Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AF056 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AF056 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male, non-smoking patients between 18 and 35 years of age (both inclusive). * Patients with fmr1 full mutation (\> 200 CGG repeats) * Patients with a Clinical Global Impression Severity Score (CGI-S) of \> 4 (moderately ill) * Patients with a score of \>20 in the ABC-C scale (...
AF056 is an investigational small molecule being developed for the treatment of Fragile X Syndrome, a rare genetic condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
AF056 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
AF056 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for its efficacy, safety, and tolerability in patients with Fragile X Syndrome.
AF056 has been studied in one completed Phase 2 clinical trial, identified as NCT00718341. This trial evaluated the efficacy, safety, and tolerability of AF056 in 30 male patients with Fragile X Syndrome, aged 18 years and older, across France, Italy, and Switzerland.
Yes, AF056 is also known as AFQ056. The clinical trial NCT00718341, which studied the drug in Fragile X Syndrome patients, uses the name AFQ056 in its official title.