Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Halneuron · 1 trial · 3 indications
Change from Baseline in the weekly average of daily 24-hour pain intensity scores analyzed by percentage of responders among patients treated with Halneuron compared to Placebo
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Halneuron | EXPERIMENTAL | Halneuron |
| Open Label Extension | ACTIVE_COMPARATOR | Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site. |
| Name | Type | Description |
|---|---|---|
| Halneuron | DRUG | Halneuron for Subcutaneous Injection |
| Placebo | DRUG | Placebo for Subcutaneous Injection |
| Halneuron (Open Label Extension) | DRUG | Halneuron for Subcutaneous Injection |
Inclusion Criteria: * Male or female patients aged ≥18 years. * Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy. * Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression...
Halneuron is an investigational small molecule being developed for the treatment of chemotherapy induced neuropathic pain, a type of nerve pain caused by cancer treatments. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Halneuron is being developed by Dogwood Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DWTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy for chemotherapy induced neuropathic pain.
Halneuron is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Fast Track designation by the FDA, which is intended to expedite the development and review process for serious conditions.
Halneuron is being studied in a Phase 2 clinical trial with the identifier NCT06848348. This trial is titled 'Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain' and is currently recruiting participants in the United States. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 240 participants.
Halneuron is the primary name for this investigational drug. No alternative names have been disclosed in the available information. It is being studied under the clinical trial identifier NCT06848348 for chemotherapy induced neuropathic pain.