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Tofimilast · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| Tofimilast | DRUG | - |
Inclusion Criteria: * Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) * Reversibility to albuterol at least 12% and 200 mL Exclusion Criteria: * Any significant co-morbid disease, particularly cardiovascular * Use of any maintenance therapy except short acting bronchodilators * Smoking h...
Tofimilast is an investigational small molecule being developed for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It has been studied in Phase 2 clinical trials for these indications, though it is not approved and remains in clinical development.
Tofimilast is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with asthma and COPD.
Tofimilast is in Phase 2 clinical development. It has completed two Phase 2 trials, one in adult asthmatics and one in adult patients with chronic obstructive pulmonary disease. The drug is investigational and has not been approved by regulatory authorities.
Tofimilast has been studied in two completed Phase 2 trials. The first, NCT00150397, evaluated its safety and efficacy in 112 adult asthmatics in the United States, Costa Rica, and India. The second, NCT00219622, enrolled 300 adults with COPD across the United States, Argentina, Brazil, Chile, Costa Rica, and Mexico.
No, Tofimilast is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for asthma and chronic obstructive pulmonary disease. The drug is still in clinical development and has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency.