Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.
相关临床试验
96
15 进行中
药物批准
5
批准总数
监管机构
1
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进行中（未招募）
14
14.6%
Available
1
1.0%
已完成
53
55.2%
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1.0%
招募中
21
21.9%
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4.2%
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- A federal district court ruled it no longer has jurisdiction over Vanda Pharmaceuticals' challenge to the FDA's drug review process. - Judge Amit Mehta stated that Vanda raised the same Appointments Clause arguments in the D.C. Circuit, which would have precedential effect. - The case centers on Vanda's constitutional challenge to the structure of FDA drug approvals under the Appointments Clause. - The ruling effectively shifts the legal battle from the district court to the federal appellate level.
- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will participate in a fireside chat at the B. Riley Securities Mind, Muscle & Vision Summit in Boston, Massachusetts. - The event is scheduled for Thursday, July 16, 2026, as announced by the company on July 10, 2026. - Vanda is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs.
- The FDA granted Rare Pediatric Disease Designation to Vanda's VCA-894A, an investigational antisense oligonucleotide targeting Charcot-Marie-Tooth disease type 2S (CMT2S). - CMT2S is a rare inherited neuromuscular disorder with an estimated prevalence of less than 1 in 1,000,000 worldwide, causing progressive sensory and motor impairment that can lead to loss of ambulation. - VCA-894A is a personalized therapy targeting a unique cryptic splice site variant within the IGHMBP2 gene not yet observed in any other patient. - If VCA-894A meets all statutory requirements and gains approval, Vanda may become eligible to receive a priority review voucher under the Rare Pediatric Disease Priority Review Voucher program.
- Vanda Pharmaceuticals has launched the Thetis study, a Phase 2 clinical trial evaluating NEREUS (tradipitant) for preventing vomiting in patients receiving high-dose GLP-1 receptor agonist therapies. - A previous Phase 2 study demonstrated that tradipitant reduced vomiting by 50% compared to placebo, with only 29.3% of treated patients experiencing vomiting versus 58.6% on placebo. - The trial addresses a significant clinical need as gastrointestinal side effects remain a leading cause of treatment discontinuation for GLP-1 therapies like semaglutide and tirzepatide. - Topline results from the multicenter, randomized, double-blind, placebo-controlled trial are expected by Q4 2026.
- Vanda Pharmaceuticals has submitted a Biologics License Application to the FDA for imsidolimab, a novel IL-36 receptor antagonist for treating generalized pustular psoriasis. - Phase 3 GEMINI trials demonstrated that 53% of patients achieved clear or almost clear skin at 4 weeks compared to 13% on placebo. - The company has requested priority review, which could lead to potential FDA approval as early as mid-2026 for this rare orphan disease. - Imsidolimab showed sustained efficacy over approximately 2 years with monthly maintenance dosing and demonstrated a favorable safety profile.
- The FDA has lifted a partial clinical hold on Vanda Pharmaceuticals' tradipitant for motion sickness, removing the previous 90-dose limitation after determining motion sickness is an acute condition rather than chronic. - The decision eliminates the need for an additional six-month dog toxicity study and allows Vanda to extend clinical studies of the neurokinin-1 receptor antagonist. - Tradipitant's New Drug Application remains on track for FDA review with a December 30, 2025 PDUFA date, potentially becoming the first new pharmacologic motion sickness treatment in over four decades.
- Vanda Pharmaceuticals reported positive Phase 2 results showing tradipitant, an oral NK-1 receptor antagonist, reduced vomiting by 50% in patients receiving GLP-1 therapy for obesity. - The randomized controlled trial of 116 overweight adults demonstrated that 29.3% of tradipitant-treated participants experienced vomiting compared to 58.6% on placebo when given a 1 mg semaglutide dose. - The findings address a critical unmet need as 30-50% of patients discontinue GLP-1 agonists due to gastrointestinal side effects, often before reaching therapeutic doses. - Vanda plans to advance tradipitant into Phase 3 trials in the first half of 2026 as a potential adjunct therapy in the $50+ billion global GLP-1 agonist market.
- AnaptysBio announced plans to separate into two independent public companies by year-end 2026, creating distinct investment opportunities for royalty management and drug development operations. - The royalty management company will focus on substantial revenue streams from Jemperli (dostarlimab) with GSK, which generated $482 million in first-half 2025 sales and carries peak sales guidance exceeding $2.7 billion. - The biopharma operations company will advance three immunology therapeutics including rosnilimab for autoimmune diseases, with Phase 2 ulcerative colitis data expected in late 2025. - GSK's Jemperli royalty structure provides escalating rates from 8% to 25% of net sales, with patent protection extending through 2035-2036 and multiple ongoing registrational trials.
- HETLIOZ (tasimelteon) met its primary endpoint in a multicenter, randomized, double-blind, placebo-controlled trial, showing significant improvements in sleep latency for patients with primary insomnia. - The melatonin receptor agonist demonstrated mean improvements in latency to persistent sleep of 44.9 minutes (20 mg dose) and 46.3 minutes (50 mg dose) versus 28.2 minutes for placebo (p < 0.001). - The drug showed sustained efficacy through follow-up time points and was not associated with cognitive or mood changes, rebound, or withdrawal effects after discontinuation. - Vanda Pharmaceuticals continues to pursue FDA approval for HETLIOZ in insomnia treatment, addressing a condition that affects over 10% of the American population.
- The FDA has granted Orphan Drug Designation to VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor developed by Vanda Pharmaceuticals for treating polycythemia vera. - VGT-1849B utilizes novel OliPass Peptide Nucleic Acid (OPNA) chemistry to selectively target JAK2 mRNA, potentially offering improved safety compared to existing JAK inhibitors that affect multiple kinases. - The antisense oligonucleotide specifically addresses the JAK2 V617F mutation found in over 95% of polycythemia vera patients, with the disease affecting 44-57 per 100,000 people in the United States. - Unlike current JAK inhibitors such as Jakafi, Inrebic, Ojjaara, and Vonjo, VGT-1849B aims to avoid off-target kinase effects that can lead to increased toxicity and adverse side effects.
