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Trichostatin A · Now - Nov 24, 2026 Now · Phase 2 · Onychomycosis of Toenail
Recently reported
Tradipitant Phase 3Positive · 2026-10-27
VP-VLY-686-3601 · nausea and vomiting, obesity
Primary: Any vomiting (incidence of vomiting) in Study 3601 after a single 1 mg semaglutide dose without titration — 43.0% (61/142) on NEREUS (tradipitant) vs 58.5% (96/164) on placebo (p=0.006, adjusted for site), a 27% relative reduction
· Key secondary (any vomiting with worst nausea >=3): 33.1% (47/142) vs 50.6% (83/164) on placebo (p=0.002), a 35% relative reduction
· Frequent multi-day vomiting (>2 episodes on more than one day): 6.3% (9/142) vs 15.9% (26/164) (p=0.008), a 60% relative reduction (post hoc/supportive)
· Extreme vomiting (>10 total episodes): 2.8% (4/142) vs 14.6% (24/164) (p=0.0003), an 81% relative reduction (post hoc/supportive)
· Study design: Phase 3 randomized, placebo-controlled, single 1 mg semaglutide dose without titration; n=142 tradipitant, 164 placebo
· Vanda plans to discuss results with the FDA and is planning a supplemental NDA (sNDA) for prevention of vomiting associated with GLP-1 receptor agonist therapy
Safety: Generally well tolerated, safety consistent with prior studies, no new safety signals
Primary: Level of distress (SUDS, 0-100) during the performance phase of the Trier Social Stress Test in the female population — No statistically significant difference vs placebo: VQW-765 LS mean 65.6 (SE 1.90) vs placebo 66.0 (SE 1.96), LS mean difference -0.4 (95% CI -5.32, 4.62), p=0.8899
· Key secondary (full male+female population) also missed: LS mean difference 0.9 (95% CI -3.00, 4.73), p=0.6605; VQW-765 64.7 vs placebo 63.8
· Randomized 546 adults aged 18 to 65 with social anxiety disorder, 1:1, single oral dose, at approximately 30 U.S. sites (Study 3201, NCT07221578)
· Results did not confirm the earlier Phase 2 Study 2201 findings in performance anxiety
· VQW-765 program is on hold pending further analysis of the full dataset
Safety: Safe and well tolerated, consistent with prior studies
Primary: Level of distress (SUDS, 0-100) during the performance phase of the Trier Social Stress Test in the female population — No statistically significant difference vs placebo: VQW-765 LS mean 65.6 (SE 1.90) vs placebo 66.0 (SE 1.96), LS mean difference -0.4 (95% CI -5.32, 4.62), p=0.8899
· Key secondary (full male+female population) also missed: LS mean difference 0.9 (95% CI -3.00, 4.73), p=0.6605; VQW-765 64.7 vs placebo 63.8
· Randomized 546 adults aged 18 to 65 with social anxiety disorder, 1:1, single oral dose, at approximately 30 U.S. sites (Study 3201, NCT07221578)
· Results did not confirm the earlier Phase 2 Study 2201 findings in performance anxiety
· VQW-765 program is on hold pending further analysis of the full dataset
Safety: Safe and well tolerated, consistent with prior studies
Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Partnerships Eli Lilly and Company: exclusive worldwide license (Apr 2012) to develop and commercialize NEREUS for all human uses
Indications
Prevention of vomiting induced by motion(Approved)
Prevention of vomiting in patients receiving GLP-1 receptor agonist therapies(Phase 3)
Gastroparesis(Stage not disclosed)
Atopic dermatitis(Stage not disclosed)
Catalysts
— None
Status note NDA approved Dec 2025; early commercial launch initiated May 2026 via direct-to-consumer web portal (nereus.us). FDA issued a final order refusing to approve the NDA for gastroparesis (petition for review filed Mar 2026); FDA placed a partial clinical hold on a 52-week open-label gastroparesis safety study (lawsuit filed Apr 2026).
Status note FDA approved in Q1 2026; launch expected in the second half of 2026. Protected by data exclusivity through February 20, 2031 and multiple patents.
HETLIOZ
Approved · Active
Aliases tasimelteon
Target MT1/MT2
Partnerships Bristol-Myers Squibb: license agreement (milestone met on Jan 2014 NDA approval)
Status note NDA approved Jan 2014 for Non-24. FDA issued a final order refusing to approve the sNDA for insomnia (petition for review filed Apr 2025).
Quimilza
Phase 3 · ActiveModality: IL-36R antagonist
Aliases imsidolimab
Target IL-36R
Partnerships AnaptysBio: exclusive global license (Jan 2025) for worldwide rights to develop, manufacture and commercialize Quimilza
Indications
Generalized pustular psoriasis (GPP)(Phase 3)
Catalysts
— None
Status note BLA under FDA review (PDUFA Dec 12, 2026); pivotal study results published in NEJM Apr 28, 2026. Orphan drug designation in Japan (MHLW, May 2026); positive EMA COMP opinion (Jul 2026).
Partnerships Novartis Pharma AG: settlement agreement; all US and Canadian rights in the Fanapt franchise transferred Dec 31, 2014; 3% royalty paid directly to Sanofi
Indications
Acute treatment of manic or mixed episodes associated with bipolar I disorder; schizophrenia(Approved)
Status note Marketed commercial product.
PONVORY
Approved · Active
Aliases ponesimod
Target S1P1
Indications
Relapsing forms of multiple sclerosis (adults)(Approved)
Status note Marketed commercial product.
Per-asset detail extracted from the 10-Q filed 2026-08-06. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Sponsor-matched active trials from ClinicalTrials.gov (20 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.