ST316_Dosage, benefits & legal status
Also known as ST-316
A cell-penetrating peptide aimed at a different beta-catenin contact from zolucatetide. Phase 1/2, with responses in 7 of 15 colorectal cancer patients on chemotherapy and bevacizumab.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is ST316?
Plain language first. The technical label stays, but it never stands alone.Overview
Overactive beta-catenin drives most colorectal cancers and the polyps of familial adenomatous polyposis (FAP). In 23 patients with advanced cancers, weekly ST316 caused no dose-limiting side effects and some long-lasting stable disease. Added to FOLFIRI chemotherapy and bevacizumab in 15 people with colorectal cancer already treated once, 7 had a confirmed response, against a historical rate of about 11% that the company cites. No trial has a control group yet.
ST316 is a cell-penetrating peptide that binds the first armadillo repeat of beta-catenin, the site its co-activators BCL9 and BCL9L use, so beta-catenin cannot switch on its cancer-driving Wnt genes. Its sequence, length and chemistry are undisclosed; a Sapience patent application on modified BCL9 mimetic peptides, based on the 24-residue BCL9 helix that grips beta-catenin, probably covers it but does not name it. Sapience Therapeutics, a private company in Tarrytown, New York, develops it.
What it's used for
An experimental intravenous drug in a phase 1/2 trial for colorectal cancer, with a phase 1b study in FAP due to start in January 2027. Not available outside trials.
How does ST316 work?
What it does in the body, and where.ST316 blocks one of the partners beta-catenin needs to switch on cancer genes.
- 01The build-upWhen APC is lost or the beta-catenin gene is mutated, beta-catenin accumulates in the cell, as in most colorectal cancers and in FAP.
- 02The co-activatorTo switch on its cancer-driving genes, beta-catenin recruits BCL9 or BCL9L to help assemble the gene-activating complex on DNA.
- 03Blocking the dockST316 carries a cell-penetrating segment, then binds beta-catenin's first armadillo repeat, where BCL9 docks. The company says no other partner uses this site, so normal Wnt signalling in gut and bone should continue. No binding figures have been published.
- 04Effects seen so farIn phase 1 biopsies, beta-catenin moved out of the nucleus in 4 of 7 patients, and immune-suppressing myeloid cells (PMN-MDSCs) fell in all 7 patients who started with high levels.
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.
Phase 1, advanced cancers
Investigational- Human trial23 patients given 0.5 to 12 mg/kg weekly: prolonged stable disease, with no objective responses reported.
- human-earlyBeta-catenin moved out of the nucleus in 4 of 7 biopsied patients, a sign the drug reached its target.
Phase 2, colorectal cancer
Investigational- Human trialWith FOLFIRI and bevacizumab: 7 of 15 confirmed partial responses and 14 of 15 with disease control.
- No dataThe comparison is with historical figures the company chose, quoted as 5 to 23% in April 2026 and 11% in September 2026.
ST316 and zolucatetide are different molecules hitting different contacts on beta-catenin: ST316 blocks BCL9 and BCL9L, zolucatetide blocks TCF/LEF. ST316 is dosed in mg/kg weekly, zolucatetide in mg/m2. ST316 has no INN, so any generic-sounding name for it is invented. The September 2026 FAP news was an IND acceptance, not a trial result; the FAP orphan designation dates from December 2024, and no FAP patient has been treated. The 47% response rate comes from 15 patients on chemotherapy and bevacizumab, compared with historical figures the company chose. The registry lists the trial as phase 1 while its title and the company call the expansion phase 2. One report's tumour-type breakdown of the 23 phase 1 patients adds up to 22.
The published record
Papers and trials about ST316
2 papers tagged human · 0 not reviews or lab · 0 clinical trial publications
2 registered trials · none with posted results
Furthest stage reached: Phase 1, under way
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.
At a glance
Four things to know about ST316
Evidence
Investigational
Category
Longevity and energy
Common vial
Varies
Half-life
Not published
How much, and do you cycle it?
The range, and whether you take breaks.0.5 to 12 mg/kg weekly in dose-finding (trial), once weekly (every three weeks is also being tested in fap). Weekly until the cancer progresses Trial dose
Given every week, alongside chemotherapy cycles in phase 2, for as long as the cancer is controlled.
Not publishedNo figure
Phase 1 showed exposure rising in proportion to dose and reaching the levels predicted to work. Half-life, peak and clearance are trial endpoints but have not been published.
Source: Sapience Therapeutics, AACR 2026 release (qualitative only)
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Phase 1 tested 0.5, 1, 2, 4, 8 and 12 mg/kg as a weekly intravenous infusion, in six cohorts. The dose used in the phase 2 colorectal cancer groups has not been published, and no maximum tolerated dose was reached. Phase 2 partner drugs: FOLFIRI with bevacizumab, fruquintinib, or trifluridine/tipiracil with bevacizumab. The planned FAP trial tests 2 mg/kg weekly or every three weeks and 6 mg/kg weekly for 26 weeks. Trial-only; dosed by body weight, so the calculator cannot produce a draw.
How do you store it?
Before mixing, and after.Given in hospital or a trial clinic, so the pharmacy stores it.
ST316 goes into a vein and is prepared by hospital, clinic or trial pharmacy staff, following the product label or the trial protocol. Some products like this are ready-made solutions and others are powders mixed just before use, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Use outside a clinical trial: it is not approved anywhere
- Pregnancy or breastfeeding: no data
Stop and get help
- Severe diarrhoea, bone pain or any severe new symptom: tell the trial team (other Wnt-pathway drugs have caused gut and bone problems, though none led to dose changes with ST316)
Common effects
- Treatment-related side effects in 17 of 23 phase 1 patients, mostly low grade
- Two grade 3 events, both resolved; no dose-limiting toxicities and no related serious side effects up to 12 mg/kg
- Across 38 patients, no gut or bone side effects led to a dose cut, pause or stopping
- No side-effect table with percentages has been published
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is ST316 approved?
And where the numbers on this page come from.No. ST316 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
- RouteInto a vein (infusion)
- Checked15 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesSapience Therapeutics, FDA accepts FAP IND (14 Sep 2026)Sapience Therapeutics, AACR 2026 phase 2 results (20 Apr 2026)Sapience Therapeutics, ASCO GI 2025 phase 1 data (27 Jan 2025)Sapience Therapeutics, orphan drug designation for FAP (19 Dec 2024)Sapience Therapeutics, first IND clearance (14 Mar 2023)ClinicalTrials.gov, NCT05848739Targeted Oncology, phase 1 coverage (2025)ClinicalTrials.gov, phase 1b in FAP (NCT07729371)Sapience Therapeutics press release indexUS patent application 2022/0275036, Modified BCL9 Mimetic Peptides
What has happened recently
Not approved anywhere. The FDA cleared the first IND in March 2023 and the phase 1/2 trial (NCT05848739) began dosing in June 2023; the registry lists it as active, not recruiting, with about 130 planned. Sapience announced FDA orphan drug designation for FAP on 19 December 2024 and accepted a second IND (number 184073) for FAP in September 2026; a phase 1b FAP trial (NCT07729371, about 40 planned) is registered to start in January 2027. It has no INN or USAN, so ST316 is its only name. Sapience Therapeutics is privately held.
You can compare this against the whole library, or read how to check a seller.
What else is like ST316?
Others in Longevity and energy, side by side.If you're weighing ST316, it's worth reading Lucicebtide (ST101), MOTS-c, and Epitalon in the same class.
A cell-penetrating peptide aimed at a different beta-catenin contact from zolucatetide. Phase 1/2, with responses in 7 of 15 colorectal cancer patients on chemotherapy and bevacizumab.
- Dose
- 0.5 to 12 mg/kg weekly in dose-finding (trial)
- How often
- Once weekly (every three weeks is also being tested in FAP)
A 38-residue all-D peptide that gets into cells and brain tumours. Phase 1/2, with encouraging but uncontrolled glioblastoma data.
- Dose
- 500 mg once weekly (recommended phase 2 dose)
- How often
- Once weekly
A shot people use for energy, metabolism, and healthy aging.
- Dose
- 1 up to 5 mg per day (start low, increase slowly)
- How often
- Daily
A longevity peptide taken in short courses for sleep and anti-aging.
- Dose
- 5 up to 10 mg per day (start low, increase slowly)
- How often
- 10-20 day courses
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
- Sapience Therapeutics, FDA accepts FAP IND (14 Sep 2026)(2026)IND 184073 for FAP; phase 2 response rate 47% with 7 confirmed partial responses and 93% disease control in 15 patients; no gut or bone side effects causing dose changes across 38 patients; 11% historical comparator.
- Sapience Therapeutics, AACR 2026 phase 2 results (20 Apr 2026)(2026)Abstract CT156: 47% confirmed response rate and 93% disease control in second-line colorectal cancer; historical range 5 to 23%; no DLTs in phase 1; exposure proportional to dose.
- Sapience Therapeutics, ASCO GI 2025 phase 1 data (27 Jan 2025)(2025)Prolonged stable disease; beta-catenin moved out of the nucleus in 4 of 7; PMN-MDSCs fell in all 7 with high baseline levels.
- Sapience Therapeutics, orphan drug designation for FAP (19 Dec 2024)(2024)FDA orphan designation for familial adenomatous polyposis.
- Sapience Therapeutics, first IND clearance (14 Mar 2023)(2023)Cell-penetration segment plus a binding domain aimed at beta-catenin's first armadillo repeat; four tumour types originally planned for phase 2.
- ClinicalTrials.gov, NCT05848739(2026)Weekly 0.5 to 12 mg/kg escalation; four colorectal cancer expansion groups; active, not recruiting; about 130 planned; no results posted.
- Targeted Oncology, phase 1 coverage (2025)(2025)Treatment-related side effects in 17 of 23 patients, 2 grade 3 that resolved; J Clin Oncol 2025;43(suppl 4):286.
- ClinicalTrials.gov, phase 1b in FAP (NCT07729371)(2026)Open-label phase 1b in FAP, about 40 planned, not yet recruiting, estimated start 4 January 2027; 2 mg/kg weekly or every three weeks, or 6 mg/kg weekly, for 26 weeks.
- Sapience Therapeutics press release index(2026)Dated programme history; no INN announced for ST316, while ST101 became lucicebtide.
- US patent application 2022/0275036, Modified BCL9 Mimetic Peptides(2022)Sapience peptides based on BCL9 residues 351 to 374, 7 to 50 residues, often retro-inverso with a cell-penetrating region; ST316 is not named.
Beyond these, 2 records are indexed. Browse the records