This section highlights FDA-related milestones and regulatory updates for drugs developed by Dogwood Therapeutics (DWTX).
Over the past two years, Dogwood Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Halneuron and HALT-CINP. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Halneuron - FDA Regulatory Timeline and Events
Halneuron is a drug developed by Dogwood Therapeutics for the following indication: In Patients with Chemotherapy-Induced Neuropathic Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Halneuron
- Announced Date:
- March 18, 2025
- Indication:
- In Patients with Chemotherapy-Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc. announces the dosing of the first patient in its Phase 2b clinical trial, referred to as HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain), evaluating Halneuron® for the treatment of neuropathic pain associated with prior chemotherapy treatment ("CINP").
AI Summary
Dogwood Therapeutics, Inc. announced that the first patient has been dosed in its Phase 2b clinical trial, HALT-CINP, which evaluates Halneuron® for treating chemotherapy-induced neuropathic pain (CINP). Halneuron® is a first-in-class, non-opioid medicine designed to inhibit the NaV 1.7 sodium channel, a key player in pain transmission. This targeted action may allow for very low doses to reduce pain effectively while minimizing off-target effects that have challenged previous NaV 1.7 inhibitors.
Previous studies have shown that Halneuron® can significantly reduce cancer-related pain and has been well-tolerated among patients, with no signs of addiction risk. The trial plans to enroll 100 patients by the fourth quarter of 2025, at which time an interim analysis will help guide any necessary adjustments to improve study outcomes, marking a promising step forward in non-opioid pain management for CINP patients.
Read Announcement
HALT-CINP - FDA Regulatory Timeline and Events
HALT-CINP is a drug developed by Dogwood Therapeutics for the following indication: Treatment of Chemotherapy Induced Neuropathic Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HALT-CINP
- Announced Date:
- January 21, 2025
- Indication:
- Treatment of Chemotherapy Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc. announced that dosing of the first patient in its Phase 2b clinical trial, referred to as HALT-CINP (Halneuron® Treatment of Chemotherapy Induced Neuropathic Pain), evaluating Halneuron® to treat neuropathic pain associated with prior chemotherapy treatment ("CINP") is expected to occur in the first quarter of 2025.
AI Summary
Dogwood Therapeutics, Inc. announced that dosing of the first patient in its Phase 2b HALT-CINP clinical trial is expected to start in the first quarter of 2025. The trial will evaluate Halneuron®, a first-in-class Nav 1.7 inhibitor designed to treat neuropathic pain caused by prior chemotherapy treatment (CINP). Halneuron® is a non-opioid option that has previously shown significant pain reduction in cancer patients during earlier Phase 2 studies, with an acceptable safety profile and no addiction concerns. This trial aims to provide an alternative treatment for the chronic and challenging neuropathic pain that many patients experience after chemotherapy. By pursuing this research, Dogwood Therapeutics is focusing on addressing a significant unmet medical need and offering hope to patients who have limited effective treatment options for managing chemotherapy-induced neuropathic pain.
Read Announcement
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