Vanda Pharmaceuticals Provides Update on VQW-765 Clinical Development Program

The VQW-765 development program is on hold pending further analysis of the full dataset.

Rhea-AI Summary

Vanda Pharmaceuticals (VNDA) reported that its Phase III VQW-765 study for on-demand treatment of acute anxiety in adults with social anxiety disorder missed its primary endpoint.

Study 3201 randomized 546 adults to a single oral dose of VQW-765 or placebo before a standardized stress test involving a presentation. The primary endpoint measured female participants' distress during the presentation on a 0–100 scale. Scores were 65.6 with VQW-765 versus 66.0 with placebo, with no statistically significant difference (p=0.8899). The key secondary endpoint in the combined male and female population also failed: scores were 64.7 versus 63.8 (p=0.6605). The results did not confirm earlier Phase II findings of numerically lower stress with VQW-765. VQW-765 was safe and well tolerated. The program is on hold pending further analysis of the full dataset.

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1 major · 4 points

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Positive

• Minor pointVQW-765 was safe and well tolerated in the Phase III study, consistent with prior studies.

Negative

• Major pointPrimary endpoint missed: female distress scores were 65.6 with VQW-765 versus 66.0 with placebo (p=0.8899).
• Moderate pointKey secondary endpoint missed: combined male and female distress scores were 64.7 versus 63.8 with placebo (p=0.6605).
• Moderate pointVQW-765 program is on hold pending further analysis of the full dataset.
• Minor pointPhase III results did not confirm earlier Phase II findings of numerically lower stress with VQW-765.

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Key Figures

Study enrollment: 546 adults Female population LS mean difference: -0.4 (95% CI: -5.32 to 4.62) Female population p-value: 0.8899 +2 more

Study enrollment

546 adults

Phase III Study 3201

Female population LS mean difference

-0.4 (95% CI: -5.32 to 4.62)

Primary endpoint; SUDS performance phase

Female population p-value

0.8899

Primary endpoint; SUDS performance phase

Full population LS mean difference

0.9 (95% CI: -3.00 to 4.73)

Key secondary endpoint; SUDS performance phase

Full population p-value

0.6605

Key secondary endpoint; SUDS performance phase

Key Terms

alpha 7 nicotinic acetylcholine receptor, partial agonist, double-blind, placebo-controlled

4 terms

alpha 7 nicotinic acetylcholine receptor medical

"alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist"

A ligand-gated ion channel made of five identical alpha-7 subunits (often written α7 nAChR) that opens when bound by acetylcholine or similar agonists, allowing sodium, potassium and especially calcium ions to flow across the cell membrane. It is a homomeric nicotinic acetylcholine receptor found on neurons and some non-neuronal cells and mediates fast cholinergic signaling, with roles in neurotransmission, modulation of inflammation and cognitive processes; it characteristically desensitizes rapidly and has high calcium permeability, features that affect how drugs interact with it.

partial agonist medical

"α7-nAChR) partial agonist"

A partial agonist is a drug or molecule that binds to a receptor and activates it, but produces a smaller maximal biological response than a full agonist even when all receptors are occupied; when given alone it produces a limited (submaximal) effect, and when given with a full agonist it can reduce the overall effect by competing for the same receptor sites. This behavior creates a built-in ceiling on response and means a partial agonist can act like an agonist in low-activity systems and like an antagonist in the presence of stronger activators.

double-blind medical

"multicenter, randomized, double-blind, placebo-controlled Phase III study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase III study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

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• Phase III clinical study of VQW-765 in adults with social anxiety disorder did not meet its primary endpoint
• Consistent with prior studies, VQW-765 was safe and well tolerated

WASHINGTON, Oct. 14, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its clinical development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist. Vanda's Phase III clinical study, VP-VQW-765-3201 (Study 3201), which evaluated VQW-765 for the on-demand treatment of acute anxiety in adults with social anxiety disorder, did not meet its primary endpoint.

Study 3201 (NCT07221578)¹ was a multicenter, randomized, double-blind, placebo-controlled Phase III study conducted at approximately 30 clinical sites in the U.S. The study randomized 546 adults 18 to 65 years of age with a current diagnosis of social anxiety disorder and elevated baseline scores on the Liebowitz Social Anxiety Scale and Public Speaking Anxiety Scale. Participants received a single oral dose of VQW-765 or placebo in a 1:1 ratio and were then challenged with a psychosocial stress test, the standardized Trier Social Stress Test (TSST). The TSST induces acute stress by having participants prepare (anticipation phase) and then deliver (performance phase) an interview-style presentation to a panel that gives no feedback or encouragement.

The primary endpoint was the level of distress during the performance phase of the TSST in the female population, as measured by the Subjective Units of Distress Scale (SUDS), on which participants rate their nervousness or distress from 0 to 100, with higher scores indicating greater distress. Female participants who received VQW-765 did not show a statistically significant difference from those who received placebo. The study also did not meet the key secondary endpoint of SUDS during the performance phase of the TSST in the full (male and female) population.

Population	SUDS Performance Phase (Std Err)		LS Mean Difference (95% CI)	P-value
	VQW-765	Placebo
ITT females*	65.6 (1.90)	66.0 (1.96)	-0.4 (-5.32, 4.62)	0.8899
ITT males and females**	64.7 (1.50)	63.8 (1.51)	0.9 (-3.00, 4.73)	0.6605
*Primary endpoint    **Key secondary endpoint

Study 3201 was designed to confirm the findings of Vanda's earlier Phase II clinical study, VP-VQW-765-2201 (Study 2201), in which participants with a history of performance anxiety who received VQW-765 reported numerically lower stress levels during the TSST than those who received placebo. The Phase III results did not confirm those findings.

"We are disappointed that Study 3201 did not confirm the earlier Phase II findings2 for VQW-765 in patients with social anxiety disorder," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "We thank the participants, investigators and site staff who made this study possible."
Given these results, the VQW-765 program is on hold pending further analysis of the full dataset. 

About VQW-765
VQW-765 is a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, with potential use for the treatment of psychiatric disorders. VQW-765 binds and enhances the activity of one type of nicotinic receptors composed of a pentameric assembly of the alpha 7 subtype. While nicotine can also bind this receptor, the binding affinity of VQW-765 is much higher than that of nicotine, making it a potent and specific molecule for the alpha 7 receptor. VQW-765, formerly known as AQW-051, was licensed to Vanda from Novartis.

About Performance Anxiety
Over 20% of the U.S. population is estimated to experience debilitating performance anxiety that ranges from public speaking to test taking, writer's block and musical performance. The most common type of performance anxiety is public speaking anxiety. People with performance anxiety report that the condition can hinder or even threaten their professional career of choice. Similarly, musicians report that performance anxiety makes them perform at levels below their capabilities. Currently, there is no FDA-approved drug treatment available for performance anxiety and general anti-anxiolytic drugs tend to be sedating, which is not preferred in a performance situation.

About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

References
1. ClinicalTrials.gov NCT07221578.
2. He Y, Polymeropoulos CM, Mohrman MA, et al. Efficacy and safety of an alpha 7-nicotinic acetylcholine receptor agonist, VQW-765, in subjects with performance anxiety: randomised, double-blind, placebo-controlled trial. Br J Psychiatry. 2025;227(1):473-480. doi:10.1192/bjp.2025.84

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including but not limited to statements regarding Vanda's clinical development plans for VQW-765; Vanda's clinical development plans for the rest of its late-stage pipeline and the estimated prevalence in the U.S. of performance anxiety are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the outcome of Vanda's analysis of the full dataset from Study 3201; and the accuracy of the estimates of the prevalence in the U.S. of performance anxiety. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:

Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com

Follow us on X @vandapharma

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Vanda's Phase III VQW-765 study show?

Study 3201 did not meet its primary or key secondary endpoint. Female participants receiving VQW-765 had distress scores of 65.6 versus 66.0 with placebo (p=0.8899). In the combined male and female population, scores were 64.7 versus 63.8 (p=0.6605). VQW-765 was safe and well tolerated.

Is Vanda's VQW-765 development program continuing?

The VQW-765 program is on hold pending further analysis of the full dataset following the Phase III results.

How was Vanda's Phase III VQW-765 study conducted?

Study 3201 was a randomized, double-blind, placebo-controlled study at approximately 30 U.S. clinical sites. It enrolled adults aged 18 to 65 with social anxiety disorder and elevated baseline anxiety scores. Participants received VQW-765 or placebo in a 1:1 ratio before preparing and delivering an interview-style presentation to a panel that provided no feedback or encouragement.