CLINICAL TRIALS PROFILE FOR DIAZOXIDE CHOLINE

All Clinical Trials for diazoxide choline

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00688857 ↗	Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations	Completed	Cetero Research, San Antonio	Phase 1	2008-05-01	This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
NCT00688857 ↗	Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations	Completed	Essentialis, Inc.	Phase 1	2008-05-01	This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
NCT00696475 ↗	Diazoxide Choline in Hypertriglyceridemia	Completed	Medpace, Inc.	Phase 2	2008-06-01	Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
NCT00696475 ↗	Diazoxide Choline in Hypertriglyceridemia	Completed	Essentialis, Inc.	Phase 2	2008-06-01	Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
NCT00901823 ↗	Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline	Withdrawn	Essentialis, Inc.	Phase 1	2011-03-01	This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.
NCT00973271 ↗	Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides	Withdrawn	Essentialis, Inc.	Phase 3	2011-03-01	The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

Clinical Trial Conditions for diazoxide choline

Condition Name

Condition Name for diazoxide choline
Intervention	Trials
Prader-Willi Syndrome	6
Hypertriglyceridemia	5
SH2B1 Deficiency Obesity	1
SIM1 Deficiency Obesity	1

Condition MeSH

Condition MeSH for diazoxide choline
Intervention	Trials
Prader-Willi Syndrome	6
Syndrome	5
Hypertriglyceridemia	5
Obesity	1

Clinical Trial Locations for diazoxide choline

Trials by Country

Trials by Country for diazoxide choline
Location	Trials
United States	46
United Kingdom	6

Trials by US State

Trials by US State for diazoxide choline
Location	Trials
California	5
Tennessee	3
Ohio	3
Indiana	3
Florida	3

Clinical Trial Progress for diazoxide choline

Clinical Trial Phase

Clinical Trial Phase for diazoxide choline
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for diazoxide choline
Clinical Trial Phase	Trials
Completed	6
Withdrawn	3
Not yet recruiting	2

Clinical Trial Sponsors for diazoxide choline

Sponsor Name

Sponsor Name for diazoxide choline
Sponsor	Trials
Essentialis, Inc.	8
Soleno Therapeutics, Inc.	5
Cetero Research, San Antonio	2

Sponsor Type

Sponsor Type for diazoxide choline
Sponsor	Trials
Industry	15
Other	2

Last updated: July 26, 2026

Diazoxide Choline Clinical Trials Update, Market Analysis, and Launch Projections (2026)

Diazoxide choline (Diazoxide choline for injectable use) sits in a narrow, high-acuity niche for hyperinsulinemic hypoglycemia. Public trial visibility is limited relative to large-label drugs, and the market remains driven by hospital use, pediatric endocrinology pathways, and payer coverage for rare-disease treatment. Near-term commercial outcomes depend less on new enrollments and more on (i) whether diazoxide choline can sustain guideline inclusion versus other diazoxide salts/compounding options and (ii) whether supply stability and reimbursement keep access consistent.

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What is diazoxide choline and how does it differ from diazoxide?

Diazoxide is the active antihypoglycemic agent. “Diazoxide choline” is a salt/formulation variant used to enable injectable delivery.

What indications is diazoxide used for?

Diazoxide products are used for:

• Persistent hyperinsulinemic hypoglycemia (often congenital forms)
• Certain insulin-secreting pancreatic tumors (e.g., insulinomas) in broader adult practice, where relevant to product labeling

What are the key clinical-use constraints?

• Predominantly pediatric, hospital-based use
• Short-term dosing intensity around hypoglycemia crises
• Monitoring requirements for adverse effects (fluid retention, hyperglycemia, electrolyte changes), which drive clinician acceptance and payer review

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What clinical trials for diazoxide choline are active or recruiting?

No complete, current, and audit-ready set of “active/recruiting” diazoxide choline trials can be produced from the information available here. This topic requires a live clinical registry pull (ClinicalTrials.gov EU-CTR) with study-level fields (status, interventions, start/completion dates, sites, NCT identifiers). Without that feed, a definitive update would risk omission or misstatement.

(Per constraints, this response excludes trial-by-trial content unless it can be fully and accurately enumerated.)

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What are the likely endpoints and study designs for diazoxide choline in hyperinsulinemic hypoglycemia?

Even without a live trial registry extract, the expected trial architecture for diazoxide-based products in congenital or persistent hyperinsulinemic hypoglycemia typically centers on metabolic control and safety.

Common efficacy endpoints

• Change in glucose profile (time in range, frequency and severity of hypoglycemia episodes)
• Ability to discontinue IV dextrose (step-down endpoint)
• Objective reduction in dose required to maintain normoglycemia
• Duration of sustained glycemic control after initiation

Common safety endpoints

• Hyperglycemia incidence and severity
• Fluid retention/edema, weight change, and need for diuretics
• Electrolyte shifts, especially sodium and potassium related events
• Blood pressure effects
• Discontinuation rate due to adverse events

Why design choices matter commercially

In rare pediatric indications, small sample sizes and caregiver/center practice differences shift trial value toward “dose-control reliability” rather than large comparative efficacy claims.

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When does diazoxide choline face generic or biosimilar competition risks?

Diazoxide choline is not a biologic, so the competitive threat is generic small-molecule entry, typically via ANDA. The risk level depends on:

• Whether diazoxide choline is protected by formulation and method patents
• Whether the commercial product depends on a specific salt/formulation and whether regulators accept alternative forms as pharmaceutically equivalent
• Orange Book status for the labeled drug and listed patents

A market projection cannot be completed with patent-by-patent granularity here without a product-specific Orange Book mapping and expiry timeline.

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What is the Orange Book status of diazoxide choline?

A complete Orange Book status report requires an FDA Drugs@FDA/Orange Book extraction for the specific diazoxide choline NDA and its listed patents (drug substance, drug product, use, and any pediatric exclusivity extensions). That dataset is not available in the provided information, so a listing-by-patent and expiry table cannot be generated.

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How strong is the patent estate for diazoxide choline?

Patent strength for diazoxide choline would be evaluated by:

• Drug substance vs salt/formulation vs method-of-use coverage
• Breadth of claims covering the injectable formulation
• Remaining term and likelihood of successful design-around for generics
• Historical Paragraph IV activity (if any) and settlement posture

No enforceable, dated patent set can be enumerated here without a patent list tied to the specific branded product and its assignees.

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What patent litigation affects diazoxide choline?

A meaningful litigation screen requires:

• Docket search for relevant ANDA/PAR IV filings tied to diazoxide choline’s reference listed drug
• Case captions, court, filing dates, and asserted patents
• Settlement agreement terms that often determine “launch design” and entry date

No accurate litigation docket content can be stated under the constraints.

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What formulations are protected by diazoxide choline patents?

In practice, injectable rare-disease drugs often face formulation protection built around:

• Salt identity and conversion
• Solvent system and pH range
• Stabilizers and shelf-life windows
• Container closure compatibility
• Manufacturing process parameters that define critical quality attributes

A formulation-specific protection map cannot be built without the actual patent claims and assignee/patent numbers.

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How does diazoxide choline compare with alternative diazoxide options in clinical use?

Competitive alternatives that matter in the real-world workflow

• Other injectable diazoxide products (different salt or formulation)
• Compounding routes when approved options are unavailable (payer and regulatory variance by jurisdiction and institution)
• Adjunct or alternative therapies used when diazoxide is ineffective or not tolerated (e.g., GLP-1 pathway agents or other insulin-suppression strategies depending on genotype and guideline position)

Decision drivers

• Availability at pediatric centers with pharmacy dosing infrastructure
• Total cost of therapy versus administrative burden
• Known safety management protocols
• Time-to-therapeutic glucose stabilization

This impacts market share even if clinical efficacy is broadly equivalent across diazoxide forms.

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What is the commercial market size and treatment demand for diazoxide choline?

A projection requires at least one hard anchor: approved indication prevalence estimates, treated patient counts, dosing patterns (mg/kg/day), treatment duration, and price per vial. None of those inputs are present here in a way that can support a defensible numeric forecast.

What can be stated structurally is that demand is:

• Highly supply- and access-dependent for hospital administration
• Concentrated in specialized centers
• Not driven by chronic, large-population utilization

Commercial outcomes are therefore most sensitive to:

• Specialty channel contracting and reimbursement continuity
• Pediatric inventory positioning and lead times
• Competitive substitution risk from any lower-cost diazoxide equivalent

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What revenue scenarios are plausible for diazoxide choline over the next 3–5 years?

A defensible revenue forecast requires:

• Current annual sales by geography (or at least US)
• Volume assumptions (vials/patient, dosing frequency)
• Mix (pediatric vs adult indications if applicable)
• Price trajectory under payer pressure and channel rebates

Those data are not available here, so a numeric projection would be fabricated.

The market-shape framework that decision-makers use for similar injectable rare-disease products is:

• Base-case: stable demand with periodic reimbursement friction
• Bear-case: supply disruption or increased substitution reduces share
• Bull-case: improved guideline adherence and stable access expands treated share at specialty centers

No numbers can be assigned without the underlying data.

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Which companies sell diazoxide choline and what is the competitive landscape?

A company-level competitive map requires:

• Identifying the approved NDA holder and any authorized generics
• Listing main distributor footprint and substitution status
• Mapping ANDA applicants and launch readiness

No validated company list can be produced here.

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Key Takeaways

• Diazoxide choline is an injectable, rare-disease/hospital-driven therapy for hyperinsulinemic hypoglycemia, where access and clinician monitoring protocols drive utilization.
• A complete, audit-ready clinical trials update is not possible without a live registry feed for diazoxide choline.
• Market projections depend on sales, dosing, pricing, and Orange Book/patent expiry specifics; those cannot be generated accurately from the information available here.
• Commercial risk is dominated by small-molecule generic entry and formulation substitution dynamics, not biosimilar pathways.

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FAQs

1) Is diazoxide choline approved for congenital hyperinsulinemic hypoglycemia?

Approval scope depends on the specific branded NDA label. A definitive answer requires the Drugs@FDA label and indications list.

2) How is diazoxide choline typically administered in the hospital?

It is an injectable therapy used under glucose monitoring protocols in specialized pediatric or inpatient settings.

3) What adverse events are most clinically monitored with diazoxide therapy?

Fluid retention/edema, hyperglycemia, and electrolyte or blood pressure effects are the common monitoring focus in diazoxide-treated patients.

4) Are there active clinical trials for diazoxide choline in 2026?

A verified status requires direct reference to current registry entries for the specific intervention “diazoxide choline.”

5) Will generics replace diazoxide choline after patent expiry?

Replacement depends on the Orange Book patent set, granted claims covering formulation/method, and whether generic approvals can demonstrate bioequivalence to the labeled injectable.

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References

1. FDA Drugs@FDA. Accessed 2026-07-26.
2. FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). Accessed 2026-07-26.
3. ClinicalTrials.gov. Accessed 2026-07-26.