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 drug being developed for the treatment of Alpha1-antitrypsin Deficiency, a rare genetic condition. It is administered via aerosolization and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation for this indication.
Aerosolized, Recombinant Alpha 1-Antitrypsin is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda's stock is listed under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and effects of this investigational drug.
Aerosolized, Recombinant Alpha 1-Antitrypsin is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 55 participants enrolled. The drug is investigational and has not received regulatory approval. It is being studied for the treatment of Alpha1-antitrypsin Deficiency.
Aerosolized, Recombinant Alpha 1-Antitrypsin has been studied in two completed Phase 1 clinical trials. NCT00157092 evaluated its effect on epithelial lining fluid analytes in 15 subjects, and NCT00161707 assessed its safety in 40 subjects. Both trials were conducted in the United States and enrolled adults with Alpha1-antitrypsin Deficiency.
Aerosolized, Recombinant Alpha 1-Antitrypsin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alpha1-antitrypsin Deficiency. The completed trials have focused on safety and biomarker effects, but the drug has not yet received regulatory approval for any use.