEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PrivosegtorDRUGPrivosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
MethylprednisoloneDRUGMethylprednisolone 1 g/day IV for 5 treatment days
PlaceboOTHER0.9% sodium chloride (NaCl) solution IV for 5 treatment days
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss. * Onset of visual loss symptoms in the previous 12 days before first administration of study treatment. Key Exclusion Criteria: \- Have a hist...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 30, 2026NCT07623668lastUpdatePostDate: changed
LOWOct 30, 2026NCT07623668lastUpdatePostDate: changed
LOWOct 30, 2026NCT07623668lastUpdatePostDate: changed

Frequently asked questions about Privosegtor

What is Privosegtor?

Privosegtor is an investigational small molecule developed by Oculis Holding AG for the treatment of optic neuritis, an inflammatory condition affecting the optic nerve. It is currently in Phase 3 clinical development and has received Breakthrough Therapy, Orphan Drug, and Priority Review designations from the FDA.

What is Privosegtor used for in optic neuritis?

Privosegtor is being developed for optic neuritis, a neurological condition involving inflammation of the optic nerve. It is an investigational therapy in Phase 3 testing and is not yet approved for commercial use. The FDA has granted it Breakthrough Therapy, Orphan Drug, and Priority Review designations for this indication.

What does Privosegtor target?

Privosegtor targets SGK2, also known as serum and glucocorticoid-regulated kinase 2. It is a small molecule designed to modulate this target as a potential treatment for optic neuritis. Targeting SGK2 represents a specific molecular approach in the neurology therapeutic area.

Who is developing Privosegtor?

Privosegtor is being developed by Oculis Holding AG, a biopharmaceutical company traded under the ticker OCS. Oculis is advancing the drug through Phase 3 clinical development for optic neuritis, with the FDA having granted Breakthrough Therapy, Orphan Drug, and Priority Review designations.

What phase is Privosegtor in?

Privosegtor is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is currently recruiting participants, and the program has received Breakthrough Therapy, Orphan Drug, and Priority Review designations from the FDA.

What clinical trials is Privosegtor in?

Privosegtor is being evaluated in a Phase 3 clinical trial, NCT07623668, titled Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research. The trial is recruiting, with an estimated enrollment of 210 participants, and is a randomized, double-blind, placebo-controlled study conducted in the United States.