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, OV350, and OV888/GV101. 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- Drug:
- OV329
- Announced Date:
- July 10, 2024
- Indication:
- In Treatment-Resistant Seizures
Announcement
Ovid Therapeutics Inc. announced that eNeuro, a peer-reviewed, open-access journal from the Society for Neuroscience published several preclinical studies validating OV329's mechanism of action and anti-convulsant properties.
AI Summary
Ovid Therapeutics Inc. recently announced that several preclinical studies validating OV329’s mechanism of action and anti-convulsant properties have been published in eNeuro, a peer-reviewed, open-access journal from the Society for Neuroscience. These studies, carried out in collaboration with researchers at Tufts University School of Medicine and University College London, demonstrated that sustained low doses of OV329 reduced GABA-aminotransferase activity and increased GABA levels in the brain. This led to both synaptic and extrasynaptic inhibition, which helped reduce the severity of seizures in preclinical models and prevented the development of resistance to benzodiazepines. The results suggest that OV329, a next-generation GABA-AT inhibitor, might offer a more potent and safer option compared to existing treatments for drug-resistant seizures.
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
OV888/GV101 FDA Regulatory Events
OV888/GV101 is a drug developed by Ovid Therapeutics for the following indication: For Cerebral Cavernous Malformations.
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:
- OV888/GV101
- Announced Date:
- July 1, 2024
- Target Action Date:
- LATE 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- For Cerebral Cavernous Malformations
Announcement
Ovid and Graviton plan to progress to a Phase 2 clinical study in cerebral cavernous malformations (CCM) later this year.
AI Summary
Ovid Therapeutics and Graviton Bioscience announced that their Phase 1 study of the oral ROCK2 inhibitor OV888/GV101 capsule met its main goals. The study, conducted with healthy volunteers, showed a favorable safety and tolerability profile and achieved the target pharmacokinetic levels needed for once-daily dosing. The capsule was biologically active and reduced inflammation markers in a dose-dependent manner.
With these promising results, the companies plan to transition into a Phase 2 clinical study later this year focused on cerebral cavernous malformations (CCM). This upcoming trial aims to test whether OV888/GV101 can become the first oral treatment option for CCM, addressing a significant unmet need in patients who currently have few non-surgical choices. The move to Phase 2 highlights the commitment of both firms to develop innovative therapies for rare neurovascular conditions.
Read Announcement- Drug:
- OV888/GV101
- Announced Date:
- July 1, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- For Cerebral Cavernous Malformations
Announcement
Ovid Therapeutics Inc. announced that A Phase 2 study for the treatment of cerebral cavernous malformations is expected to initiate in the second half of 2024
AI Summary
Ovid Therapeutics Inc. announced that a Phase 2 study for treating cerebral cavernous malformations (CCMs) is expected to start in the second half of 2024. The upcoming study comes after promising Phase 1 results, which demonstrated a favorable safety and tolerability profile for the OV888/GV101 capsule. These early findings showed that the drug achieved its targeted pharmacokinetic exposure, suggesting that once-daily dosing is feasible.
The Phase 2 study will specifically evaluate the drug's potential to benefit patients suffering from CCM, a condition with limited treatment options that currently relies on monitoring or high-risk brain surgery. Ovid’s move into Phase 2 marks a significant step toward offering the first oral therapy for CCM and could pave the way for addressing a critical unmet need in neurovascular treatment.
Read Announcement- Drug:
- OV888/GV101
- Announced Date:
- July 1, 2024
- Indication:
- For Cerebral Cavernous Malformations
Announcement
Ovid Therapeutics Inc. announced the results from their Phase 1 healthy volunteer study evaluating the safety, tolerability, and pharmacokinetic (PK) profile of multiple ascending doses of OV888/GV101 capsule.
AI Summary
Ovid Therapeutics Inc. announced positive results from its Phase 1 study of the OV888/GV101 capsule in healthy volunteers. The study evaluated the safety, tolerability, and pharmacokinetic profile of multiple ascending doses given once daily for seven days. The capsule was well tolerated at all tested doses with no serious adverse events, and most reported side effects, such as mild headaches, were temporary. The study met its primary objectives by hitting the targeted pharmacokinetic profile, showing a dose-dependent increase in drug levels up to 400 mg and an average half-life of about 12 hours. Additionally, the capsule demonstrated biological activity, with a dose-dependent decrease in inflammatory markers (IL-17 and IL-21), suggesting effective ROCK2 inhibition. These promising results support progression to a Phase 2 study for cerebral cavernous malformations, expected to start in the second half of 2024.
Read Announcement
Free OVID Stock Alerts