This section highlights FDA-related milestones and regulatory updates for drugs developed by Soleno Therapeutics (SLNO).
Over the past two years, Soleno Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DCCR, Diazoxide, and VYKAT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DCCR - FDA Regulatory Timeline and Events
DCCR is a drug developed by Soleno Therapeutics for the following indication: For patients with Prader-Willi syndrome (PWS).
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:
- DCCR
- Announced Date:
- November 26, 2024
- Estimated Event Date Range:
- March 27, 2025 - March 27, 2025
- Target Action Date:
- March 27, 2025
- Indication:
- For patients with Prader-Willi syndrome (PWS).
Announcement
Soleno Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. The new Prescription Drug User Fee Act (PDUFA) target action date is March 27, 2025.
AI Summary
Soleno Therapeutics announced that the U.S. Food and Drug Administration (FDA) has extended its review period for the New Drug Application (NDA) related to DCCR (diazoxide choline) extended-release tablets. This treatment is aimed at individuals four years and older with Prader-Willi syndrome (PWS) who experience hyperphagia, a condition marked by an overwhelming drive to eat. The extension resulted from the FDA’s review of recent responses to information requests, which they considered a major amendment to the NDA. As a result, the new Prescription Drug User Fee Act (PDUFA) target action date has been set for March 27, 2025. The FDA did not raise any concerns regarding safety, efficacy, or manufacturing, and the extension provides the agency with additional time to complete a thorough review of the updated data submitted by Soleno Therapeutics.
Read Announcement- Drug:
- DCCR
- Announced Date:
- June 28, 2024
- Indication:
- For patients with Prader-Willi syndrome (PWS).
Announcement
Soleno Therapeutics, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.
AI Summary
Soleno Therapeutics recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead candidate, DCCR (diazoxide choline) extended-release tablets. This medication is designed for treating Prader-Willi syndrome (PWS) in individuals aged four years and older who suffer from hyperphagia, a severe condition characterized by an overwhelming and persistent hunger. DCCR aims to address this life-threatening appetite along with other symptoms of PWS. The drug also benefits from special designations such as Breakthrough Therapy, Fast Track, and Orphan Drug Designation in both the U.S. and European Union, which highlights its potential to meet an unmet need in treating this rare disorder. Additionally, Soleno has requested a Priority Review, which could significantly shorten the FDA’s review timeline if the application is accepted within the 60-day window.
Read Announcement
Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) - FDA Regulatory Timeline and Events
Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) is a drug developed by Soleno Therapeutics for the following indication: Prader-Willi syndrome (PWS).
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:
- Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS)
- Announced Date:
- August 27, 2024
- Indication:
- Prader-Willi syndrome (PWS)
Announcement
Soleno Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.
AI Summary
Soleno Therapeutics, a clinical-stage biopharmaceutical company focused on rare diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for DCCR. This application is for DCCR’s use in treating Prader-Willi syndrome (PWS) in patients aged four years and older who experience hyperphagia—a serious, life-threatening condition marked by an insatiable appetite.
The FDA granted a Priority Review for the NDA, setting a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024. In its Priority Review Designation letter, the FDA also mentioned plans to hold an advisory committee meeting to discuss the application further. This regulatory milestone reflects the agency’s recognition of PWS as a serious condition and highlights the potential of DCCR to provide important improvements in the treatment of hyperphagia in PWS.
Read Announcement- Drug:
- Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS)
- Announced Date:
- August 27, 2024
- Estimated Event Date Range:
- December 27, 2024 - December 27, 2024
- Target Action Date:
- December 27, 2024
- Indication:
- Prader-Willi syndrome (PWS)
Announcement
Soleno Therapeutics, The FDA granted Priority Review for the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
AI Summary
Soleno Therapeutics, Inc. announced that the FDA has accepted its New Drug Application (NDA) for DCCR, a drug aimed at treating Prader-Willi syndrome in individuals aged four and older with hyperphagia. The FDA granted the NDA Priority Review, meaning the agency sees the treatment as a potential significant improvement over current options for a serious condition.
In addition, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024. This milestone indicates the agency's commitment to a timely review and further evaluation of the drug. The FDA is also planning an advisory committee meeting to discuss the application, showing its proactive approach in addressing the needs of patients affected by Prader-Willi syndrome.
Read Announcement- Drug:
- Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS)
- Announced Date:
- April 29, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- 2024-H1
- Indication:
- Prader-Willi syndrome (PWS)
Announcement
Soleno Therapeutics, announced that Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024
AI Summary
Soleno Therapeutics has announced that it is on track to submit a New Drug Application (NDA) for its DCCR treatment in mid-2024. The NDA submission is a major step forward in the company’s efforts to bring a new therapy to market for Prader-Willi syndrome (PWS), a rare genetic disorder that causes severe hyperphagia among other symptoms. The submission follows promising data from the Phase 3 clinical program, suggesting that DCCR may offer significant benefits over current treatment options for PWS patients aged four and older. This planned submission highlights Soleno’s commitment to advancing medical treatments and providing safer and more effective options for patients with this serious condition. The company is focused on final preparations to meet the mid-2024 timeline, a critical milestone in the regulatory process.
Read Announcement- Drug:
- Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS)
- Announced Date:
- April 29, 2024
- Indication:
- Prader-Willi syndrome (PWS)
Announcement
Soleno Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia.
AI Summary
Soleno Therapeutics announced that the FDA has granted Breakthrough Therapy Designation to its investigational drug diazoxide choline for treating hyperphagia in patients with genetically confirmed Prader-Willi syndrome (PWS). This designation applies to both adults and children aged 4 years and older and is based on positive preliminary data from the Phase 3 clinical development program. The agency’s decision signifies that the drug may offer substantial improvement on important clinical endpoints compared to existing therapies, highlighting the serious nature of PWS and the potential benefits of this treatment.
The designation is a milestone for the DCCR clinical program and supports Soleno’s plan to submit a New Drug Application by mid-2024. This step underscores the company’s commitment to addressing the unmet medical needs of patients suffering from the significant challenges associated with PWS.
Read Announcement
VYKAT XR - FDA Regulatory Timeline and Events
VYKAT XR is a drug developed by Soleno Therapeutics for the following indication: To Treat Hyperphagia in Prader-Willi Syndrome.
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:
- VYKAT XR
- Announced Date:
- July 1, 2025
- Indication:
- To Treat Hyperphagia in Prader-Willi Syndrome
Announcement
Soleno Therapeutics, announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets, previously known as DCCR, have been selected for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025), which is being held July 12-15, 2025, in San Francisco, CA.
AI Summary
Soleno Therapeutics recently announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets have been selected for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) in San Francisco, CA. Held from July 12-15, 2025, this prominent conference will showcase the latest research in endocrine health. One of the abstracts, led by Dr. Ashley Shoemaker from Vanderbilt University Medical Center, focuses on the glycemic outcomes achieved over four years of using VYKAT™ XR for treating hyperphagia in individuals with Prader-Willi syndrome. The other abstract, also presented by Dr. Shoemaker, explores the occurrence of peripheral edema during long-term treatment over 4.5 years. These presentations aim to provide deeper insights into the drug's effectiveness and safety, offering promising updates on managing the challenging symptoms of Prader-Willi syndrome.
Read Announcement- Drug:
- VYKAT XR
- Announced Date:
- June 25, 2025
- Indication:
- To Treat Hyperphagia in Prader-Willi Syndrome
Announcement
Soleno Therapeutics today highlighted new data on VYKATTM XR (diazoxide choline) extended-release tablets, previously known as DCCR, at the 2025 United in Hope: International Prader-Willi Syndrome Conference.
AI Summary
Soleno Therapeutics recently presented promising new data on its VYKAT™ XR (diazoxide choline) extended-release tablets at the 2025 United in Hope: International Prader-Willi Syndrome Conference. Formerly known as DCCR, VYKAT™ XR is designed to address hyperphagia, a key challenge for individuals with Prader-Willi syndrome. The data showed that the treatment provided statistically significant and clinically meaningful improvements in hyperphagia symptoms, even in patients who were under strict food control measures. Moreover, the analysis highlighted that the drug can be safely used in patients with pre-diabetes or diabetes while still offering clear benefits. These findings suggest that VYKAT™ XR could be a vital treatment option for a broad range of individuals with Prader-Willi syndrome, helping to improve their quality of life and manage the persistent hunger associated with the condition.
Read Announcement- Drug:
- VYKAT XR
- Announced Date:
- May 15, 2025
- Indication:
- To Treat Hyperphagia in Prader-Willi Syndrome
Announcement
Soleno Therapeutics announced poster presentations from its VYKATTM XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, clinical development program for the treatment of hyperphagia associated PWS at the Pediatric Endocrine Society (PES) Meeting 2025, which is being held May 15-18, in National Harbor, Maryland.
AI Summary
Soleno Therapeutics has announced poster presentations for its VYKAT™ XR (diazoxide choline) extended-release tablets clinical program at the Pediatric Endocrine Society (PES) Meeting 2025 in National Harbor, Maryland. The posters will detail the long-term use of VYKAT XR in patients with Prader-Willi syndrome (PWS), focusing on changes in lean body mass and improvements in behavioral symptoms related to hyperphagia, a severe, life-threatening condition marked by an overwhelming hunger and food-seeking behavior. Led by Dr. Jack Yanovski, the sessions scheduled for May 17 will highlight data on how resuming treatment after a 16-week randomized withdrawal can enhance patient outcomes. This clinical program, previously known as DCCR, aims to provide a once-daily treatment option for both adults and children aged four and older suffering from hyperphagia associated with PWS, ultimately aiming to improve quality of life.
Read Announcement- Drug:
- VYKAT XR
- Announced Date:
- April 14, 2025
- Indication:
- To Treat Hyperphagia in Prader-Willi Syndrome
Announcement
Soleno Therapeutics, Inc announced the U.S. commercial availability of VYKAT™ XR (diazoxide choline) extended-release tablets, the company's treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025.
AI Summary
Soleno Therapeutics, Inc. announced that VYKAT™ XR (diazoxide choline) extended-release tablets are now commercially available in the U.S. This new treatment, approved by the FDA on March 26, 2025, targets hyperphagia—a condition marked by an extreme, persistent hunger—in patients with Prader-Willi syndrome (PWS) aged four and older. As the first FDA-approved therapy to address hyperphagia in PWS patients, VYKAT XR represents a significant advance. The company has begun distributing prescriptions to patients, marking an important step in providing much-needed treatment for a condition that poses serious health risks and is a burden for both patients and caregivers.
According to CEO Anish Bhatnagar, M.D., this launch aligns with Soleno’s commitment to improving access to innovative therapies for the PWS community and meeting the demand for effective treatment options for hyperphagia.
Read Announcement- Drug:
- VYKAT XR
- Announced Date:
- March 26, 2025
- Indication:
- To Treat Hyperphagia in Prader-Willi Syndrome
Announcement
Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).
AI Summary
Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). This breakthrough marks the first approved therapy targeting the persistent, life-disrupting hunger experienced by individuals with PWS, providing a much-needed option to manage a condition that has long challenged families and caregivers. The FDA approval was based on robust data from a Phase 3 clinical study that showed significant benefits for patients treated with VYKAT XR compared to those on placebo. Soleno Therapeutics expects the treatment to be available in the U.S. beginning in April 2025, offering hope for improved quality of life for those affected by hyperphagia in the PWS community.
Read Announcement
