Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tasipimidine · 1 trial · 1 indication
Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2
Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2
| Arm | Type | Description |
|---|---|---|
| Tasipimidine Dose level 1 | EXPERIMENTAL | Dose level 1 |
| Tasipimidine Dose level 2 | EXPERIMENTAL | Dose level 2 |
| Tasipimidine Dose level 3 | EXPERIMENTAL | Dose level 3 |
| Placebo | PLACEBO_COMPARATOR | Tasipimidine Placebo |
| Tasipimidine Dose level 4 | EXPERIMENTAL | Dose level 4 |
| Name | Type | Description |
|---|---|---|
| Tasipimidine | DRUG | Tasipimidine solution |
| Tasipimidine placebo | DRUG | Tasipimidine placebo solution |
Inclusion Criteria: * Signed informed consent (IC) for participation in the study. * Male or female subjects with age between 18 and 65 years. * Insomnia disorder * Self-reported history of the following on at least 3 nights per week and for at least 3 months prior to the screening: ≥ 30 minutes to...
| 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 |
Tasipimidine is an investigational small molecule being developed for the treatment of insomnia, a psychiatric condition characterized by difficulty falling or staying asleep. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Tasipimidine is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The company is conducting clinical trials to evaluate the drug's efficacy and tolerability in patients with insomnia.
Tasipimidine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness for treating insomnia.
Tasipimidine has one completed Phase 2 clinical trial registered under NCT06956495, titled 'Efficacy and Tolerability of Tasipimidine in Sleepless Patients.' This randomized, double-blind, placebo-controlled study enrolled 190 participants with insomnia in Finland and has been completed.
No, Tasipimidine is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for insomnia. The drug has completed one clinical trial, but it has not yet received regulatory approval for marketing.