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Diazoxide Choline Controlled-Release Tablet
Diazoxide Choline Controlled-Release Tablet is a Potassium channel blocker Small molecule drug developed by Essentialis, Inc.. It is currently in Phase 2 development for Hypertension. Also known as: DCCR.
Potassium channel blocker
Potassium channel blocker Used for Hypertension.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Diazoxide Choline Controlled-Release Tablet |
|---|---|
| Also known as | DCCR |
| Sponsor | Essentialis, Inc. |
| Drug class | Potassium channel blocker |
| Target | ATP-sensitive potassium channels |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
Diazoxide acts by blocking ATP-sensitive potassium channels, leading to vasodilation and increased blood pressure.
Approved indications
- Hypertension
Common side effects
- Hypotension
- Tachycardia
- Nausea
Key clinical trials
- Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period (PHASE3)
- A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome (PHASE3)
- An Open-Label Study of DCCR Tablet in Patients With PWS (PHASE3)
- A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR) (PHASE2)
- Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides (PHASE3)
- Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome (PHASE1, PHASE2)
- Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline (PHASE1)
- Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Diazoxide Choline Controlled-Release Tablet CI brief — competitive landscape report
- Diazoxide Choline Controlled-Release Tablet updates RSS · CI watch RSS
- Essentialis, Inc. portfolio CI
Frequently asked questions about Diazoxide Choline Controlled-Release Tablet
What is Diazoxide Choline Controlled-Release Tablet?
How does Diazoxide Choline Controlled-Release Tablet work?
What is Diazoxide Choline Controlled-Release Tablet used for?
Who makes Diazoxide Choline Controlled-Release Tablet?
Is Diazoxide Choline Controlled-Release Tablet also known as anything else?
What drug class is Diazoxide Choline Controlled-Release Tablet in?
What development phase is Diazoxide Choline Controlled-Release Tablet in?
What are the side effects of Diazoxide Choline Controlled-Release Tablet?
What does Diazoxide Choline Controlled-Release Tablet target?
Related
- Drug class: All Potassium channel blocker drugs
- Target: All drugs targeting ATP-sensitive potassium channels
- Manufacturer: Essentialis, Inc. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Also known as: DCCR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing