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Soleno Therapeutics Inc (SLNO)
NASDAQ:SLNO
DCCR
Prader-Willi Syndrome
Phase III
Active Not Recruiting
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
Jan 18, 2023
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DCCR (Diazoxide Choline) Extended-Release Tablets
Sh2b1 Deficiency Obesity, Obesity Associated With Pcsk1 Mutation (Rs6232 Variant), Sim1 Deficiency Obesity
Phase II
Unknown
An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities
Sep 04, 2022
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DCCR
Prader-Willi Syndrome
Phase III
Completed
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
Sep 27, 2018
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Soleno Therapeutics Inc (SLNO) have in its pipeline
SLNO is currently developing the following drugs: DCCR, DCCR (Diazoxide Choline) Extended-Release Tablets, DCCR. These drug candidates are in various stages of clinical development as the company works toward FDA approval.