Proglycem (diazoxide)
An approved treatment for Congenital Hyperinsulinism.
The same compound appears under different names depending on the context. Here is how to identify Diazoxide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Diazoxide
- Brand name
- Proglycem
- Drug class
- KATP channel opener
- Manufacturer
- Teva Pharmaceuticals (Proglycem); generics from Par Health and e5 Pharma
- How it's taken
- Oral suspension, 2 or 3 times a day
The only FDA-approved medicine for low blood sugar caused by too much insulin in infants and children, and the first-line treatment for congenital hyperinsulinism. A chocolate-mint oral suspension given 2 or 3 times a day; generic versions are available.
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Where Diazoxide fits
First-line medicine for every child with a confirmed diagnosis of hyperinsulinism (2024 international guideline, Grade 1). Roughly half of children respond, according to Children's Hospital of Philadelphia. Children who do not respond move to octreotide or a long-acting somatostatin analog, continuous feeds, and an 18F-DOPA PET scan to look for a focal lesion that surgery can cure.
How Diazoxide works
In congenital hyperinsulinism the pancreas keeps releasing insulin even when blood sugar is low. Insulin release is controlled by a gate on the beta cell called the KATP channel: when the gate is open the cell stays quiet, and when it closes the cell fires and lets insulin out. Diazoxide props that gate open.
It works well when the gate itself is intact, which is why children with changes in genes such as GLUD1, HNF4A, HNF1A and HADH usually respond, and why most children with 2 recessive changes in the KATP genes ABCC8 or KCNJ11, whose gate is missing or broken, do not. The label describes a blood sugar rise beginning within an hour and lasting up to about 8 hours, so it is dosed 2 or 3 times a day.
Doctors judge response by whether the child can fast safely and make ketones before the sugar falls; the 2024 international guideline says to stop if the IV dextrose cannot be cut back after 5 days at 15 mg/kg/day.
Mechanism: Opens the ATP-sensitive potassium (KATP) channel on pancreatic beta cells, which keeps the cell from firing and stops insulin release
Side effects and safety
- Fluid retention. Diazoxide makes the body hold salt and water; in a child or adult with a weak heart this can cause heart failure, so a diuretic is usually given alongside it.
- Necrotizing enterocolitis in newborns and infants. A serious bowel inflammation reported after marketing, including deaths in newborns (label revised October 2026); watch for new feeding problems, vomiting, a swollen belly, bloody stools or lethargy and stop the drug if suspected.
- Pulmonary hypertension in newborns and infants. Reported after marketing and reversible when the drug was stopped; watch for breathing trouble, especially in babies with other risk factors.
- Ketoacidosis or hyperosmolar coma. Usually during another illness; can come on fast, and because the drug lasts about 30 hours, watching must continue for days after an episode.
- Low platelets or white cells. Thrombocytopenia may require stopping the drug; neutropenia is usually brief and does not raise infection risk.
- Thiazide interaction. Other thiazide-type water pills can strengthen the blood sugar and uric acid effects; the drug is also contraindicated in anyone allergic to thiazides.
- Blood glucose closely until stable, then periodically
- Urine glucose and ketones during long-term use, especially when sick
- Kidney tests (BUN, creatinine clearance) and electrolytes
- Blood counts (hematocrit, platelets, white cells)
- Liver enzyme AST and uric acid
- Breathing and feeding in newborns, for pulmonary hypertension and necrotizing enterocolitis
The label calls sodium and fluid retention the most frequent serious reaction, most common in young infants and adults, and it can tip a weak heart into heart failure, so specialists usually start a water pill (chlorothiazide or hydrochlorothiazide) at the same time. Excess fine body hair on the forehead, back and limbs is common in children and goes away after the drug is stopped.
Other frequent effects are high blood sugar or sugar in the urine, poor appetite, nausea, vomiting, belly pain, diarrhea, a fast heartbeat and high uric acid. Two warnings matter most for babies: reversible pulmonary hypertension, and necrotizing enterocolitis, a serious bowel inflammation, which the label updated in October 2026 to note has included fatal cases in newborns.
Diabetic ketoacidosis has happened during other illnesses and the drug stays in the body for about 30 hours, so families are taught to check urine glucose and ketones and to call about increased thirst, frequent urination or fruity breath.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Diazoxide
Proglycem is a 50 mg per mL chocolate-mint oral suspension with a dropper marked for 10 mg to 50 mg; shake well and protect from light. The label's starting dose for infants and newborns is 8 mg/kg a day split into 2 or 3 doses, raised if needed to a maximum of 15 mg/kg a day; for older children and adults it is 3 mg/kg a day up to 8 mg/kg a day.
Treatment starts under close observation with frequent blood sugar checks, usually for several days. If it has not worked after 2 to 3 weeks the label says to stop it, and HI specialists usually decide within about 5 days at the top dose. A diuretic is commonly prescribed with it to limit fluid retention.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
An old small-molecule drug sold as a flavored oral suspension; brand Proglycem and at least 2 generic suspensions compete. Cost pressure for families usually comes from the diuretic, feeding supplies and glucose monitoring rather than the drug itself.
Help paying for Proglycem
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Free medicine program
Proglycem (diazoxide) oral suspension is on the Teva Cares Foundation medicine list. Free medicine for US residents with a valid prescription whose total pre-tax household income is at or below 300% of the federal poverty level. Applicants must disclose any insurance; those under 150% of the poverty level must include a Medicare Extra Help (LIS) denial, and if a plan required a prior authorization or formulary exception the outcome letter must be attached. Patient and prescriber both sign the application.
For: no insurance, underinsured, Medicare, private insurance · source - Insurance and case manager help
Teva Cares Foundation phone line 1-877-237-4881, Monday to Friday 9 AM to 8 PM Eastern, and an online portal at tevacaresportal.org for applications and status. No application or delivery fee.
For: private insurance, Medicare, Medicaid, no insurance, underinsured · source
Good to know: Brand Proglycem only. No copay card exists; proglycem.com redirects to the prescribing information. Generic diazoxide oral suspension from Par Health (ANDA 210799) and e5 Pharma (ANDA 211050) has no manufacturer program found. Congenital Hyperinsulinism International (congenitalhi.org) says it has programs for families who have difficulty obtaining necessary medications and supplies and runs a CGM Access Program for the US and Canada. Marked partial because income rules beyond 300% FPL and any insurance-specific exclusions are only in the application form.
How congenital hyperinsulinism treatments compare
Diazoxide (Proglycem) is the only medicine the FDA has approved for hyperinsulinism. Octreotide is the usual next step but is used off-label, and the 2 investigational drugs shown are not approved for anyone outside a trial. Your HI team chooses based on the gene result, whether diazoxide works, and whether a focal lesion can be removed by surgery.
Congenital Hyperinsulinism has 1 FDA-approved treatment: Proglycem (and generics) (diazoxide, approved 1976). Also compared, not FDA-approved for congenital hyperinsulinism: Sandostatin (off-label) (octreotide, Off-label (approved 1988 for acromegaly)); Ersodetug (investigational) (ersodetug (RZ358), Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026)); Dasiglucagon pump (investigational) (dasiglucagon, Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026). Proglycem (and generics) is typically used as first-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive katp gene changes.
| Drug | How it works | How it’s given | How often | Where you get it | Typical use | FDA status |
|---|---|---|---|---|---|---|
Proglycem (and generics) diazoxide You are here | KATP channel opener: props open the beta cell's potassium gate so it cannot fire and release insulin | Oral suspension by dropper or syringe | Twice or 3 times a day | Home, after a hospital start with close glucose checks | First-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive KATP gene changes | 1976 |
Sandostatin (off-label) octreotide | Somatostatin analog: dampens insulin release even when the KATP gate is broken | Injection under the skin or continuous pump; monthly octreotide LAR or lanreotide once stable | Several times a day or continuous; monthly for long-acting forms | Home injections or pump after hospital training; clinic for monthly depot shots | Second-line when diazoxide fails or is not tolerated, usually with feeds, while focal versus diffuse disease is sorted out | Off-label (approved 1988 for acromegaly) |
Ersodetug (investigational) ersodetug (RZ358) | Insulin receptor antibody: lets insulin be released but blocks its effect on the body's cells | Infusion (intravenous in the Phase 2 study) | Every 2 weeks at first, then every 4 weeks in the Phase 3 trial | Trial sites only | Studied as an add-on for children and adults with lows despite standard care; could work regardless of gene | Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026) |
Dasiglucagon pump (investigational) dasiglucagon | Stable glucagon analog: tells the liver to release stored sugar to offset the extra insulin | Continuous infusion under the skin from a wearable pump | Around the clock | Trial sites only; designed for hospital start then home | Studied to cut IV dextrose in newborns and to reduce lows in children not controlled by medicines or surgery | Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026 |
This chart is for understanding, not medical advice. Only diazoxide is FDA-approved for hyperinsulinism; octreotide is prescribed off-label by HI specialists, and ersodetug and dasiglucagon are investigational and available only in clinical studies. Feeds, IV dextrose, emergency glucagon and surgery are also central to HI care and are not shown here. Always discuss options with a hyperinsulinism center.
Clinical trial results
Diazoxide was approved in 1976 on evidence from the era before modern trial design, and there is no placebo-controlled trial in congenital hyperinsulinism. What is well documented is who responds: in a 417-child Children's Hospital of Philadelphia cohort, gene changes were found in 91% of diazoxide-unresponsive children, almost all in ABCC8, KCNJ11 or GCK, and in 47% of responsive children, where GLUD1 and dominant KATP changes were most common.
The 2024 international guideline rates diazoxide a Grade 1 first-line recommendation and notes the World Health Organization added it to its essential medicines list.
Development history
Diazoxide was first developed as a blood pressure medicine and was found to raise blood sugar by blocking insulin release. The FDA approved Proglycem oral suspension on May 28, 1976 (NDA 017453); Teva markets it today. Generic diazoxide oral suspensions from Par Health (ANDA 210799) and e5 Pharma (ANDA 211050) followed. The label gained a pulmonary hypertension warning for infants and, in October 2026, a necrotizing enterocolitis warning.
A different salt, diazoxide choline (Vykat XR), was approved in 2025 for hunger in Prader-Willi syndrome and is not interchangeable with Proglycem.
Explore Congenital Hyperinsulinism trials
Other Congenital Hyperinsulinism treatments
Common questions about Diazoxide
▸What is Diazoxide (Proglycem)?
The only FDA-approved medicine for low blood sugar caused by too much insulin in infants and children, and the first-line treatment for congenital hyperinsulinism. A chocolate-mint oral suspension given 2 or 3 times a day; generic versions are available.
▸How does Diazoxide work?
In congenital hyperinsulinism the pancreas keeps releasing insulin even when blood sugar is low. Insulin release is controlled by a gate on the beta cell called the KATP channel: when the gate is open the cell stays quiet, and when it closes the cell fires and lets insulin out. Diazoxide props that gate open. It works well when the gate itself is intact, which is why children with changes in genes such as GLUD1, HNF4A, HNF1A and HADH usually respond, and why most children with 2 recessive changes in the KATP genes ABCC8 or KCNJ11, whose gate is missing or broken, do not. The label describes a blood sugar rise beginning within an hour and lasting up to about 8 hours, so it is dosed 2 or 3 times a day. Doctors judge response by whether the child can fast safely and make ketones before the sugar falls; the 2024 international guideline says to stop if the IV dextrose cannot be cut back after 5 days at 15 mg/kg/day.
▸What are the side effects of Diazoxide?
The label calls sodium and fluid retention the most frequent serious reaction, most common in young infants and adults, and it can tip a weak heart into heart failure, so specialists usually start a water pill (chlorothiazide or hydrochlorothiazide) at the same time. Excess fine body hair on the forehead, back and limbs is common in children and goes away after the drug is stopped. Other frequent effects are high blood sugar or sugar in the urine, poor appetite, nausea, vomiting, belly pain, diarrhea, a fast heartbeat and high uric acid. Two warnings matter most for babies: reversible pulmonary hypertension, and necrotizing enterocolitis, a serious bowel inflammation, which the label updated in October 2026 to note has included fatal cases in newborns. Diabetic ketoacidosis has happened during other illnesses and the drug stays in the body for about 30 hours, so families are taught to check urine glucose and ketones and to call about increased thirst, frequent urination or fruity breath.
▸How is Diazoxide taken?
Proglycem is a 50 mg per mL chocolate-mint oral suspension with a dropper marked for 10 mg to 50 mg; shake well and protect from light. The label's starting dose for infants and newborns is 8 mg/kg a day split into 2 or 3 doses, raised if needed to a maximum of 15 mg/kg a day; for older children and adults it is 3 mg/kg a day up to 8 mg/kg a day. Treatment starts under close observation with frequent blood sugar checks, usually for several days. If it has not worked after 2 to 3 weeks the label says to stop it, and HI specialists usually decide within about 5 days at the top dose. A diuretic is commonly prescribed with it to limit fluid retention.
▸Is Diazoxide FDA approved?
Yes, Diazoxide (Proglycem) is FDA approved (1976) for the treatment of Congenital Hyperinsulinism.
▸Is diazoxide FDA-approved for congenital hyperinsulinism?
Yes. Proglycem's label covers hypoglycemia due to hyperinsulinism in infants and children, naming the older terms for the condition (islet cell hyperplasia, nesidioblastosis, leucine sensitivity). It has been approved since 1976 and is the only approved drug for the disease.
▸What does diazoxide-responsive mean?
It means the child's blood sugar can be held above 70 mg/dL on diazoxide without extra IV dextrose, and the child can fast safely and make ketones. HI teams usually test this within about 5 days at the top dose. Children who are unresponsive most often have changes in the KATP genes ABCC8 or KCNJ11 and are evaluated for focal disease and surgery.
▸Why is a water pill given with diazoxide?
Diazoxide makes the body hold salt and water, which in babies can cause swelling and strain the heart and lungs. The 2024 international guideline recommends starting chlorothiazide or hydrochlorothiazide at the same time, especially at doses above 10 mg/kg a day.
▸Is there a generic for Proglycem?
Yes. Generic diazoxide oral suspension is sold by Par Health and e5 Pharma. Vykat XR is a different diazoxide product (diazoxide choline, extended-release tablets) approved only for Prader-Willi syndrome and is not a substitute.
▸What side effects should parents watch for?
Swelling or fast breathing (fluid retention or pulmonary hypertension), new feeding problems, vomiting, a swollen belly or bloody stools (necrotizing enterocolitis, added to the label in October 2026), and signs of very high blood sugar such as heavy thirst, frequent urination or fruity breath. Extra body hair is common and reversible.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration (Drugs@FDA) · 2026-10-06. PROGLYCEM (diazoxide) oral suspension prescribing information, Rev. 10/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017453s025lbl.pdf
- U.S. Food and Drug Administration. PROGLYCEM, NDA 017453, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017453
- Hormone Research in Paediatrics · 2024. International Guidelines for the Diagnosis and Management of Hyperinsulinism. https://pubmed.ncbi.nlm.nih.gov/37454648/
- Journal of Clinical Endocrinology and Metabolism · 2013. Genotype and phenotype correlations in 417 children with congenital hyperinsulinism. https://pubmed.ncbi.nlm.nih.gov/23275527/
- Children's Hospital of Philadelphia. Congenital Hyperinsulinism. https://www.chop.edu/conditions-diseases/congenital-hyperinsulinism
- Teva Cares Foundation. Medicines covered by the Teva Cares Foundation Patient Assistance Program. https://www.tevacares.org/medicines/