Dogwood Therapeutics Secures FDA IND Approval For SP16 in Neuropathy Treatment

Dogwood Therapeutics has announced that the U.S. Food and Drug Administration has accepted an Investigational New Drug (IND) application for SP16, an intravenous therapy under development for chemotherapy-induced pain and peripheral neuropathy (CIPPN). This regulatory milestone enables the initiation of clinical studies to evaluate the drug’s safety and efficacy.

SP16 is designed with a dual mechanism of action that targets inflammation and tissue repair. It is believed to reduce inflammatory markers such as IL-6, IL-8, IL-1β, and TNF-alpha, while also promoting cellular repair processes through pathways involving pAKT and pERK. These combined effects could address the underlying causes of nerve damage and pain associated with CIPPN.

“FDA acceptance of our SP16 IND filing represents an important step in expanding our pipeline as we advance a second development candidate into the clinic to treat chemotherapy-induced neuropathy and pain,” said Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics. “SP16 compliments our lead candidate, Halneuron®, by not only targeting neuropathic pain but also addressing additional debilitating symptoms of neurotoxic chemotherapy, including numbness, tingling and impaired motor function.”

The company, along with its partner Serpin Pharma, plans to begin patient enrollment for a Phase 1b clinical trial in mid-2026. The study will be fully funded by a $2.5 million grant awarded to Serpin Pharma by the National Cancer Institute, which will support early-stage development of the therapy.

CIPPN remains a significant unmet need, affecting an estimated 30–40% of patients months after chemotherapy, often leading to long-term symptoms such as pain, numbness, and tingling. Dogwood previously secured a global, royalty-free license for SP16 in 2025, positioning the company to advance this non-opioid treatment option for cancer-related neuropathy.