Is LTX-315 FDA-approved, and what does the research show?

What is LTX-315?

LTX-315 is an investigational cancer drug ¹, ³. It is not a cosmetic, wellness, weight or performance product: the trials cited here are cancer trials ¹, ², ⁵, ⁶. It is a peptide, a short chain of amino acids, with nine of them, and it is made synthetically ¹, ³. Its trial report calls it an "oncolytic peptide," one that kills cancer cells by breaking them open ¹. It is given intratumorally, which means a clinician injects it straight into a tumor ¹, ¹⁰.

The drug grew out of research on cationic antimicrobial peptides, positively charged peptides that plants and animals use as a first defense against microbes ³. Its developers describe shortening and modifying bovine lactoferricin, a peptide from a cow's milk protein, to make stronger anticancer versions ³. They present LTX-315 as a synthetic peptide "designed for intralesional treatment of tumors" ³.

Lytix Biopharma AS is the lead sponsor on five of the seven registry records cited here ⁹, ², ⁶, ¹¹, ¹². In a release of November 18, 2021, Verrica Pharmaceuticals said it held "an exclusive worldwide license to develop and commercialize LTX-315 for dermatologic oncology indications," under an agreement with Lytix ¹⁰. One registry record also calls the drug ruxotemitide, and an early paper calls it Oncopore ², ³.

Verrica's phase 2 trial in basal cell carcinoma, a skin cancer, is registered under the code VP-315, and its record never uses the name LTX-315 ⁷. Verrica, which licensed LTX-315 from Lytix, calls VP-315 "formerly LTX-315 and VP-LTX-315" and names this trial, NCT05188729, in a May 2024 filing ⁸. The link also rests on two things. Verrica's release of November 18, 2021 said the company expected to start a phase 2 trial of LTX-315 in basal cell carcinoma in the first quarter of 2022 ¹⁰. The VP-315 record names Verrica as sponsor and gives a start date of February 1, 2022 ⁷.

Is LTX-315 FDA-approved?

LTX-315 is not FDA-approved: Drugs@FDA lists no approved LTX-315 product as of November 9, 2026 ⁴. It is an investigational cancer drug. On November 10, 2026, ClinicalTrials.gov gave one phase 2 trial of LTX-315 the status "Recruiting," in a record whose last update was posted October 26, 2024 ⁵. It gave five other LTX-315 trials the status "Completed," in records last updated between January 2012 and September 2026 ⁹, ², ⁶, ¹¹, ¹². With no approved product, LTX-315 has no FDA label, the document that sets out a drug's approved uses and warnings ⁴.

A phase 1 trial tests safety in a small group, and a phase 2 trial looks for early signs of an effect. Each of the six records cited here that name LTX-315 is one or the other ⁹, ², ⁵, ⁶, ¹¹, ¹². Verrica's trial of VP-315 is also phase 2, and its record reads "Completed," last update posted June 18, 2025 ⁷.

On November 18, 2021, Verrica said FDA "has accepted the Company's Investigational New Drug Application" for LTX-315 in basal cell carcinoma ¹⁰. An investigational new drug application, or IND, is the filing a company makes before it tests a drug in people in the United States. It is not an approval, and the acceptance is the company's own statement ¹⁰.

No source cited here shows a route to LTX-315 outside a clinical trial. FDA keeps two lists of bulk drug substances nominated for compounding, the making of a medicine by a pharmacy or an outsourcing facility. The list for pharmacies under section 503A, updated May 14, 2026, does not name LTX-315, ruxotemitide or lactoferricin ¹³. Neither does the list for outsourcing facilities under section 503B, updated March 21, 2025 ¹⁴.

See the FDA status of every peptide, updated weekly.

How does LTX-315 work?

The mechanism is proposed by the drug's developers from work in cells and mice, with early support from tumor samples taken in one human trial ³, ¹. Shown in cells: LTX-315 was "highly active against both murine and human melanoma cell lines in vitro," that is, in mouse and human cancer cells in a dish ³. The peptide carries a positive charge, and the authors say cancer cell membranes tend to carry a negative one ³. They conclude that it kills by "a direct disruptive effect of the peptide on the plasma membrane of tumor cells" ³.

Verrica's 2021 release describes the action differently, as "inducing lysis of intracellular organelles of tumor cells such as mitochondria" ¹⁰. In plain words, that is the bursting of working structures inside the cell, such as the mitochondria that supply its energy.

The second step is proposed. The burst cells spill their contents, including danger signals and tumor proteins, into the tissue around them ³. The authors call this immunogenic cell death, a kind of cell death that can provoke an immune response against the dead cells' proteins ³. They "postulate" that T cells, the immune cells that kill abnormal cells, then learn to attack the cancer cells that remain ³.

Studied in animals: in mice with B16 melanoma, a mouse melanoma grown for laboratory studies, "a majority of the animals (~80%) treated with LTX-315 experienced a complete and long-lasting tumor regression" ³. Mice whose tumors had regressed were protected when the same tumor cells were given to them again ³. All three authors of that paper disclose financial ties to Lytix Biopharma ³.

Studied in people: in the phase 1 trial of 39 patients, 12 of 14 tumor biopsies showed more CD8+ T cells inside the injected tumor after treatment ¹. CD8+ T cells are the type that kills other cells. That trial's record lists arms that add a second drug acting on the immune system, and the paper's abstract does not say which arms the biopsies came from ⁹, ¹.

What does the research show?

Each trial with results cited here is open-label, and none has a comparison group ⁹, ⁷, ², ⁶. Open-label means that patients and doctors know which treatment is given. Without a comparison group, a trial cannot show what would have happened without the drug.

Studied in people: the phase 1 trial reported by Spicer and colleagues, open-label and dose-escalating, 39 patients with advanced solid tumors, safety and tolerability as the primary objective ¹, ⁹. Dose-escalating means that later groups of patients received higher doses than earlier ones. Patients received LTX-315 injections into tumors that could be reached, and antitumor activity was a secondary objective ¹.

The trial's registry record lists four arms, and two of them add a checkpoint inhibitor, ipilimumab or pembrolizumab ⁹. A checkpoint inhibitor is a drug that releases a brake on the immune system's T cells. The paper's abstract does not say which arms the 39 patients were in, so its results may include patients who also received one of those drugs ¹, ⁹. came from; only the abstract was opened, the full paper was not; Checker confirms from the full paper]

The abstract reports that "Substantial volume reduction (≥30%) of injected tumors occurred in 29% of the patients," without the number of patients behind the percentage ¹. Measured by immune-related response criteria, a formal scoring system for tumor response, "No partial responses ... were seen" ¹. The authors also report "evidence of abscopal effect," a term for an effect on a tumor that was not injected ¹. They conclude that LTX-315 "has an acceptable safety profile, is clinically active" ¹. That is the authors' own judgment, from a trial with no comparison group ⁹.

Studied in people, as VP-315: Verrica's trial of VP-315, a phase 2, open-label, non-randomized study, 92 adults with basal cell carcinoma, safety measures as its primary outcomes ⁷. The trial ran at U.S. sites from February 2022 to April 2024, and its results were posted on June 18, 2025 ⁷. The record's analyses count 10 participants in Part 1, at rising doses, while its participant-flow table shows 12 starting Part 1 ⁷. Added across its six cohorts, Part 2 treated 82 ⁷.

Each participant had the drug injected into one or two biopsy-proven lesions ⁷. In Part 2, every lesion was then cut out 12 to 14 weeks after the first injection and examined ⁷. A secondary measure was histological clearance, in which a central skin pathologist reads the removed tissue as scar with no tumor ⁷.

In Verrica's trial of VP-315, the registry reports histological clearance in 13 of 25 first-treated lesions in the cohort named Cohort 4 Expansion ⁷. In Cohort 5 Expansion it reports 14 of 25 ⁷. In Cohorts 1, 2, 4 and 5 its counts are 5 of 6, 1 of 3, 5 of 9 and 3 of 9 first-treated lesions ⁷. Every cohort received the drug, so the trial has no untreated lesions to compare with ⁷. The record reports no comparison with surgery alone, and no follow-up of treated lesions left in place, since every Part 2 lesion was cut out ⁷.

Studied in people: ATLAS-IT-05, a phase 2, open-label, single-arm trial, 23 patients with advanced melanoma, a skin cancer, objective response as a primary measure ². Their melanoma could not be removed by surgery and had progressed on or after anti-PD-1 or anti-PD-L1 immunotherapy, a kind of checkpoint inhibitor ². LTX-315 was injected into tumors, and pembrolizumab was given into a vein ². An objective response is a complete response, all target tumors gone, or a partial response, a fall of at least 30 percent in their summed diameter ².

Of the 22 patients analyzed for response to LTX-315 with pembrolizumab, none had a complete response and 3 had a partial response ². Six had stable disease, 12 had progressive disease, and 1 could not be evaluated ². Stable disease means the tumors neither shrank nor grew enough to count as a response or as progression, and progressive disease means the cancer grew. The record's own caveat calls the findings "hypothesis generating" and cites "the single-arm design, small size, lack of a comparator arm" ². The results were posted on September 10, 2026 ².

Studied in people: a phase 2, open-label, single-center trial, 6 adults with advanced soft tissue sarcoma, a cancer of tissues such as muscle and fat ⁶. LTX-315 was injected into a tumor, which was later removed so that immune cells could be grown from it and infused back ⁶. Four participants reached the infusion step, and none of the four had an objective response ⁶.

One record gives its trial's status as "Recruiting," last update posted October 26, 2024: NeoLIPA, a phase 2, open-label, single-center study at Oslo University Hospital with Lytix as collaborator ⁵. The record gives an estimated enrollment of 27 participants with stage III or IV melanoma that can be removed by surgery ⁵. Stage III and IV are the two highest stages on the scale doctors use for how far a melanoma has spread. Under the record's plan, participants receive LTX-315 and pembrolizumab before the operation, and the record posts no results ⁵.

Two earlier phase 1 records read "Completed," last updated in February 2013 and January 2012, with actual enrollment of 14 and 12, and neither posts results ¹¹, ¹². None of the sources cited here reports a randomized trial of LTX-315, and none of the registry records lists body weight, skin aging or athletic performance as an outcome ⁹, ⁷, ², ⁵, ⁶, ¹¹, ¹².

What are the side effects?

Among treatment-related events of grade 1 to 2, mild to moderate, in the phase 1 trial of 39 patients with advanced solid tumors, the most common were "vascular disorders including transient hypotension (18 patients, 46%), flushing (11 patients, 28%), and injection site reactions in 38% of patients" ¹. Hypotension is low blood pressure. The abstract adds that "The most common grade 3 LTX-315-related toxicities were hypersensitivity or anaphylaxis (4 patients, 10%)" ¹. Anaphylaxis is a severe allergic reaction that affects the whole body, and grade 3 means severe. The trial's record lists arms that add ipilimumab or pembrolizumab, and the paper's abstract does not say which arms these patients were in ⁹, ¹.

In Verrica's trial of VP-315, in 92 adults with basal cell carcinoma, the registry records no deaths ⁷. The serious adverse events listed are atrial fibrillation (an irregular heart rhythm), influenza and pneumonia, each in 1 of 10 participants of one Part 2 cohort ⁷. That cohort's count of participants with any serious event is also 1 of 10, and the record does not say whether the events were judged related to the drug ⁷. No Part 2 participant left the study because of an adverse event ⁷. In Part 1, 1 of 10 had a dose-limiting toxicity, a side effect severe enough to stop the dose from being raised ⁷.

In several arms of Verrica's trial of VP-315, dosing continued "until the lesion is necrosed," meaning until the tumor tissue had died ⁷. Added across the registry's groups, injection site erythema, or redness, was recorded in 86 of the 92 participants ⁷. By the same addition, injection site necrosis was recorded in 74 of the 92, ulcer in 32, pain in 22, and hypotension in 4 ⁷.

In ATLAS-IT-05, the 23 patients had advanced melanoma and received pembrolizumab as well as LTX-315 ². Among the 23, the registry records 2 deaths and 11 patients with a serious adverse event, counting all causes ². The serious events listed include sepsis, pneumonia, acute kidney injury, decreased blood pressure and two deaths from progression of the cancer ². Sepsis is a life-threatening reaction of the body to an infection.

In the same trial, events that investigators judged related to LTX-315 were mostly local: of the 23 patients, 20 had injection site pain, 10 erythema and 6 swelling ². Treatment-related injection site pain of grade 3 or higher was recorded in 5 of the 23 ². The record's row calls these events "Treatment Related" and names no drug ². In the sarcoma trial of LTX-315 with a later infusion of grown immune cells, 3 of 6 participants had a serious adverse event, and none died ⁶.

In sport

LTX-315 is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ¹⁵. The names ruxotemitide and VP-315 are not on it either, and the list names no oncolytic or antimicrobial peptide class ¹⁵.

The list's section S0, on non-approved substances, reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁵. FDA is the only regulator whose records were read for LTX-315, and Drugs@FDA lists no approved product as of November 9, 2026 ⁴.

What JumpstartMD offers

JumpstartMD does not prescribe LTX-315. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.