Ruxotemitide (LTX-315, VP-315)_Dosage, benefits & legal status
Four development names for one molecule. The FDA substance registry lists LTX-315 and the brand name Oncopore against the INN ruxotemitide; VP-315 and VP-LTX-315 come from the licensee's own filings, stating in plain terms that VP-315 is ruxotemitide, formerly LTX-315 and VP-LTX-315. The melanoma trial registry record still uses only LTX-315 and contains neither of the newer names.
Nine residues, eight of them lysine or tryptophan, injected straight into a tumor.
What is Ruxotemitide (LTX-315, VP-315)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is an experimental cancer drug, not a peptide anyone can buy, and it works in a way that has nothing in common with the metabolic and cosmetic peptides on the rest of this site. A doctor injects it straight into a tumor, where it ruptures the cancer cells. The theory is that the wreckage left behind acts as an alarm signal, waking up an immune system that had been ignoring the tumor, so that immune cells attack cancer elsewhere in the body too. The chemistry is unusually simple: nine building blocks, and only three different kinds among them, five lysines and three tryptophans plus one engineered residue. It carries four different names in circulation, and that is the main reason to have a page for it. The same molecule is ruxotemitide, LTX-315, VP-315 and VP-LTX-315, depending on which company is talking. On the results: its melanoma trial announced success in November 2026 and the actual number is under embargo until December 15. The only figure anyone can check is from an interim analysis a year earlier, where four of the first nine patients assessed had no viable tumor left. Everyone in that trial also received pembrolizumab, a standard immunotherapy that produces complete responses on its own, and the trial had no comparison group.
Ruxotemitide is a synthetic nine-residue oncolytic peptide injected directly into tumors, developed by Lytix Biopharma and licensed to Verrica Pharmaceuticals for certain skin cancers. Eight of its nine residues are lysine or tryptophan, the composition signature of the host-defense peptide family its developer builds from. Rather than binding a receptor, it lyses tumor cell membranes, and the stated mechanism is that the debris released turns an immunologically cold tumor into an immune-activated one. It is approved nowhere. Its phase 2 trial in resectable melanoma, given with pembrolizumab before surgery, announced on November 3, 2026 that it had met its primary endpoint of pathological complete response, but the figure itself is embargoed until a conference presentation on December 15, 2026. The only response number in public is a year-old interim: four of the first nine evaluable patients.
What it's used for
Under investigation in resectable stage III to IV melanoma, given with pembrolizumab before surgery, and in basal cell carcinoma and squamous cell carcinoma under a separate licensee. A study in Gorlin syndrome, a genetic condition that produces repeated basal cell carcinomas, is being designed. None of these is an approved use.
How does Ruxotemitide (LTX-315, VP-315) work?
What it does in the body, and where.Most peptides on this site work by fitting a receptor. This one works by tearing a hole in a membrane, and the immune consequences of that are the actual therapeutic claim.
- 01Eight of nine residues are lysine or tryptophanFive lysines carry positive charge that pulls the peptide onto a negatively charged tumor cell surface. Three tryptophans are bulky and greasy and bury themselves in the membrane. That is the whole design.
- 02The membrane fails and the cell diesInjected directly into a tumor, the peptide lyses cancer cells rather than signaling to them. The developer's term for the result is immunogenic cell death.
- 03Spilled contents act as an alarmTumor antigens and cellular debris are released where immune cells can find them. Data presented at an immunotherapy meeting in 2025 described the tumor microenvironment shifting from immune-suppressed to immune-activated.
- 04The hoped-for effect is at a distanceIf the immune system learns the tumor, untreated lesions should shrink too. The licensee reports exactly that in the basal cell carcinoma study and calls it a possible effect beyond the injection site. It remains an observation in an uncontrolled study.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
The molecule, checked by rebuilding it
Research only- Lab studyNine residues, KKWWKKW then a diphenylalanine then a lysinamide. Five of the nine are lysine and three are tryptophan, so eight of nine positions are one of two amino acids. Positive charge finds the tumor cell surface, bulk and greasiness get into the membrane.
- Lab studyRebuilding the molecular formula from that reading gives C78H106N18O9 and an average mass of 1439.82, against C78H106N18O9 and 1439.79 in the registry. An exact formula match on carbon, hydrogen, nitrogen and oxygen is strong confirmation that the nine-residue reading is right.
- No dataA validation note on the same registry record states the sequence as KKWWKKWXKX. That string has ten positions and contradicts both the chemical name and the formula on the record it sits on. Anyone taking the sequence from that line alone would get the molecule wrong.
- RegulatoryFour names for one molecule, and that is the most practical reason this page exists. The FDA registry carries LTX-315 and the brand name Oncopore under the INN ruxotemitide. The licensee's own quarterly filing states that VP-315 is ruxotemitide, formerly LTX-315 and VP-LTX-315. The melanoma trial registry uses only LTX-315 and contains neither newer name.
The melanoma trial, and why its famous number is not its result
Investigational- Human trialNeoLIPA is a single-arm, open-label phase 2 at one hospital, Oslo University Hospital, with the developer as industry collaborator and 27 participants estimated. Ruxotemitide goes intratumorally once weekly for up to five dosing days; pembrolizumab goes in at 200 mg every three weeks for up to 18 doses, three of them before surgery.
- Human trialThe primary endpoint is pathological complete response in the treated tumor bed at 12 weeks. It is a local endpoint, on a lesion that had to be 3.0 cm or smaller to be injected in the first place.
- RegulatoryNovember 3, 2026: the endpoint was met, the rate in the evaluable population to date cleared the prespecified 40% criterion, and the exact rate for the complete evaluable population was explicitly not disclosed. November 9: the abstract was accepted for a late-breaking oral presentation. November 13: the quarterly report confirmed all patients enrolled. Three announcements in ten days, no number in any of them.
- Human trialThe only checkable response data is the interim of November 11, 2025: pathological complete response in 44% of the first nine evaluable patients, four people, out of 13 then enrolled, with 88% overall pathological response, 55% major pathological response and no relapses reported at that point.
- No dataThe benchmark is where the result will be won or lost. The protocol requires the lower bound of the 95% confidence interval to exceed a historical pathological complete response rate for pembrolizumab alone, reported as 20%. An equity research note on the same trial puts historical controls at 20% to 27%. Against 20% a 40% result is convincing; against 27% it is thinner, and no randomized data exists either way.
- No dataThe registry record was last updated October 26, 2024, lists the study as recruiting, and gives an estimated primary completion of May 2026. All three are now out of date, worth knowing for anyone who checks the registry rather than the announcements.
- RegulatoryA randomized phase 3 is planned, comparing ruxotemitide plus pembrolizumab against pembrolizumab alone with event-free survival as the primary endpoint. That is the trial that would answer the question this phase 2 cannot. The developer reports the FDA raised no objection to the design.
The skin cancer program, under a different company
Investigational- Human trialA completed multicenter open-label phase 2 proof-of-concept study in basal cell carcinoma, run by the licensee as protocol VP-315-201, reported a 97% objective response rate, an average 86% reduction in treated tumor size, and complete histologic clearance in 51%.
- No dataBoth sponsors describe that 97% as a calculated objective response rate. Set beside 51% complete histologic clearance from the same study, the honest reading is that nearly every treated lesion got smaller and about half were cleared.
- human-earlyLesions that were not injected also shrank, and the licensee offers that as evidence of an effect beyond the injection site. Immune response data presented at an immunotherapy meeting in November 2025 described all non-treated lesions studied reducing in size. The study was uncontrolled, so this is an observation rather than a demonstrated systemic effect.
- RegulatoryThe licensee is now designing a proof-of-concept study in Gorlin syndrome, a genetic condition it puts at roughly 11,000 US patients who face repeated surgery for basal cell carcinomas and for whom no therapy is approved. Patients with Gorlin syndrome were excluded from the sporadic basal cell carcinoma study the plan is built on.
- No dataThe two public accounts of the license disagree on its scope. The licensee's own quarterly filing says its worldwide rights cover certain dermatologic oncology indications including non-metastatic melanoma and non-metastatic Merkel cell carcinoma. An equity research note says the license covers dermatological cancers except melanoma and Merkel cell carcinoma. The company filing is the stronger source, and the two can be reconciled if the licensee holds the non-metastatic forms while the developer keeps advanced melanoma, the disease its own trial treats. That reconciliation is a reading, not something either source states.
What is funding this, and what comes next
Investigational- RegulatoryFull melanoma results are due on December 15, 2026, between 11:40 and 11:50, in a late-breaking oral presentation at an immuno-oncology congress in London running December 14 to 16. The chief medical officer has said the company cannot comment on the full results because the data are under embargo.
- Human trialALETTA, an investigator-initiated phase 2 planned for early 2027, would test the peptide with ipilimumab and nivolumab instead of pembrolizumab and would be the first randomized controlled data on the molecule.
- RegulatoryNeither company is well funded for what it is proposing. The developer reported a third-quarter 2026 loss of NOK 26.1 million and cash burn of NOK 24.1 million, with cash into the second quarter of 2027. Its shares fell 8.4% on the quarterly update that confirmed the trial had succeeded.
- RegulatoryThe licensee held $14.4 million in cash at the end of September 2026 against a quarterly net loss of $12.4 million, with third-quarter research spending of $7.6 million against $2.2 million a year earlier, and states that its runway excludes the cost of the Gorlin syndrome trial it is designing.
- ReviewThe developer positions the molecule against an individualized mRNA cancer vaccine in the same neoadjuvant melanoma setting, on the grounds that an off-the-shelf peptide needs no patient-specific manufacturing. That is a manufacturing argument rather than a clinical comparison, and no trial has compared the two.
The 44% pathological complete response rate. It is four patients out of nine, from an interim analysis in November 2025, and it is not the trial's result. The trial announced in November 2026 that it had met its endpoint without saying what the rate was, and the number is under embargo until December 15, 2026. The second thing dropped from most summaries is pembrolizumab. Every participant received it, three doses before surgery, in a single-arm trial with no comparison group, so none of the response figures belongs to the peptide alone. The third is the 97% in basal cell carcinoma. The sponsors themselves qualify that as a calculated objective response rate, and it sits beside complete histologic clearance of 51% in the same study. The names mislead in both directions too: ruxotemitide, LTX-315, VP-315 and VP-LTX-315 are one molecule, while the two companies using those names are running different trials in different cancers under a license that splits the indications between them.
The published record
Papers about Ruxotemitide (LTX-315, VP-315) · this compound only
Searched: ruxotemitide, LTX-315, LTX 315, VP-315, VP-LTX-315, Oncopore.
44 papers tagged human · 31 not reviews or lab · 2 clinical trial publications
How the compound was given: 7 applied to skin · 12 injected · 47 route not stated in the abstract
Read from each paper's indexing terms and abstract, by rule. A paper that mentions a cream studied a cream, not necessarily the product being sold.
7 registered trials · 3 with posted results
Furthest stage reached: Phase 2, results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. A preprint and its journal version count once. 63 papers and 7 trials held here.
At a glance
Four things to know about Ruxotemitide (LTX-315, VP-315)
Evidence
Investigational
Category
Immune support
Common vial
Varies
Half-life
Not published, and not the relevant measure for an intratumoral injection
How much, and do you cycle it?
The range, and whether you take breaks.Not published; weekly intratumoral injection on up to 5 dosing days, once weekly for up to five doses, before surgery. Up to five weekly doses before surgery, not an ongoing course Trial dose
In the melanoma setting the whole point is to treat for twelve weeks and then remove the tumor, so the schedule ends at surgery. There is nothing to cycle.
Not published, and not the relevant measure for an intratumoral injectionNo figure
No half-life figure has been published. The drug is injected into a tumor rather than into the circulation, and the licensee's phase 2 protocol lists pharmacokinetics among its objectives, so data exist and have not been released.
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Nothing to store: it is not sold anywhere.
Ruxotemitide (LTX-315, VP-315) has never been marketed, so there is no vial, pen or bottle to keep at home. Supplies for a trial are made, stored and dispensed by the sponsor and the trial pharmacy under conditions set in the protocol. Anything offered for sale under this name did not come from that supply chain.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 78% charged residues, 44% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Any use outside a clinical trial: this is injected into a tumor by a physician and is approved nowhere
- Reading the melanoma result as the peptide's own effect, when every patient in that trial also received pembrolizumab and there was no comparison group
- Treating the 44% figure as the trial's result, when it comes from an interim analysis of the first nine evaluable patients and the final figure has not been released
Stop and get help
- Not applicable outside a trial, where the protocol and the treating oncologist govern every decision
Common effects
- Not characterized in public for either program
- Shrinkage of the injected lesion, the directly observed effect in both the melanoma and the skin cancer studies
- Reported shrinkage of lesions that were not injected, described by the licensee as a possible effect beyond the injection site
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Ruxotemitide (LTX-315, VP-315) approved?
And where the numbers on this page come from.No. Ruxotemitide (LTX-315, VP-315) is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteInjected directly into a tumor, in a hospital, inside a trial
- Checked13 November 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA Global Substance Registration System record for ruxotemitide, UNII 75FBL12IZ7, with the chemical name, formula and listed namesClinicalTrials.gov NeoLIPA phase 2 record NCT06651151Lytix Biopharma announcement that NeoLIPA met its primary endpoint, November 3, 2026Lytix Biopharma announcement of the late-breaking oral presentation at ESMO Immuno-Oncology, November 9, 2026Lytix Biopharma third quarter 2026 report, November 13, 2026Lytix Biopharma interim NeoLIPA data announcement, November 11, 2025Report of the November 3 announcement giving the 20% historical pembrolizumab benchmark and the confidence-interval criterionRedeye equity research note on the NeoLIPA interim, giving historical controls as 20% to 27% and the license scopeVerrica Pharmaceuticals third quarter 2026 results, naming VP-315 as ruxotemitide, formerly LTX-315 and VP-LTX-315Verrica Pharmaceuticals third quarter 2026 earnings call summary, with the basal cell carcinoma figures and the Gorlin syndrome planClinicalTrials.gov basal cell carcinoma phase 2 record NCT05188729Verrica Pharmaceuticals phase 2 protocol VP-315-201, hosted by ClinicalTrials.govReport of the immune response data presented at the Society for Immunotherapy of Cancer annual meeting, November 2025Report of the planned ALETTA investigator-initiated study and the interim melanoma data
What has happened recently
Approved in no country. Ruxotemitide is the INN, number 10848, with CAS 1345407-05-7 and FDA substance identifier 75FBL12IZ7. The melanoma trial is NCT06651151, study 2023_16, sponsored by Oslo University Hospital with the developer as an industry collaborator, phase 2, 27 participants estimated, at a single site in Oslo. The registry record was last updated October 26, 2024 and still lists the study as recruiting, two years before the sponsor announced that enrollment was complete and the endpoint met. The planned phase 3 would randomize ruxotemitide plus pembrolizumab against pembrolizumab alone with event-free survival as the primary endpoint, and the developer reports that the FDA raised no objection to that design. That is the company's characterization of a regulatory interaction rather than any form of approval. Dermatologic rights sit with a separate licensee under a worldwide agreement; the two public descriptions of its scope disagree, and the note under research findings sets out how.
You can compare this against the whole library, or read how to check a seller.
What else is like Ruxotemitide (LTX-315, VP-315)?
Others in Immune support, side by side.If you're weighing Ruxotemitide (LTX-315, VP-315), it's worth reading Splenopentin, Surotomycin, and Teixobactin in the same class.
Nine residues, eight of them lysine or tryptophan, injected straight into a tumor.
- Dose
- Not published; weekly intratumoral injection on up to 5 dosing days
- How often
- Once weekly for up to five doses, before surgery
A five-amino-acid spleen peptide, sold on an evidence base almost nobody has read.
- Dose
- Research only
- How often
- Not established
A worked example of why one trial never settles anything.
- Dose
- 500 mg a day in trials
- How often
- Twice daily for 10 days, in trials
A decade-long lesson in what 'no resistance detected' actually means.
- Dose
- No human dose exists
- How often
- Not applicable
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA Global Substance Registration System record for ruxotemitide, UNII 75FBL12IZ7, with the chemical name, formula and listed names
- ClinicalTrials.gov NeoLIPA phase 2 record NCT06651151
- Lytix Biopharma announcement that NeoLIPA met its primary endpoint, November 3, 2026
- Lytix Biopharma announcement of the late-breaking oral presentation at ESMO Immuno-Oncology, November 9, 2026
- Lytix Biopharma third quarter 2026 report, November 13, 2026
- Lytix Biopharma interim NeoLIPA data announcement, November 11, 2025
- Report of the November 3 announcement giving the 20% historical pembrolizumab benchmark and the confidence-interval criterion
- Redeye equity research note on the NeoLIPA interim, giving historical controls as 20% to 27% and the license scope
- Verrica Pharmaceuticals third quarter 2026 results, naming VP-315 as ruxotemitide, formerly LTX-315 and VP-LTX-315
- Verrica Pharmaceuticals third quarter 2026 earnings call summary, with the basal cell carcinoma figures and the Gorlin syndrome plan
- ClinicalTrials.gov basal cell carcinoma phase 2 record NCT05188729
- Verrica Pharmaceuticals phase 2 protocol VP-315-201, hosted by ClinicalTrials.gov
- Report of the immune response data presented at the Society for Immunotherapy of Cancer annual meeting, November 2025
- Report of the planned ALETTA investigator-initiated study and the interim melanoma data
Beyond these, 70 records are indexed for this compound. Browse the records