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 developed by Dogwood Therapeutics, Inc. (DWTX) for the treatment of moderate to severe inadequately controlled cancer-related pain. It is administered subcutaneously and has been studied in clinical trials for pain management in cancer patients.
Tetrodotoxin is a small molecule that works by blocking sodium channels, specifically the voltage-gated sodium channels responsible for pain signal transmission. By inhibiting these channels, it aims to reduce pain signaling in patients with cancer-related pain.
Tetrodotoxin is being developed by Dogwood Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol DWTX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for pain management.
Tetrodotoxin is currently in Phase 1 clinical development. While it has completed Phase 3 trials for cancer-related pain, the most recent studies are Phase 1 trials evaluating its cardiovascular effects and formulation comparisons in healthy volunteers. It remains investigational and is not FDA approved.
Tetrodotoxin has completed four clinical trials. These include two Phase 3 studies (NCT00725114 and NCT00726011) for cancer-related pain, and two Phase 1 studies (NCT01527734 and NCT04083833) in healthy volunteers. The Phase 1 trials evaluated formulation differences and cardiovascular effects, including a TQT study.
Yes, Tetrodotoxin is commonly referred to as TTX. In clinical trials, it is often identified by this abbreviation, such as in the study titled 'Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers.'