Skin & aging Oncolytic peptide
LTX-315
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- the Investigational Oncolytic Peptide
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
LTX-315 is an investigational "oncolytic" peptide that is injected directly into tumors to break tumor cells apart and provoke an immune response, developed by Lytix Biopharma. In an early-phase trial it shrank injected tumors and triggered immune cell infiltration, and the company has described plans toward a registrational trial in melanoma. As of 2026, it is not approved and its efficacy has not been tested in controlled trials.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA
- What it is
- Oncolytic peptide injected directly into tumors (intratumorally)
- Research
- Early-phase human data show injected-tumor shrinkage and immune activation
- Controlled trials
- No controlled (randomized) efficacy data yet
- Evidence strength
- Moderate research
Summary
LTX-315 is an investigational peptide injected into tumors to trigger an immune response. See how it works, trial findings, and why it is not approved.
What is LTX-315?
LTX-315 (also known as oncopore and ruxotemitide) is an experimental peptide of nine amino acids that is injected directly into a tumor to destroy tumor cells and stimulate the immune system. It is developed by Lytix Biopharma and studied alone and in combination with immunotherapy for solid tumors such as melanoma. It is investigational and not approved.
How does it work?
LTX-315 inserts into and disrupts cell membranes, causing tumor cells to rupture in a way that releases tumor antigens and "danger signals." This form of cell death is intended to alert the immune system, drawing in cancer-fighting T-cells and potentially producing responses even in tumors that were not injected (an "abscopal" effect). The approach is being combined with immune-checkpoint drugs on the theory that releasing tumor antigens makes the immune response stronger. This describes the proposed mechanism, separate from the outcomes below.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA
Category: In clinical trials · Primary body area: Skin & aging
No. LTX-315 is investigational and not approved. Its two development programs sit at different stages:
| Program | Developer | Indication | Regulatory stage |
|---|---|---|---|
| LTX-315 | Lytix Biopharma | High-risk resectable melanoma | According to the company, FDA feedback supports a path toward a registrational Phase 3 trial, but no such trial has been completed |
| VP-315 (licensed LTX-315) | Verrica Pharmaceuticals | Basal cell carcinoma | The FDA accepted the investigational new drug (IND) application for that program in 2021, which is clearance to begin a Phase 2 clinical trial, not a marketing approval |
What does the research show?
Editor’s note
Evidence strength: Moderate research
There is real but limited positive human evidence from an early-phase, uncontrolled trial, with no randomized efficacy data and later results resting partly on company reports.
The human evidence is early-phase and uncontrolled. According to PubMed, a Phase 1 dose-ranging trial in advanced solid tumors reported:
- Tumor necrosis
- Infiltration of cancer-fighting T-cells
- At least 30% shrinkage of injected tumors in some patients
- Signs of a systemic immune response
However, standard objective responses to the drug alone were not seen.
Later Phase 2 and combination data have been reported mainly via company releases. There are no controlled efficacy trials yet, so the benefit is suggested but not established.
Sources: the Phase 1 dose-ranging trial of LTX-315 (Spicer et al., Clinical Cancer Research, 2021, DOI: 10.1158/1078-0432.CCR-20-3435), indexed on PubMed; and Lytix Biopharma development updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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