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AAE581 · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| AAE581 | DRUG | - |
Inclusion Criteria: * Low spine Bone Mineral Density * 0 to 1 prevalent fracture in non lumber spine Exclusion Criteria: * History or presence of any bone disease other than osteopenia /osteoporosis * Previous treatment with other anti-osteoporosis agent(Wash out required) * Evidence of vitamin D...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
AAE581 is an investigational small molecule being developed for osteoporosis, a condition that weakens bones and increases fracture risk. It is studied in postmenopausal women with osteoporosis or osteopenia. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
AAE581 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of AAE581 in postmenopausal women with osteoporosis.
AAE581 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total enrollment of 836 participants. The drug is investigational and has not received regulatory approval. It is being studied for the treatment of osteoporosis in postmenopausal women.
AAE581 has been evaluated in two completed Phase 2 clinical trials. The first trial, NCT00100607, enrolled 676 postmenopausal women with osteoporosis. The second trial, NCT00170911, enrolled 160 postmenopausal women with osteopenia or osteoporosis. Both trials were completed and were randomized and double-blind.
AAE581 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for osteoporosis. The completed trials have evaluated its safety and efficacy in postmenopausal women, but the drug has not yet received marketing authorization from the FDA or other regulatory agencies.