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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
KUR-101 is an investigational small molecule being developed for the treatment of acute pain. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamic effects in healthy adults.
KUR-101 is being developed by AtaiBeckley Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ATAI. The company is conducting clinical research on this investigational drug for the treatment of acute pain.
KUR-101 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in healthy adult volunteers. The drug remains investigational and has not yet received regulatory approval for any use.
KUR-101 has one completed clinical trial registered under NCT05114265, titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults." This Phase 1 study enrolled 60 participants in New Zealand and was a randomized, double-blind, controlled trial.
KUR-101 is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound in the available clinical trial information. It is being studied specifically for its potential use in treating acute pain.