Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-00610355 · 3 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| PF-00610355 | EXPERIMENTAL | - |
| PF- 00610355 | EXPERIMENTAL | - |
| PF - 00610355 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Salmeterol | ACTIVE_COMPARATOR | - |
| PF -00610355 | EXPERIMENTAL | - |
| PF-00610355 450 µg | EXPERIMENTAL | An orally inhaled dose of PF-00610355 450 µg |
| PF-00610355 1200 µg | EXPERIMENTAL | An orally inhaled dose of PF-00610355 1200 µg |
| moxifloxacin 400 mg | ACTIVE_COMPARATOR | A single oral dose of moxifloxacin 400 mg on Day 4. |
| Name | Type | Description |
|---|---|---|
| PF-00610355 | DRUG | oral, inhaled, dry powder, 600ug, OD |
| PF - 00610355 | DRUG | oral, inhaled, dry powder, 300ug, OD |
| PF- 00610355 | DRUG | oral, inhaled, dry powder, 100ug, OD |
| Placebo | DRUG | oral, inhaled, dry powder, placebo, OD |
| Salmeterol | DRUG | salmeterol, 50ug, BID |
| moxifloxacin | DRUG | A single oral dose of moxifloxacin 400 mg on Day 4. |
Inclusion Criteria: * Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%. * Diagnosis of moderate COPD for a minimum of 6 months. * Stable disease for at least 1 month prior to screening Exclusion Criteria: * More than 2 exacerbations of COPD requiring treatment wit...
PF-00610355 was studied for the treatment of chronic obstructive pulmonary disease (COPD), a chronic lung condition. It was developed as an inhaled small molecule and evaluated in COPD patients, including a Phase 2 trial that enrolled 405 participants across multiple countries. It is an investigational agent and is not an approved therapy.
PF-00610355 targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at this receptor. ADRB2 agonism is the mechanism of bronchodilator drugs used in obstructive airway disease. PF-00610355 is a small molecule designed for inhaled administration in COPD.
PF-00610355 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials of PF-00610355 in COPD and in healthy volunteers.
PF-00610355 is in Phase 1 development overall, with completed Phase 1 and Phase 2 studies. It is an investigational drug and has not been approved by the FDA. Two completed trials are registered, and no trials are currently active.
PF-00610355 has been studied in three completed trials: NCT01107054, a Phase 1 QT/QTc study in 48 healthy volunteers in Belgium; NCT00808288, a Phase 2 COPD trial in 405 patients across the United States, Europe, and South Africa; and NCT00783406, a Phase 2 single-dose COPD trial in 20 patients in Germany.
PF-00610355 and PF00610335 refer to the same compound, written with and without the hyphen. The Phase 1 QT/QTc study NCT01107054 used the spelling PF00610335, while the COPD trials NCT00808288 and NCT00783406 used PF-00610355.