Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP01 · 2 trials · 2 indications
Change in start-to-end difference in cough count, active vs. placebo treatment periods
| Arm | Type | Description |
|---|---|---|
| FP01 6mg or Placebo | EXPERIMENTAL | FP01 6mg Oral |
| FP01 12mg or Placebo | EXPERIMENTAL | FP01 12mg Oral |
| FP01 High dose | EXPERIMENTAL | - |
| FP01 Low dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FP01 | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits * Subjects must be able to read and write English * Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35...
FP01 is an investigational small molecule developed for cough. It has been studied in two Phase 2 trials: one in chronic refractory cough and one in acute cough caused by upper respiratory tract infection. FP01 is not approved for any indication and remains in clinical development.
FP01 is being developed by Avalo Therapeutics, Inc., which trades on the Nasdaq under the ticker AVTX. The company has completed Phase 2 studies of FP01 in cough indications, including a chronic refractory cough trial and an acute cough trial.
FP01 is in Phase 2 development. Two Phase 2 trials have been completed: NCT01703923 in chronic refractory cough and NCT01597349 in acute cough due to upper respiratory tract infection. No later-stage trials are currently active.
FP01 has been evaluated in two completed Phase 2 trials. NCT01703923 studied FP01 lozenges in 83 adults with chronic refractory cough in the United States. NCT01597349 studied FP01 lozenges in 208 adults with acute cough from upper respiratory tract infection in Chile and Peru.
No, FP01 is not FDA approved. It is an investigational small molecule that has completed Phase 2 clinical development for acute cough and chronic refractory cough. Further clinical testing would be required before any regulatory submission.