This section highlights FDA-related milestones and regulatory updates for drugs developed by Vanda Pharmaceuticals (VNDA).
Over the past two years, Vanda Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bysanti, HETLIOZ, Tradipitant, VCA-894A, and VGT-1849A. 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.
Bysanti FDA Regulatory Events
Bysanti is a drug developed by Vanda Pharmaceuticals for the following indication: For the Treatments of Acute Bipolar I Disorder and Schizophrenia.
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:
- Bysanti
- Announced Date:
- May 5, 2025
- Estimated Event Date Range:
- February 21, 2026 - February 21, 2026
- Target Action Date:
- February 21, 2026
- Indication:
- For the Treatments of Acute Bipolar I Disorder and Schizophrenia
Announcement
Vanda Pharmaceuticals Inc announced that The FDA has set February 21, 2026 as the target date for decision on this application.
AI Summary
Vanda Pharmaceuticals Inc. announced that the FDA has set February 21, 2026, as the target date for a decision on its New Drug Application (NDA) for Bysanti™ (milsaperidone). This date marks an important milestone for the company as it awaits approval for this new chemical entity.
Bysanti™ is being developed as a treatment for bipolar I manic and mixed episodes and schizophrenia. The NDA review process is moving forward with no potential issues identified at this stage. The FDA’s decision target date provides clarity on the review timeline, giving both healthcare professionals and investors insight into when an approval decision might be made. Vanda views this as a positive step in the continued development of Bysanti™, as the company works toward expanding treatment options in psychiatric care.
Read Announcement- Drug:
- Bysanti
- Announced Date:
- May 5, 2025
- Indication:
- For the Treatments of Acute Bipolar I Disorder and Schizophrenia
Announcement
Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified.
AI Summary
Vanda Pharmaceuticals Inc. announced that the FDA has accepted its New Drug Application (NDA) for Bysanti™ (milsaperidone) without identifying any potential review issues at this time. The target date for the FDA's decision is set for February 21, 2026.
Bysanti™, a new chemical entity and active metabolite of iloperidone, has shown bioequivalence to iloperidone in clinical studies conducted at both low and high doses. This important finding supports the efficient development and review of the drug, which is intended to treat conditions such as bipolar I disorder and schizophrenia. The data from these studies underlines Bysanti’s efficacy and safety, and it offers promising prospects for further therapeutic exploration. Vanda’s progress with Bysanti™ marks a significant step forward in its mission to develop innovative treatments for complex psychiatric conditions.
Read Announcement- Drug:
- Bysanti
- Announced Date:
- March 31, 2025
- Indication:
- For the Treatments of Acute Bipolar I Disorder and Schizophrenia
Announcement
Vanda Pharmaceuticals Inc. announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia.
AI Summary
Vanda Pharmaceuticals Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for its new drug Bysanti™ (milsaperidone). The company is seeking approval for this atypical antipsychotic to treat acute bipolar I disorder and schizophrenia. The NDA is backed by several clinical studies designed to demonstrate the drug's efficacy and safety, with Bysanti™ expected to work by targeting various neurotransmitter receptors in the brain, including alpha-adrenergic, serotonin, and dopamine receptors.
If approved, Bysanti™ could become available for sale in the United States as early as 2026, with patent exclusivity potentially extending into the 2040s. This step marks a significant milestone for Vanda's efforts to address high unmet medical needs with innovative therapeutic options.
Read Announcement
HETLIOZ FDA Regulatory Events
HETLIOZ is a drug developed by Vanda Pharmaceuticals for the following indication: For treat jet lag disorder.
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:
- HETLIOZ
- Announced Date:
- August 18, 2025
- Indication:
- For treat jet lag disorder
Announcement
Vanda Pharmaceuticals Inc. announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. FDA, case no. 24-1049).
Read Announcement
Tradipitant FDA Regulatory Timeline and Events
Tradipitant is a drug developed by Vanda Pharmaceuticals for the following indication: Tradipitant is a neurokinin-1 receptor antagonist.
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:
- Tradipitant
- Announced Date:
- January 27, 2025
- Indication:
- Tradipitant is a neurokinin-1 receptor antagonist
Announcement
Vanda Pharmaceuticals Inc. today provides an update on the tradipitant development program.
AI Summary
Vanda Pharmaceuticals Inc. announced an update on its tradipitant development program for treating gastroparesis, a disorder where the stomach empties too slowly. The company has been studying tradipitant for nearly 10 years and has treated over a thousand patients in controlled studies and a long-term expanded access program. Tradipitant is designed as a neurokinin 1 receptor antagonist and has shown promise in reducing nausea, one of the most troublesome symptoms of gastroparesis. While one of the controlled studies reported statistically significant improvement over placebo, another study showed similar benefits for both groups. Despite these mixed results, Vanda remains confident in the potential of tradipitant to offer a needed treatment option, especially for patients who have had few alternatives in more than 40 years. The company continues its efforts to advance the drug, aiming to improve the lives of those affected by this challenging condition.
Read Announcement- Drug:
- Tradipitant
- Announced Date:
- January 8, 2025
- Indication:
- Tradipitant is a neurokinin-1 receptor antagonist
Announcement
Vanda Pharmaceuticals Inc. letter to FDA Commissioner highlights faulty gastroparesis NDA review.
AI Summary
Vanda Pharmaceuticals sent a letter to FDA Commissioner Robert Califf, calling out what it described as a faulty review process for its tradipitant New Drug Application, aimed at treating gastroparesis. Vanda argued that the Complete Response Letter issued on September 18, 2024, ignored clear scientific evidence and expert data. The company claimed that the review process lacked proper engagement with the facts it had presented and failed to offer adequate explanations for the rejection.
Moreover, Vanda criticized the failure of Dr. Nikolov to respond to its concerns and highlighted the agency’s refusal to convene an advisory committee meeting for further discussion. The letter stressed that these issues undermine transparency and public trust, calling on the FDA to correct its procedures to better align with scientific evidence and uphold the law.
Read Announcement- Drug:
- Tradipitant
- Announced Date:
- September 19, 2024
- Indication:
- Tradipitant is a neurokinin-1 receptor antagonist
Announcement
Vanda Pharmaceuticals Inc. today provided an update on its tradipitant development program.
AI Summary
Vanda Pharmaceuticals Inc. provided an update on its tradipitant development program. The company emphasized that their latest data from two placebo-controlled studies, published in peer-reviewed journals, supports tradipitant’s effectiveness for patients with gastroparesis. Additional evidence comes from a large open-label study and real-world experience with patients treated under an expanded access program, reinforcing the drug’s favorable benefit-risk profile.
Vanda remains committed to pursuing marketing authorization for tradipitant to address a significant unmet need in gastroparesis, a condition that greatly affects daily life. In conjunction with these efforts, the company plans to submit a separate New Drug Application later this year for tradipitant’s use in preventing vomiting in motion sickness. This update highlights Vanda’s ongoing dedication to developing innovative therapies to improve patient outcomes.
Read Announcement- Drug:
- Tradipitant
- Announced Date:
- May 15, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Tradipitant is a neurokinin-1 receptor antagonist
Announcement
Vanda Pharmaceuticals Inc announced that New Drug Application expected to be submitted in Q4 2024
AI Summary
Vanda Pharmaceuticals Inc. has announced a significant milestone in its drug development plans. The company expects to submit its New Drug Application in the fourth quarter of 2024. This step is crucial as it marks the company’s progress towards gaining approval for a promising new treatment. The anticipated submission reflects Vanda’s commitment to advancing its research and development efforts, while also addressing unmet medical needs.
The upcoming application, which will be reviewed by the FDA, is seen as a key point in the company’s strategy to enhance its portfolio and improve patient care. Industry experts and investors are watching closely, as the successful approval of this application could lead to broader market opportunities and impact future treatment options. Overall, this development places Vanda Pharmaceuticals in a promising position as they prepare for the next phase of regulatory review and potential commercialization.
Read Announcement- Drug:
- Tradipitant
- Announced Date:
- May 15, 2024
- Indication:
- Tradipitant is a neurokinin-1 receptor antagonist
Announcement
Vanda Pharmaceuticals Inc announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness
AI Summary
Vanda Pharmaceuticals Inc. announced positive results from its second Phase III study in motion sickness, which supports their earlier findings from two efficacy studies. The new data confirms that tradipitant is effective at preventing vomiting associated with motion sickness, reinforcing the potential of the drug as a valuable treatment option.
The study’s results highlight tradipitant’s promising role in managing the uncomfortable symptoms of motion sickness. By confirming the benefits seen in previous clinical trials, Vanda Pharmaceuticals strengthens the argument for the drug’s use as a potential therapeutic option. These findings add to the growing body of evidence that tradipitant may eventually offer relief for individuals who suffer from severe motion sickness, marking a significant step forward in treatment development.
Read Announcement
VCA-894A FDA Regulatory Events
VCA-894A is a drug developed by Vanda Pharmaceuticals for the following indication: Antisense oligonucleotide (ASO) with a mechanism of action that specifically targets a cryptic splice site variant within immunoglobulin mu-binding protein 2 (IGHMBP2).
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:
- VCA-894A
- Announced Date:
- June 10, 2025
- Indication:
- Antisense oligonucleotide (ASO) with a mechanism of action that specifically targets a cryptic splice site variant within immunoglobulin mu-binding protein 2 (IGHMBP2).
Announcement
Vanda Pharmaceuticals Inc. announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S).
AI Summary
Vanda Pharmaceuticals Inc. announced the first dose in a first-in-human clinical trial testing VCA-894A, an antisense oligonucleotide (ASO) therapeutic aimed at treating Charcot-Marie-Tooth disease Type 2S (CMT2S). This rare disorder is caused by a unique variant in the IGHMBP2 gene and leads to progressive muscle weakness and loss of motor function. The patient, who was diagnosed with this rare subtype at the age of 5, represents a highly individualized case of the disease, which affects fewer than 1 in 1,000,000 people worldwide.
VCA-894A has shown promising potential in laboratory models by restoring normal gene expression using a patient-derived neuromuscular junction system. This clinical trial marks an important step towards personalized therapies that target specific genetic changes, offering hope to patients with rare genetic disorders like CMT2S.
Read Announcement- Drug:
- VCA-894A
- Announced Date:
- April 7, 2025
- Indication:
- Antisense oligonucleotide (ASO) with a mechanism of action that specifically targets a cryptic splice site variant within immunoglobulin mu-binding protein 2 (IGHMBP2).
Announcement
Vanda Pharmaceuticals Inc announced participation at the American Academy of Neurology (AAN) Annual Meeting, to be held in San Diego, California from April 5 through April 9, 2025.
AI Summary
Vanda Pharmaceuticals Inc. has announced its participation in the American Academy of Neurology (AAN) Annual Meeting in San Diego, California, scheduled from April 5 through April 9, 2025. At this event, Vanda will showcase breakthrough research using a patient-specific organ-on-a-chip model as part of their poster presentation session on April 9. The study, led by Dr. Sandra Paulina Smieszek, focuses on VCA-894A—a novel therapeutic developed for a specific genetic mutation related to Charcot-Marie-Tooth disease type 2S (CMT2S). Researchers demonstrated that VCA-894A improved neuromuscular function, reducing muscle fatigue and enhancing the communication between motor neurons and skeletal muscle cells. The treatment, which has received orphan designation from the FDA, represents a promising advancement in precision medicine and highlights how innovative testing methods can lead to tailored therapies for rare genetic disorders.
Read Announcement
VGT-1849A FDA Regulatory Events
VGT-1849A is a drug developed by Vanda Pharmaceuticals for the following indication: JAK2 inhibitor for the treatment of polycythemia vera (PV).
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:
- VGT-1849A
- Announced Date:
- December 20, 2024
- Indication:
- JAK2 inhibitor for the treatment of polycythemia vera (PV)
Announcement
Vanda Pharmaceuticals Inc announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans.1
AI Summary
Vanda Pharmaceuticals Inc. announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor developed to treat polycythemia vera (PV). PV is a rare blood disorder, estimated to affect about 1 in 2000 Americans, and is driven by a JAK2 V617F mutation that leads to excessive production of blood cells and inflammation.
VGT-1849A is designed to target only JAK2, reducing its activity and potentially lowering the harmful effects associated with overproduction of red blood cells and other blood components. This selective approach may help avoid the off-target effects observed with current small molecule inhibitors that impact multiple proteins. The orphan designation provides benefits such as regulatory support, marking a significant milestone in developing precision treatments for hematologic malignancies like PV.
Read Announcement
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