Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APD125 · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| APD125 | DRUG | soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks |
| Placebo | DRUG | soft gelatin capsule, daily dosing for up to 3 weeks |
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| ResMed Inc. | RMD | 1 | N/A | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | - | Daridorexant, Non-orexin receptor antagonist medications for insomnia |
APD125 is an investigational small molecule being developed for the treatment of insomnia, including primary insomnia. It is a psychiatry therapeutic area drug that has been studied in Phase 2 clinical trials for these sleep disorders.
APD125 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical development for insomnia.
APD125 is in Phase 2 clinical development. It has completed two Phase 2 trials, one with 173 participants and another with 744 participants, both focused on insomnia and primary insomnia. The drug is not yet approved and remains investigational.
APD125 has been studied in two completed Phase 2 trials. The first, NCT00452179, evaluated safety and efficacy in 173 patients with insomnia. The second, NCT00664664, assessed efficacy in 744 patients with sleep maintenance insomnia. Both trials are completed.
APD125 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for insomnia and primary insomnia. Further clinical development and regulatory review would be required before any approval could be considered.