This section highlights FDA-related milestones and regulatory updates for drugs developed by Ovid Therapeutics (OVID).
Over the past two years, Ovid Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OV329 and OV350. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
OV329 FDA Regulatory Timeline and Events
OV329 is a drug developed by Ovid Therapeutics for the following indication: In Treatment-Resistant Seizures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OV329
- Announced Date:
- March 18, 2026
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. reported favorable topline safety, tolerability and pharmacokinetics (PK) findings from the 7 mg dose cohort of OV329, its next generation GABA-aminotransferase (GABA-AT) inhibitor.
AI Summary
Ovid Therapeutics reported favorable topline safety, tolerability and pharmacokinetics (PK) from the 7 mg dose cohort of OV329, their next-generation GABA-AT inhibitor for drug-resistant epilepsies. The 7 mg data build on earlier cortical inhibition and tolerability seen at 3 mg and 5 mg, and helped inform dose selection for planned patient studies. Overall, OV329 at 7 mg showed a safety and PK profile supportive of moving into clinical testing in patients.
The company plans a Phase 2 dose-confirmatory and open-label proof-of-concept study and is expanding OV329 development into tuberous sclerosis complex (TSC) seizures and infantile spasms (IS). Ovid is creating a pediatric-friendly formulation for infants and children and expects a TSC safety and signal-finding study in Q4 2026 and an IS study in 2027. These programs will run alongside the focal-onset seizures program to potentially accelerate development.
Read Announcement- Drug:
- OV329
- Announced Date:
- October 3, 2025
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) activity of OV329, a next generation GABA-aminotransferase (GABA-AT) inhibitor being developed for drug-resistant epilepsies.
AI Summary
Ovid Therapeutics announced positive topline results from its Phase 1 study of OV329, a next-generation GABA-aminotransferase inhibitor for drug-resistant epilepsies. The trial in 68 healthy volunteers assessed safety, tolerability, pharmacokinetics and pharmacodynamics across single and multiple ascending dose cohorts.
An expansive biomarker study using transcranial magnetic stimulation showed OV329 delivered significant GABA-AT inhibition that matched or exceeded therapeutic doses of vigabatrin. Magnetic resonance spectroscopy and EEG confirmed brain penetration and elevated GABA levels at a 5 mg dose over seven days.
OV329 was well tolerated, with only mild, transient side effects reported and no evidence of retinal or ocular changes. Ophthalmic exams remained normal through Day 30, supporting a cleaner safety profile than marketed anti-seizure medicines.
Based on these results, Ovid plans to advance OV329 into a Phase 2a study in drug-resistant focal onset seizures in mid-2026.
Read Announcement- Drug:
- OV329
- Announced Date:
- October 3, 2025
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) activity of OV329, a next generation GABA-aminotransferase (GABA-AT) inhibitor being developed for drug-resistant epilepsies.
AI Summary
Ovid Therapeutics announced positive topline results from its Phase 1 study of OV329, a next-generation GABA-aminotransferase (GABA-AT) inhibitor for drug-resistant epilepsy. In 68 healthy volunteers, OV329 was given at 1–5 mg daily over 7 days and assessed for safety, tolerability, pharmacokinetics and pharmacodynamics. A comprehensive biomarker program using transcranial magnetic stimulation showed OV329 produced highly significant, dose-dependent inhibition of GABA-AT—matching or exceeding the inhibition seen with therapeutic doses of vigabatrin. Measures such as long-interval intracortical inhibition and the cortical silent period confirmed brain penetration, target engagement and increased GABA levels.
OV329 was well tolerated, with only mild, transient adverse events and no observed eye or retinal changes. These results support advancing OV329 into a Phase 2a study in patients with drug-resistant focal onset seizures, planned to begin in Q2 2026.
Read Announcement- Drug:
- OV329
- Announced Date:
- September 26, 2024
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. announced that it presented the results of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with vigabatrin (VGB) the only FDA-approved GABA-aminotransferase (GABA-AT) inhibitor.
AI Summary
Ovid Therapeutics recently presented results from a head-to-head animal study comparing its compound OV329 with vigabatrin (VGB), the only FDA-approved GABA-aminotransferase inhibitor. In this study, mice received continuous infusion via a subcutaneous osmotic pump for 48 hours. Unlike VGB, which has been shown to preferentially accumulate in the retina, eyes, and brain, OV329 was rapidly cleared from these tissues and remained undetectable. This lack of accumulation is believed to be due to OV329’s short half-life and fast tissue elimination, while still providing a prolonged pharmacodynamic effect.
These promising findings suggest that OV329 may offer a safer ocular profile compared to VGB, with effective seizure control potential. Ovid Therapeutics plans to move forward with a Phase 1 clinical trial in healthy volunteers, expected to complete in late 2024, to further assess the safety and clinical effects of OV329.
Read Announcement- Drug:
- OV329
- Announced Date:
- September 26, 2024
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. announced that it presented the results of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with vigabatrin (VGB) the only FDA-approved GABA-aminotransferase (GABA-AT) inhibitor.
AI Summary
Ovid Therapeutics Inc. presented findings from a head-to-head animal study that compared OV329 with vigabatrin, the only FDA-approved GABA-aminotransferase inhibitor. The study showed that OV329 did not accumulate in the retinas, eyes, or brains of mice after 48 hours of continuous exposure, while vigabatrin did accumulate in these tissues. Researchers believe that OV329’s short half-life of 1.5 hours and rapid tissue clearance, combined with its prolonged pharmacodynamic effect, may help reduce the risk of ocular side effects seen with vigabatrin. These findings build on previous research showing that OV329, when used at therapeutic doses, does not cause the retinal damage observed with vigabatrin in animal models. Ovid plans to further evaluate OV329’s safety and efficacy in a Phase 1 trial in healthy volunteers, scheduled for completion in late 2024.
Read Announcement
OV350 FDA Regulatory Events
OV350 is a drug developed by Ovid Therapeutics for the following indication: Direct Activator of Potassium-Chloride Cotransporter 2 (KCC2).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OV350
- Announced Date:
- December 18, 2025
- Indication:
- Direct Activator of Potassium-Chloride Cotransporter 2 (KCC2)
Announcement
Ovid Therapeutics Inc. announced results from its Phase 1 study of OV350, the first-ever KCC2 direct activator known to be dosed in humans.
AI Summary
Ovid Therapeutics reported Phase 1 results for OV350, the first KCC2 direct activator dosed in humans. In a randomized, placebo-controlled single-ascending dose IV study (16 healthy volunteers, 50 mg and 100 mg given over 10 minutes), the trial met its primary goals of safety, tolerability and pharmacokinetics. OV350 showed a favorable safety profile: the most common treatment-emergent adverse event was headache; some participants had nausea and vomiting that coincided with meals and are thought to be off-target effects of OV350. There were no treatment-related laboratory abnormalities, no treatment-related serious adverse events, and stopping criteria were not met. Pharmacokinetics matched predictions and exposure reached levels expected to be pharmacologically active.
Exploratory qEEG measures suggested central nervous system activity and spectral changes consistent with KCC2 modulation, aligning with expected brain exposure. These results support advancing Ovid’s KCC2 program toward oral direct activators, will inform dosing strategies in future studies, and underpin plans to move the oral candidate OV4071 forward toward a Phase 1/1b regulatory submission in Q1 2026.
Read Announcement
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