Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CSTI-500 · 1 trial · 1 indication
Maximum observed plasma concentration following drug administration determined directly from the concentration-time profile.
Area under the plasma-drug concentration-time curve from pre-dose (time 0) to 72 hours after drug administration
Area under the plasma-drug concentration-time curve from pre-dose (time 0) extrapolated to infinite time
| Arm | Type | Description |
|---|---|---|
| CSTI-500 10mg | EXPERIMENTAL | All eligible subjects will be administered a single oral dose of CSTI-500 10 mg at Visit 2 |
| Name | Type | Description |
|---|---|---|
| CSTI-500 | DRUG | Single 10 mg capsule |
Inclusion Criteria: * Male and female subjects (13-50 years of age at screening) with a documented medical record history of PWS confirmed by genetic testing. * Subject must have a reliable caregiver/parent to bring the subject to the site for the visits, remain with the subject during visit times ...
CSTI-500 is an investigational small molecule being developed for the treatment of Prader-Willi syndrome, a rare genetic disorder. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CSTI-500 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is currently in Phase 1 clinical development for Prader-Willi syndrome.
CSTI-500 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of CSTI-500 in subjects with Prader-Willi syndrome has been completed.
CSTI-500 has one completed Phase 1 clinical trial, identified as NCT05504395, titled 'A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome.' The study enrolled 10 participants in the United States and was not randomized or double-blinded.
CSTI-500 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical development.