The goal of this study is to learn about how the hormone insulin controls blood sugar. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. People with obesity and high insulin levels will receive eight doses of diazoxide, a drug that suppresses the pancreas's production of insulin, and will have their fasting blood sugar and insulin levels checked daily while taking the drug.

Start Date23 Oct 2024

Sponsor / Collaborator

Columbia University

[+2]

NCT06308107

/ RecruitingPhase 1IIT

Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial

This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

Start Date08 Jul 2024

Sponsor / Collaborator

The Johns Hopkins University

NCT04830982

/ WithdrawnPhase 1IIT

A Randomized Placebo Controlled Single Center Phase 1 Study to Evaluate Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

Start Date01 Sep 2023

Sponsor / Collaborator

The Johns Hopkins University

100 Clinical Results associated with Diazoxide

100 Translational Medicine associated with Diazoxide

100 Patents (Medical) associated with Diazoxide

4,603

Literatures (Medical) associated with Diazoxide

26 Jun 2025·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Neonatal hypoglycaemia in the offsprings of parents with maturity-onset diabetes of the young (MODY)

Review

Author: Maly, Jakub ; Urbanova, Jana ; Broz, Jan ; Brunerova, Ludmila ; Musil, Vladimir ; Cerny, Milos

Abstract:

Introduction:

Neonatal hypoglycaemia is the most common metabolic disorder of various causes, relatively rare being MODY (Maturity Onset Diabetes of the Young).

Content:

Data search of relevant articles focused on hypoglycaemia in carriers of selected MODY gene mutations published from 2007 to 2022 was performed in databases Medline, PubMed, Cochrane and UptoDate based on key words: ‘hyperinsulinemic hypoglycaemia’, ‘congenital hyperinsulinism’, ‘MODY’, ‘HNF4A mutation’, ‘HNF1A mutation’.

Summary:

Loss of function of HNF4A and HNF1A genes comprises approximately to 5.9 % of diazoxide responsive hyperinsulinemic hypoglycaemia, which may appear in 15 % HNF4A mutation carriers. A typical finding of HNF4A mutation carriers with neonatal hypoglycaemia was a birth weight above 4000 g or above 97th percentile.

Outlook:

Although mutations in MODY genes represent a rare cause of neonatal hypoglycaemia, they should be considered in the differential diagnosis, particularly in cases of persistent hypoglycaemia requiring intensive care.

19 May 2025·Cureus Journal of Medical Science

Medically Refractory Nesidioblastosis as a Late Adverse Effect of Roux-en-Y Gastric Bypass

Article

Author: Ladna, Michael

A male in his late 40s with a past medical history of morbid obesity status post Roux-en-Y gastric bypass in 2004 presented to the emergency department with recurrent hypoglycemia. The hypoglycemic episodes were triggered by preceding hyperglycemia shortly after a meal. Due to the rapid drop in glucose, he often did not have sufficient time to ingest a rapid-acting carbohydrate snack, resulting in the progression of neuroglycopenic symptoms to syncope. His wife would then immediately administer intramuscular glucagon. A thorough workup did not reveal decompensated liver cirrhosis, chronic kidney disease, congestive heart failure, hypothyroidism, adrenal insufficiency, or insulin use. Serum insulin and C-peptide levels were profoundly elevated. A magnetic resonance imaging (MRI) of the abdomen and pelvis showed no pancreatic mass to suggest an insulinoma. He was referred to interventional radiology (IR) for a selective arterial calcium stimulation test (SACST), which showed an insulin ratio >2 in the gastroduodenal and hepatic arteries, consistent with a diagnosis of nesidioblastosis. He was trialed on numerous medications, which included octreotide, acarbose, diazoxide, and verapamil. He did not tolerate the octreotide due to the adverse effect of worsening abdominal pain and elevated serum lipase consistent with an attack of acute on chronic pancreatitis. The remaining medical regimen was ineffective at preventing hypoglycemia. Although evidence is lacking for use in this context, empagliflozin was then added to prevent the hyperglycemic spikes; however, this too proved ineffective at preventing hypoglycemic episodes. He underwent placement of a percutaneous endoscopic gastrostomy tube intended to tightly control his serum glucose via carbohydrate-low, protein-rich enteral feeds to prevent hyperglycemic episodes; however, this too failed due to suboptimal compliance with oral diet. Endocrinologic surgery declined distal pancreatectomy due to high morbidity and mortality risk with questionable benefit. The patient opted to seek a second opinion at another medical center.

15 May 2025·JCEM Case Reports

Alpelisib Therapy in 2 Patients With Congenital Hyperinsulinism

Article

Author: Hussain, Khalid ; Alburshad, Khalid ; Ibrahim, Marwa ; Amin, Rasha ; Dauleh, Hajar

Abstract:

Congenital hyperinsulinism (CHI) is a disorder of unregulated insulin secretion, leading to severe hypoglycemia in most cases. We previously described the adjunct use of alpelisib therapy in a 3-month-old patient with CHI. We now describe our observations in 2 additional patients with severe CHI treated with alpelisib therapy, resulting in discontinuation of all existing treatments and normalization of feeding. Two children (aged 3 and 4 years) with CHI (homozygous ABCC8 and KCNJ11 pathological variants) who were unresponsive to conventional therapies were treated with alpelisib. Treatment was initiated at 12.5 mg daily, with gradual dose adjustments based on clinical responses. Outcome measures included blood glucose variability, frequency of hypoglycemic episodes, need for supplemental feeding, and treatment safety. In both cases, alpelisib significantly improved glucose levels, reducing the frequency of hypoglycemic episodes. This allowed for the tapering and discontinuation of other medications (diazoxide and octreotide) and facilitated a transition to bolus gastrostomy-tube/oral feeding. No significant adverse effects were reported. Alpelisib shows promise as both an adjunctive and primary therapy for CHI, improving glucose levels and reducing dependence on continuous feeding and other medications. Randomized controlled trials are needed to assess its long-term safety and efficacy for CHI.

News (Medical) associated with Diazoxide

25 Jun 2025

·www.globenewswire.com

Soleno Therapeutics Highlights New Data on VYKAT(TM) XR at the 2025 United in Hope: International Prader-Willi Syndrome Conference

REDWOOD CITY, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, 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. “We believe that these data reveal critical insights on the potential benefit of VYKAT XR to important subpopulations of individuals living with PWS,” said Dr. Anish Bhatnagar, Chief Executive Officer and Chairman of the Board of Soleno Therapeutics. “For those individuals who are managed with strict food controls, these data suggest that they had more hyperphagia symptoms at baseline yet still saw a statistically significant, clinically meaningful benefit from treatment with VYKAT XR. These data also show that VYKAT XR can be safely administered to individuals with PWS who have pre-diabetes or diabetes, providing a benefit despite this co-morbidity.” Data are featured in two poster presentations: Diazoxide Choline Extended-Release Tablets Significantly Reduce Hyperphagia in Patients with PWS Who Are Managed with Strict Food ControlsA primary characteristic of PWS is hyperphagia, a persistent hunger that can lead to aggressive food-seeking behavior. A common practice used in the management of individuals with PWS is to restrict access to food, but this does not address the underlying symptoms of hyperphagia. This poster summarizes an analysis of participants in Soleno’s Phase 3 studies to determine if VYKAT XR can improve hyperphagia symptoms in individuals with PWS considered to be in a highly food restricted environment. After treatment with VYKAT XR, participants in the highly food-restricted group exhibited statistically significant (p ≤ 0.0001), clinically meaningful reductions in HQ-CT Total scores that were often numerically greater than those observed in the less restricted group at all post-baseline timepoints through Year 3. These data demonstrate that individuals with PWS who live with strict food controls are as likely to benefit from treatment with VYKAT XR as those who live with less strict food controls. Safety and Efficacy of Diazoxide Choline Extended-Release in Patients with PWS who Have Pre-Diabetes or DiabetesThis poster summarizes an analysis of the safety and efficacy of VYKAT XR in individuals in Soleno’s Phase 3 clinical trials who had evidence of pre-diabetes or diabetes (PD/DM) at baseline versus those who were normoglycemic. At baseline, 60% of study participants were identified as having evidence of PD/DM. Efficacy was measured using HQ-CT scores and safety was assessed by hyperglycemia-related laboratory values and adverse events (AEs). Efficacy outcomes at Week 156 (p<0.0001) were similar for the PD/DM and normoglycemic groups. As expected, a greater proportion of hyperglycemia-related AEs were reported for participants with PD/DM as compared to those without (42.7% vs 24.0%, respectively), however these events were generally manageable. Treatment-emergent adverse event-related discontinuations rates were similarly low (4.0% in PD/DM individuals vs. 6.0% in normoglycemic individuals) regardless of baseline PD/DM status. These data demonstrate that VYKAT XR can be administered safely and effectively to individuals with PWS who have PD/DM. Importantly, participants treated with VYKAT XR in the Phase 3 studies remained on study and had treatment efficacy, regardless of PD/DM status or occurrence of hyperglycemia-related adverse events. About PWSPrader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term co-morbidities such as diabetes, obesity, and cardiovascular disease. About VYKAT XRVYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). IMPORTANT SAFETY INFORMATION ContraindicationsUse of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions HyperglycemiaHyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid OverloadEdema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse ReactionsThe most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome and was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578 Media Contact:media@soleno.life

Clinical ResultPhase 3Drug Approval

22 May 2025

·www.einpresswire.com

Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome

REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno’s Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older with Prader-Willi syndrome (PWS) who have hyperphagia had been validated by the European Medicines Agency (EMA). “The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,” said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.” Soleno estimates that there are approximately 9,500 patients with PWS in the United Kingdom, France, Germany, Italy and Spain combined 1 . The Company has been granted Orphan Drug Designation for diazoxide choline in the EU for the treatment of PWS, which could provide Soleno with up to 10 years of market exclusivity in the EU, if approved, in addition to certain other regulatory and financial incentives. DCCR was approved by the U.S. Food and Drug Administration (FDA) under the brand name VYKAT™ XR on March 26, 2025. About PWS Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. U.S. INDICATION VYKAT XR is indicated in the U.S. for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ________________________________ 1 Based on mid-point of Orphanet Birth Prevalence rate of 1 in 15,000 to 30,000 IMPORTANT SAFETY INFORMATION Contraindications Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions Hyperglycemia Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid Overload Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse Reactions The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide . About Soleno Therapeutics, Inc. Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome and was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. For more information, please visit www.soleno.life . Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the regulatory approval process for Diazoxide Choline Prolonged-Release Tablets in the EU, the timing of commercialization of Diazoxide Choline Prolonged-Release Tablets in the EU, the potential market opportunity for Diazoxide Choline Prolonged-Release Tablets and the ability of Diazoxide Choline Prolonged-Release Tablets to address the unmet needs of the PWS community. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact: Brian Ritchie LifeSci Advisors, LLC 212-915-2578 Media Contact: media@soleno.life Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalOrphan Drug

15 May 2025

·www.globenewswire.com

Soleno Therapeutics Announces Presentations Featuring VYKAT(TM) XR in Prader-Willi Syndrome at PES 2025

REDWOOD CITY, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today 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. Details of the presentations are as follows: PES 2025 Title: Long-term administration of diazoxide choline extended-release (DCCR) tablets in people with Prader-Willi syndrome: changes in lean body mass and lean mass Index Format: PosterSession: Poster Session 3 Date/Time: May 17, 12:45 - 2:30 PM Presenter: Jack Yanovski, MD PhD Title: Resuming diazoxide choline extended-release (DCCR) after 16-week randomized withdrawal is associated with significant improvements in hyperphagia and behavioral symptoms in PWS (Study C614)Format: PosterSession: Poster Session 3 Date/Time: May 17, 12:45 - 2:30 PM Presenter: Jack Yanovski, MD PhD About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for individuals with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. About VYKAT XRVYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). IMPORTANT SAFETY INFORMATION ContraindicationsUse of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions HyperglycemiaHyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid OverloadEdema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse ReactionsThe most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578 Media Contact:Soleno Therapeutics media@soleno.life 650-213-8444, #2

Drug Approval

100 Deals associated with Diazoxide

External Link

KEGG	Wiki	ATC	Drug Bank
D00294	Diazoxide	V03AH01 C02DA01	DB01119

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypertension	United States	Schering Corp.	22 Jan 1973
Hypoglycemia	United States	Schering Corp.	22 Jan 1973

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	Phase 2	Germany	Neurotec Pharma SL	01 Jun 2011
Multiple Sclerosis, Relapsing-Remitting	Phase 2	Spain	Neurotec Pharma SL	01 Jun 2011
Multiple Sclerosis	Phase 2	Spain	Neurotec Pharma SL	-
Amyotrophic Lateral Sclerosis	Preclinical	Spain	Neurotec Pharma SL	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03566511 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Hyperglycemia	37	Proglycem+placebo (Diazoxide)	zffmtgaabh(szkqjmgkto) = rqniapgzpt vtbyceglmq (lsiznjvtfw, 1.3) View more	-	31 May 2025
				Proglycem+placebo (Matched Placebo)	zffmtgaabh(szkqjmgkto) = uxgddqfjfy vtbyceglmq (lsiznjvtfw, 1.3) View more
NCT01028846 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hyperglycemia	10	Diazoxide (Diazoxide)	xbgfzsfnrv(jgyyvgkhuz) = vjpcqcnsta raaabehukl (ablvbmlejd, 0.13) View more	-	14 Mar 2025
				Placebo (Placebo)	xbgfzsfnrv(jgyyvgkhuz) = lriayqgfjs raaabehukl (ablvbmlejd, 0.17) View more
SAT157 (ENDO2023)	Not Applicable	Chronic Kidney Diseases	4	Diazoxide 50 mg TID	ygyuqvkvuq(xnviytcgpx) = bwksrwwgef qsbxyeksjg (onnymliymm ) View more	Positive	05 Oct 2023
				Diazoxide 70 mg BID	ygyuqvkvuq(xnviytcgpx) = edrutqrxmu qsbxyeksjg (onnymliymm ) View more
PSUN340 (ENDO2022)	Not Applicable	Congenital Hyperinsulinism ABCC8 \| KCNJ11 \| GCK ... View more	2	diazoxide (Case 1)	dgxolhghvs(uhvwbaghyb) = gyrfoznpmz cqaiqppppx (teyhyxejgm ) View more	-	01 Nov 2022
				diazoxide (Case 2)	dgxolhghvs(uhvwbaghyb) = lukdqejsxy cqaiqppppx (teyhyxejgm ) View more
ESPE2022	Not Applicable	Congenital Hyperinsulinism HADH mutation	-	Diazoxide	knbyyttlwm(fdjhybzqxc) = wzlamcaixb eqzfbxyarr (pxzlmhuwvt, 0.9 - 7.1) View more	-	15 Sep 2022
				Diazoxide	vsvzgyqudq(ronxrszteb) = liywsnurmk kdbdonrzqg (slnagjqqmp )
ESPE2022	Not Applicable	Hemochromatosis	99	Diazoxide 2mg/kg/day	ekdvnzfowy(rvbicdkflq) = Adverse events can still be observed with DZX low doses, but at a lower incidence compared to the STD zjlzcwehsa (odwkksqjqk ) View more	Positive	15 Sep 2022
				Diazoxide 3mg/kg/day
ENDO2021	Not Applicable	Glut1 Deficiency Syndrome SLC2A1	1	Diazoxide	pcalymeorn(vjxfwhvxtn) = aypodvvwly lrgmbfgosp (qaudanttzz ) View more	Positive	03 May 2021
				Diazoxide (Ketogenic Diet)	pcalymeorn(vjxfwhvxtn) = ejhllsbjlu lrgmbfgosp (qaudanttzz ) View more
ENDO2021	Not Applicable	Neonatal hypoglycemia	46	Diazoxide	snitznonyy(smmjmdhoed) = aewuceqshb hzqsaovpvo (liljaklvyn ) View more	Positive	03 May 2021
MON-073 (ENDO2020)	Not Applicable	Hyperinsulinism ABCC8 Dominant Mutation	-	Diazoxide (ABCC8 Dominant Mutation)	bnuxjrsjgv(uusjlgdatt) = eagzkicfat fbvpopivdq (kxqkkejucg ) View more	-	08 May 2020
MON-911 (ENDO2020)	Not Applicable	Insulinoma 5-HIAA \| chromogranin A \| IGF-1	-	MON-911 (Insulinoma)	yutcsgxjny(ficyhzvgpm) = xkrkjcaqoi tdkwmumzzo (qnmmmvvldy, 298 - 2350) View more	-	08 May 2020

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis