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.
Select a button below to view the list of FDA events for that drug.
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:
- May 18, 2026
- Indication:
- In Patients with Chemotherapy-Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, announced commencement of a new Halneuron® chemotherapy induced neuropathic pain ("CINP") phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron® 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a Halneuron® 12-week follow-on open-label extension study for patients completing the 4-week double-blinded treatment period.
AI Summary
Dogwood Therapeutics has started a new 12-week open-label extension study of Halneuron® for chemotherapy-induced neuropathic pain (CINP). Patients who finish the current 4-week Phase 2b study can now join the follow-on trial, which will look at whether Halneuron® continues to reduce pain over three months of treatment.
The company said the study will also collect more safety data. These results are meant to support a planned end-of-Phase-2 submission package. Dogwood noted that the new study builds on a positive interim review showing a treatment effect for Halneuron® compared with placebo during the initial 4-week blinded phase.
Dogwood Therapeutics is a development-stage biopharmaceutical company focused on treatments for pain and neuropathic disorders.
Read Announcement- Drug:
- Halneuron
- Announced Date:
- December 22, 2025
- Indication:
- In Patients with Chemotherapy-Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc. announces positive results from an interim analysis of 97 patients who had completed treatment in the ongoing Halneuron® Phase 2b chemotherapy induced neuropathic pain ("CINP") study.
AI Summary
Dogwood Therapeutics reported positive interim results from 97 patients who completed treatment in its Halneuron® Phase 2b study for chemotherapy‑induced neuropathic pain (CINP). An independent statistical review committee looked at unblinded data and concluded that patients receiving Halneuron® showed separation from placebo on pain improvement over the four‑week study. Current enrollment trends give the trial an estimated 80–85% statistical power, and the company expects top‑line results in Q3 2026. The overall study dropout rate was about 4.4%, much lower than typically seen with other chronic pain medicines, and safety and tolerability remain encouraging in this blinded analysis.
The interim group had an average CINP duration of five years, and 67% were on stable doses of other chronic pain drugs such as pregabalin, gabapentin, duloxetine, or opioids. Halneuron® is a non‑opioid NaV1.7 inhibitor, and positive Phase 2b trends could support advancement to a Phase 3 program for this unmet need.
Read Announcement- 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:
- February 2, 2026
- Indication:
- Treatment of Chemotherapy Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc. announced it has achieved over 50% of the planned enrollment in its ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain ("HALT-CINP") trial.
AI Summary
Dogwood Therapeutics announced it has enrolled more than 50% of the planned participants in its HAL-CINP-203 Phase 2b trial (HALT-CINP) testing Halneuron® for chemotherapy-induced neuropathic pain. Among the first 116 patients who completed the study, the early termination rate was low (4.3%), which suggests Halneuron® is generally well tolerated. The trial is randomized and compares Halneuron® to placebo to evaluate safety and pain outcomes in cancer patients with chemotherapy-induced neuropathy.
The study is designed to provide approximately greater than 80% statistical power to detect a treatment difference versus placebo at unblinding, which is planned for the third quarter of 2026. The trial is registered as NCT06848348. Dogwood says surpassing the halfway enrollment mark moves the program closer to a robust readout and final analysis. For more information, visit www.dwtx.com.
Read Announcement- Drug:
- HALT-CINP
- Announced Date:
- November 11, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- Treatment of Chemotherapy Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc announced that HALT-CINP remains on track to conduct a prespecified interim analysis during the fourth quarter of 2025 on patients who have completed or been terminated from the four-week study.
AI Summary
Dogwood Therapeutics reported enrollment of the first 100 patients in its HALT-CINP Phase 2b trial and said the study remains on track to run a prespecified interim analysis in the fourth quarter of 2025. That analysis will include patients who have completed or been terminated from the four-week study and is intended to assess whether the current sample size is adequate. The company is continuing with its original 200-patient plan while reserving the option to adjust enrollment based on interim findings. Final study data are expected by mid-2026.
Early trial conduct has shown a low early termination rate among the first 80 completers, which suggests Halneuron and placebo have been generally well tolerated. The trial compares Halneuron to placebo, with dosing over 14 days and safety and effectiveness followed through 28 days, and will use the change in weekly average 24-hour pain scores at week four as the primary endpoint.
Read Announcement- Drug:
- HALT-CINP
- Announced Date:
- November 11, 2025
- Indication:
- Treatment of Chemotherapy Induced Neuropathic Pain
Announcement
Dogwood Therapeutics, Inc announced it has successfully enrolled the first 100 patients in its ongoing HALT-CINP Phase 2b CINP trial.
AI Summary
Dogwood Therapeutics announced it has successfully enrolled the first 100 patients in the ongoing HALT-CINP Phase 2b trial testing Halneuron® for chemotherapy-induced neuropathic pain. Early data show a continued low early termination rate among the first 80 study completers, suggesting both Halneuron and placebo have been well tolerated. Strong patient interest and positive word of mouth helped speed recruitment. The study remains on track for a prespecified interim analysis in the fourth quarter of 2025 to review patients who have completed or been terminated from the four-week study and to assess whether the planned sample size needs adjustment. The company is continuing with the original 200-patient target and expects final data by mid-2026.
HALT-CINP is a randomized Phase 2b trial at about 25 U.S. sites comparing eight subcutaneous doses of Halneuron or placebo over 14 days, with 28 days of follow-up. The primary endpoint is change from baseline to week four in average daily 24-hour pain scores; secondary measures include sleep, fatigue, neuropathy symptoms, and overall health.
Read Announcement- 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
