Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aerosolized, Recombinant Alpha 1-Antitrypsin · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Aerosolized, Recombinant Alpha 1-Antitrypsin | DRUG | - |
Inclusion Criteria: * Signed Informed Consent * Male or female 18 years of age or older * Documented, endogenous plasma AAT levels \< 11 µM (\< 80 mg/dL), either obtained from the medical history or, if not documented, plasma AAT measured after 28 day washout of any prior replacement therapy * Forc...
Aerosolized, Recombinant Alpha 1-Antitrypsin is an investigational inhaled therapy being developed by Takeda Pharmaceutical Company Limited for Alpha1-antitrypsin Deficiency. It is designed to be delivered directly to the lungs as an aerosol. The drug is in Phase 1 clinical development and has been studied in two completed trials.
Aerosolized, Recombinant Alpha 1-Antitrypsin is being studied as a treatment for Alpha1-antitrypsin Deficiency, a rare genetic condition. The clinical program has evaluated its safety and its effect on epithelial lining fluid analytes in adults with the condition. It remains investigational and has not been approved for commercial use.
Aerosolized, Recombinant Alpha 1-Antitrypsin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this inhaled recombinant therapy in Alpha1-antitrypsin Deficiency.
Aerosolized, Recombinant Alpha 1-Antitrypsin is in Phase 1 clinical development. Both of its completed trials were Phase 1 studies. The drug is investigational and has not been approved by the FDA or any regulatory agency for the treatment of Alpha1-antitrypsin Deficiency.
Aerosolized, Recombinant Alpha 1-Antitrypsin has been evaluated in two completed Phase 1 trials: NCT00161707, a safety study in 40 subjects with Alpha1-antitrypsin Deficiency, and NCT00157092, which studied the effect on epithelial lining fluid analytes in 15 subjects. Both trials were conducted in the United States and are now completed.