This section highlights FDA-related milestones and regulatory updates for drugs developed by Bright Minds Biosciences (DRUG).
Over the past two years, Bright Minds Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BMB‑201 and BMB-101. 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.
BMB‑201 FDA Regulatory Events
BMB‑201 is a drug developed by Bright Minds Biosciences for the following indication: Validated Preclinical Vascular Headache Model.
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:
- BMB‑201
- Announced Date:
- September 4, 2025
- Indication:
- Validated Preclinical Vascular Headache Model
Announcement
Bright Minds Biosciences Inc. announced compelling preclinical results for its investigational compound BMB‑201, in a validated isosorbide dinitrate (ISDN) rat model of vascular headache. BMB-201 produced statistically significant reductions in facial mechanical allodynia across both male and female cohorts at 1 and 2 hours post-dose, compared to vehicle, and demonstrated greater effect sizes than sumatriptan at multiple timepoints.
AI Summary
Bright Minds Biosciences reported strong preclinical data for BMB-201 in an isosorbide dinitrate (ISDN) rat model of vascular headache. When given to male and female rats, BMB-201 significantly reduced facial mechanical allodynia at both 1 and 2 hours after dosing compared to a control treatment. In head-to-head tests against sumatriptan, BMB-201 showed larger effect sizes at multiple timepoints, including higher periorbital pain thresholds in males (86% vs. 81% at 1 hour; 53–64% vs. 44% at 2 hours) and females (76–100% vs. 56% at 1 hour; 80% vs. 63% at 2 hours).
These results were statistically significant (p < 0.05) and consistent across sexes, supporting the compound’s potential as a 5-HT2A/2C receptor agonist for headache and migraine treatment. The data underpin plans to advance BMB-201 into clinical development for vascular pain disorders.
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BMB-101 FDA Regulatory Events
BMB-101 is a drug developed by Bright Minds Biosciences for the following indication: In adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
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:
- BMB-101
- Announced Date:
- September 12, 2024
- Indication:
- In adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
Announcement
Bright Minds Biosciences Inc. announced the initiation of the BREAKTHROUGH Study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
AI Summary
Bright Minds Biosciences has initiated the BREAKTHROUGH Study, an open-label Phase 2 clinical trial to assess BMB-101 in adults with refractory forms of epilepsy, including classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE). BMB-101 is a novel, highly selective 5-HT2C receptor agonist that uses a G-protein biased mechanism, aiming to offer improved efficacy and reduced tolerance issues compared to existing treatments. The study will enroll approximately 20 adult participants, who will first undergo a 4‑week baseline period to document seizure activity. Participants will then receive treatment for 8 to 12 weeks, followed by a 4‑week follow-up phase to assess lasting effects. The trial’s primary goals are to evaluate the safety, tolerability, and efficacy of BMB-101 by monitoring changes in seizure frequency and EEG patterns, potentially offering a new treatment option for patients with drug-resistant epilepsy disorders.
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