Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KUR-101 · 1 trial · 1 indication
Measured by the incidence of treatment-emergent adverse events
Measured using the cold pressor test
| Arm | Type | Description |
|---|---|---|
| Part 1: Single ascending dose | EXPERIMENTAL | Single dose of oral KUR-101 or oral placebo |
| Part 2: Three-way crossover | EXPERIMENTAL | Single dose of oral KUR-101, oral placebo and oral OxyNorm |
| Name | Type | Description |
|---|---|---|
| KUR-101 | DRUG | Single oral dose of KUR-101 |
| OxyNorm | DRUG | Single oral dose of OxyNorm |
| Placebo | DRUG | Single oral dose of placebo |
Inclusion Criteria: * Healthy male and female subjects; * Between 18 and 55 years of age; * Provide a signed EC-approved consent form; * Generally healthy, in the opinion of the Investigator; * Body Mass Index (BMI) 18 to 32 kg/m\^2; * Using method of contraception; * Willing and able to comply wit...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
KUR-101 is an investigational small molecule being developed by AtaiBeckley Inc. for acute pain. It has completed a Phase 1 clinical trial in healthy adult volunteers. KUR-101 is not approved for any indication and remains in clinical development.
KUR-101 is being developed for the treatment of acute pain. Its only clinical study to date enrolled healthy adult volunteers rather than patients with acute pain, so its use in patients has not been established. KUR-101 is investigational and has not been approved for any use.
KUR-101 is being developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company sponsored the Phase 1 study of KUR-101 conducted in New Zealand.
KUR-101 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study was a randomized, double-blind, controlled trial that enrolled 60 healthy adult participants.
KUR-101 has been studied in one completed Phase 1 trial, NCT05114265, titled a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of KUR-101 in healthy adults. It enrolled 60 participants in New Zealand and included randomization, double blinding, and a controlled design.
No. KUR-101 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA or any other regulatory agency. Its only completed trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamic effects in healthy adult volunteers.