Is LTX-315 legal in the US?
No. It is not approved. A phase 2 trial has finished, and no phase 3 trial is registered.
Not approved by the FDA for any use. LTX-315 (ruxotemitide, developed by Verrica Pharmaceuticals as VP-315) is an investigational oncolytic peptide, and the FDA accepted Verrica's IND application for basal cell carcinoma in November 2021. Verrica's phase 2 basal cell carcinoma trial (NCT05188729) finished in April 2024 and posted results on ClinicalTrials.gov in June 2025; no phase 3 trial is registered.
No. It is investigational. In 2021 the FDA accepted an IND for basal cell carcinoma. That permits trials, not sales. 2
More on LTX-315
Citations
- Spicer 2021, Clin Cancer Res: Phase 1 study of intratumoral LTX-315 in advanced solid tumors pubmed.ncbi.nlm.nih.gov
- Verrica Pharmaceuticals 2021: FDA acceptance of IND application for LTX-315 in basal cell carcinoma verrica.com
- ClinicalTrials.gov: NCT05188729, VP-315 phase 2 trial in basal cell carcinoma clinicaltrials.gov
Reference information only, not medical advice. Drawn from the LTX-315 article, fact-checked against the cited sources. No dosing anywhere on this site.