Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL343 · 4 trials · 2 indications
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
Maximum observed concentration (Cmax) of DNL343 in plasma
Time to maximum observed concentration (Tmax) of DNL343 in plasma
Terminal elimination half-life (t1/2) of DNL343 in plasma
| Arm | Type | Description |
|---|---|---|
| 14C-DNL343 | EXPERIMENTAL | - |
| DNL343 (High Dose) | EXPERIMENTAL | - |
| DNL343 (Low Dose) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Cohort C | EXPERIMENTAL | - |
| DNL343 | EXPERIMENTAL | Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses |
| Name | Type | Description |
|---|---|---|
| [14C]-DNL343 | DRUG | Single dose |
| DNL343 | DRUG | Oral repeating dose |
| Placebo | DRUG | Oral repeating dose |
Inclusion Criteria: * Males, aged between 18 to 65 years, inclusive * Body mass index between 18.0 and 32.0 kg/m2 * In good health * When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception * History of a ...
DNL343 is an investigational small molecule being studied for Amyotrophic Lateral Sclerosis (ALS) and in healthy volunteers. It is developed by Denali Therapeutics Inc. (DNLI). As of now, DNL343 is in Phase 1 clinical development and has not been approved by regulatory authorities.
DNL343 is being developed by Denali Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DNLI. Denali is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL343 in healthy volunteers and in participants with ALS.
DNL343 is in Phase 1 clinical development. All completed trials for DNL343 are Phase 1 studies, including trials in healthy volunteers and in participants with Amyotrophic Lateral Sclerosis. DNL343 is investigational and has not received FDA approval.
DNL343 has completed three Phase 1 trials: NCT04268784 in healthy volunteers in the Netherlands, NCT04581772 in healthy volunteers in New Zealand, and NCT05006352 in participants with ALS in the United States and Netherlands. A fourth trial, NCT06281158, studied the absorption and metabolism of a radiolabeled form of DNL343 in healthy males.
DNL343 is the primary name used in clinical trials and by the developer Denali Therapeutics. No alternative names have been reported for this investigational drug. It is a small molecule being studied for ALS and in healthy volunteer studies.