Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tetrodotoxin · 4 trials · 4 indications
The primary cardiodynamic endpoint was the effect of TTX plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 \& 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values.
| Arm | Type | Description |
|---|---|---|
| Tetrodotoxin | EXPERIMENTAL | There is only one arm; active treatment with TTX |
| Sugar injection | PLACEBO_COMPARATOR | - |
| Treatment Arm | EXPERIMENTAL | (Period 1) A single TTX dose of 15 μg (0.5 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) (Period 2) A single TTX dose of 30 μg (1 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) (Period 3) A single TTX dose of 45 μg (1.5 mL of TTX 30 μg/mL injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet) |
| Control | PLACEBO_COMPARATOR | Treatment D: (Period 1)A single matching-TTX placebo administered with a single oral moxifloxacin matching placebo Treatment E: (Period 2)A single matching-TTX placebo with a single oral 400 mg moxifloxacin Treatment F: (Period 3)A single matching-TTX placebo with a single oral moxifloxacin matching placebo Treatment G: (Period 1)A single matching-TTX placebo with a single oral 400 mg moxifloxacin Treatment H: (Period 2)A single matching-TTX placebo with a single oral moxifloxacin matching placebo Treatment I: (Period 3)A single matching-TTX placebo with a single oral 400 mg moxifloxacin |
| Placebo | PLACEBO_COMPARATOR | - |
| Tetrodotoxin, TTX | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tetrodotoxin | BIOLOGICAL | 30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response |
| Placebo | BIOLOGICAL | 2 mL subcutaneous injection twice daily for 4 days |
| Placebos | DRUG | matching placebo comparator |
Inclusion Criteria: All patients who participated in the TEC-006 study (tetrodotoxin and placebo-treated) will be eligible for inclusion in this study provided they wish to continue to receive treatment and meet the inclusion and exclusion criteria. NOTE: The blinded treatment assignment of patien...
Tetrodotoxin is an investigational small molecule being studied for the treatment of moderate to severe inadequately controlled cancer-related pain. It has been evaluated in clinical trials for pain associated with cancer, as well as in healthy volunteer studies, including a thorough QT (TQT) study to assess cardiovascular effects.
Tetrodotoxin is being developed by Dogwood Therapeutics, Inc., a biopharmaceutical company traded under the ticker DWTX. The company has conducted clinical trials of tetrodotoxin for cancer-related pain and healthy volunteer studies.
Tetrodotoxin is an investigational drug that has completed Phase 1, Phase 3, and other clinical trials. It is not FDA approved and remains in clinical development. The most advanced studies completed were Phase 3 trials for cancer-related pain, though the drug is not yet approved for any use.
Tetrodotoxin has been studied in several completed trials, including NCT00725114, a Phase 3 safety and efficacy study for cancer-related pain; NCT00726011, an open-label continuation study; NCT01527734, a Phase 1 formulation comparison in healthy volunteers; and NCT04083833, a Phase 1 TQT study in healthy subjects.
Tetrodotoxin is commonly abbreviated as TTX. Clinical trial records refer to the drug as tetrodotoxin (TTX), and studies have evaluated both liquid and lyophilized formulations of subcutaneous tetrodotoxin. The abbreviation TTX is used interchangeably with the full drug name in research contexts.