- Evidence
- CAnimal and cell studies
- FDA status
- In clinical trialsas of 2026-10-27
- Route
- Injection
- Studies cited
- 1 human0 animal or cell
An experimental cancer drug injected straight into tumors. It has only had one early trial of 39 patients, with no comparison group.
Sold for
LTX-315 is described as a first-in-class 'oncolytic peptide' that bursts tumor cells from the inside and turns a tumor into its own vaccine, a story that outruns the single phase 1 trial published so far.
Studies say
A 39-patient uncontrolled phase 1 trial showed injected tumors regressing in some patients and immune cells moving in, which is grade C evidence until a controlled trial reports.
Why grade C. The only published human data in the citations are a phase 1 dose-escalation study of intratumoral injection in 39 patients with accessible solid tumors, uncontrolled and designed for safety. Earlier animal work established the mechanism. No randomized trial exists, so the grade is C despite the drug reaching phase 2. 1
FDA. 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.
Written from 2 cited sources. Fact-checked 2026-10-27: 12 claims checked, 2 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Treating tumors by injection
- Can a US doctor prescribe it?
- Not yet; it is still in trials.
- Properly tested in people?
- Not properly: one early safety trial of 39 patients, with no comparison group.
Evidence checklist
- Randomised controlled trial Phase 1 only, no control groupno
- Human study over 100 people 39 patients in the phase 1no
- More than one research group Developed by one companyno
- Clinical outcomes, not surrogate markers Tumor changes, not survivalno
- Human safety data beyond case reports Phase 1 safety in 39 patientsyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
LTX-315 is a lab-made peptide with nine amino acids. It comes from lactoferricin, an antimicrobial fragment of the milk protein lactoferrin. Lytix Biopharma in Norway designed it for injection straight into tumors. It is cationic and amphipathic. That means it is positively charged and part water-loving, part fat-loving. This lets it break open cell membranes. 1
In 2020, Lytix licensed LTX-315 to Verrica Pharmaceuticals for skin cancers. The FDA accepted Verrica's IND for basal cell carcinoma in November 2021. Verrica ran a phase 2 trial under the name VP-315, which its pipeline lists as completed. Lytix has separately tested the peptide with checkpoint inhibitors in melanoma and sarcoma. 2
How it works
The peptide crosses the tumor cell's outer membrane. It then attacks the membranes of structures inside the cell, especially mitochondria. The cell bursts and dies (necrosis), spilling its contents. These include tumor antigens and 'danger signals' such as ATP and HMGB1. The signals recruit and activate immune cells. The goal is that the injected tumor dies on the spot and the immune system learns to spot tumor cells elsewhere. That is why researchers are pairing it with checkpoint inhibitors. 1
What human research shows
The phase 1 study treated 39 patients with advanced solid tumors (melanoma, breast cancer, sarcoma, and others). Doctors injected accessible lesions again and again. The drug was tolerable. The most common treatment-related effects were brief low blood pressure (46% of patients), injection-site reactions (38%) and flushing (28%). Biopsies of injected tumors showed necrosis. In 12 of 14 sampled tumors, more CD8 T cells had moved in after treatment. Injected tumors shrank by at least 30% in volume in 29% of patients. But no patient met the criteria for a partial response. Shrinkage of lesions that were not injected would show an immune effect across the body. The study reported that only as isolated evidence. 1
No one has published a controlled trial. As of this writing, the basal cell carcinoma phase 2 has not reported results in a peer-reviewed form. 2
| Study | Model | Finding |
|---|---|---|
| Phase 1 intratumoral LTX-315 (Spicer 2021) | Humans, n=39 with advanced solid tumors, open-label dose escalation | Tolerable with local and transient systemic reactions; necrosis and increased CD8 T cell infiltration in injected tumors; injected tumors shrank by 30% or more in 29% of patients, with no formal partial responses. 1 |
| Verrica IND acceptance for basal cell carcinoma | Regulatory announcement, 2021 | FDA accepted the IND, allowing a phase 2 trial in basal cell carcinoma to start in 2022. 2 |
Safety
In the phase 1 trial, the main adverse events were local pain and inflammation at the injection site. Short-lived reactions in the body (flushing, low blood pressure, fever) followed soon after injection. These fit the release of cell contents and histamine. The most common grade 3 events were hypersensitivity or anaphylaxis, in 4 of 39 patients (10%). 1
The published literature covers only 39 treated patients. So the full side-effect profile is unknown. Anything sold online as LTX-315 for self-injection has no clinical basis. 1
Questions for your clinician
- Is LTX-315 available outside a clinical trial?
- What did the phase 1 study show about tumor response?
- What serious reactions occurred after injection?
Questions people ask
Is LTX-315 FDA-approved?
No. It is investigational. In 2021 the FDA accepted an IND for basal cell carcinoma. That permits trials, not sales. 2
How does an oncolytic peptide differ from chemotherapy?
Chemotherapy travels through the body and damages dividing cells. LTX-315 is injected straight into a tumor. There it breaks open cell membranes and releases tumor contents, which can prompt an immune response. 1
Did it shrink tumors in people?
Some injected lesions shrank in the 39-patient phase 1 trial. Biopsies showed immune cells moving in. Tumors that were not injected rarely shrank. The trial had no control group. 1
What reactions follow an injection?
Pain and swelling at the injection site. Some patients had brief flushing, fever or low blood pressure after injection. A small number had more severe reactions. 1
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