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Placebo for DCCR
Placebo for DCCR is a Small molecule drug developed by Soleno Therapeutics, Inc.. It is currently in Phase 3 development for DCCR-related conditions.
This drug is a placebo for DCCR, meaning it has no active therapeutic effect.
This drug is a placebo for DCCR, meaning it has no active therapeutic effect. Used for DCCR-related conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Placebo for DCCR |
|---|---|
| Sponsor | Soleno Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, it does not interact with any biological pathways or receptors, and its primary purpose is to serve as a control in clinical trials.
Approved indications
- DCCR-related conditions
Common side effects
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)
- Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides (PHASE3)
- 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:
- Placebo for DCCR CI brief — competitive landscape report
- Placebo for DCCR updates RSS · CI watch RSS
- Soleno Therapeutics, Inc. portfolio CI
Frequently asked questions about Placebo for DCCR
What is Placebo for DCCR?
How does Placebo for DCCR work?
What is Placebo for DCCR used for?
Who makes Placebo for DCCR?
What development phase is Placebo for DCCR in?
Related
- Manufacturer: Soleno Therapeutics, Inc. — full pipeline
- Indication: Drugs for DCCR-related conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing