Hoth Therapeutics ends Phase 2a of skin-toxicity drug HT-001 early on strong efficacy, plans Phase 3

What's the deal? Hoth TherapeuticsDealroom has a profile for this one. Try Dealroom →, a New Jersey-based biopharmaceutical company, has decided to end its Phase 2a clinical trial of HT-001 early following strong interim efficacy results, and is preparing to seek FDA feedback on advancing the drug into a potential Phase 3 programme. The company announced the decision on 3 November 2026.

Why it matters: HT-001 is an investigational topical formulation of aprepitant, an existing medicine, being developed to treat the skin toxicities — rash and related side effects — that commonly affect cancer patients treated with EGFR inhibitors, a widely used class of targeted cancer drugs. These skin reactions are a leading reason patients reduce or halt their cancer treatment, so an effective topical therapy could help people stay on their oncology therapy. Hoth determined that the interim efficacy and safety data support concluding Phase 2a early and moving toward regulatory discussions on the next stage of development.

Next steps: the company plans to request FDA feedback on the design of a potential pivotal study, including efficacy endpoints, patient population, statistical considerations, safety requirements and manufacturing readiness. Initiation of a Phase 3 trial will depend on that regulatory feedback and completion of the remaining data analysis; interim results are preliminary and may change as the data are finalised.

Read more: Hoth Therapeutics press release via BioSpace, Nov 2026