This section highlights FDA-related milestones and regulatory updates for drugs developed by Neuphoria Therapeutics (NEUP).
Over the past two years, Neuphoria Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BNC210 and BNC-210. 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.
BNC210 FDA Regulatory Events
BNC210 is a drug developed by Neuphoria Therapeutics for the following indication: For the acute, as-needed treatment of social anxiety disorder (SAD).
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:
- BNC210
- Announced Date:
- October 20, 2025
- Indication:
- For the acute, as-needed treatment of social anxiety disorder (SAD).
Announcement
Neuphoria Therapeutics Inc. announced that the AFFIRM-1 Phase 3 trial of BNC210 for the acute treatment of social anxiety disorder (SAD) did not meet its primary endpoint of change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS) scores.
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BNC-210 FDA Regulatory Events
BNC-210 is a drug developed by Neuphoria Therapeutics for the following indication: Social Anxiety Disorder (SAD).
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:
- BNC-210
- Announced Date:
- September 4, 2025
- Indication:
- Social Anxiety Disorder (SAD)
Announcement
Neuphoria Therapeutics Inc announced the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class, acute, "as needed", fast-acting treatment for social anxiety disorder (SAD).
AI Summary
Neuphoria Therapeutics Inc. has reached its target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial of BNC-210, a first-of-its-kind, as-needed, fast-acting treatment for social anxiety disorder. This milestone moves the study toward its first Phase 3 results, expected in early fourth quarter.
BNC-210 is an oral, proprietary modulator of the α7 nicotinic acetylcholine receptor. It has FDA Fast Track designation for acute social anxiety disorder and PTSD. Earlier trials showed it produces rapid, broad anti-anxiety effects without sedation, cognitive impairment, or addiction potential.
The AFFIRM-1 study is multicenter, double-blind, and placebo-controlled. Participants receive a single 225 mg dose of BNC-210 or placebo one hour before a public speaking challenge. The main outcome measures changes in distress using the Subjective Units of Distress Scale (SUDS) during the speech and related anxiety scales.
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