Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DA-9801 · 1 trial · 1 indication
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
| Arm | Type | Description |
|---|---|---|
| DA-9801 300mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 100mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 600mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 200 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 900mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 300 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| DA-9801 300mg | DRUG | 300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks. |
| DA-9801 600mg | DRUG | 600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks. |
| DA-9801 900mg | DRUG | 900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks. |
| Placebo | DRUG | Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient. |
Inclusion Criteria: * Must be 18 to 75 years of age * Diagnosed with Type I or Type II diabetes * HbA1c ≤ 12% at the time of screening * Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequat...
DA-9801 is an investigational small molecule being developed for the treatment of diabetic neuropathy, a type of nerve damage that can occur in people with diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
The specific molecular target of DA-9801 has not been disclosed. It is a small molecule being studied for its potential to treat diabetic neuropathy, but its mechanism of action is not publicly detailed in the available information.
DA-9801 is being developed by MetaVia Inc., a biopharmaceutical company. MetaVia Inc. is publicly traded under the ticker symbol MTVA on the stock market.
DA-9801 is in Phase 2 clinical development. It has completed one Phase 2 clinical trial and is not yet approved by the FDA or other regulatory agencies. The drug remains investigational and has not been authorized for commercial use.
DA-9801 has been studied in one completed Phase 2 clinical trial, identified as NCT01822925. This trial was a randomized, double-blind, placebo-controlled study that enrolled 128 participants with diabetic neuropathy in the United States.
No alternative names for DA-9801 have been reported. It is identified solely by its developmental code name DA-9801 and is not known to be marketed under any other brand or generic name.