Zolucatetide (FOG-001)_Dosage, benefits & legal status
Also known as FOG-001, FOG001
A stabilised helical peptide built to get inside cells and stop beta-catenin binding TCF. Phase 1/2, with responses in desmoid tumours.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Zolucatetide (FOG-001)?
Plain language first. The technical label stays, but it never stands alone.Overview
Beta-catenin drives desmoid tumours and the polyps of familial adenomatous polyposis (FAP), and it has been very hard to drug. Of 38 desmoid patients treated by February 2026, all 25 who could be assessed had some tumour shrinkage, and 14 of the 19 with two follow-up scans had an objective response. Two patients with FAP saw their duodenal polyps improve, and a dedicated FAP group opened in October 2026. No peer-reviewed paper has been published.
Zolucatetide is a stabilised, cell-penetrating alpha-helical peptide (Parabilis calls the class Helicons) that binds beta-catenin inside the cell and blocks its contact with the TCF/LEF transcription factors. The structure deposited with the FDA is a bridged macrocycle with two carbon-carbon double-bond bridges and several non-natural residues (C102H134N18O25S2, about 2,076 Da), but no residue list has been published. Parabilis Medicines, founded in 2015 as FOG Pharmaceuticals on Gregory Verdine's Harvard work, develops it.
What it's used for
An experimental intravenous drug in a phase 1/2 trial for desmoid tumours, FAP and other cancers driven by the Wnt/beta-catenin pathway. Not available outside the trial.
How does Zolucatetide (FOG-001) work?
What it does in the body, and where.Zolucatetide gets inside cells and stops beta-catenin switching on cancer-driving genes.
- 01The broken brakeNormally the APC protein keeps beta-catenin levels low. In FAP, APC is faulty from birth; in many tumours APC is lost or the beta-catenin gene (CTNNB1) is mutated, so beta-catenin builds up.
- 02The switchExcess beta-catenin enters the nucleus and binds TCF/LEF proteins on DNA, turning on Wnt genes that drive growth and invasion.
- 03Blocking the contactZolucatetide is a helical peptide braced to hold its shape and cross cell membranes. It binds beta-catenin directly and blocks the TCF/LEF contact, so it should work whichever gene carries the mutation. No binding or potency figures have been published.
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.
Desmoid tumours
Investigational- Human trialFirst 12 patients: all 10 assessable had tumour shrinkage, with 4 confirmed partial responses of 35 to 52%.
- No dataThe 100% figures in coverage are disease control, not response, and come from small subsets without a control group.
Desmoid tumours, larger group
Investigational- Human trialBy February 2026, 38 had been treated; all 25 assessable had shrinkage, and 14 of 19 with two follow-up scans had an objective response.
Familial adenomatous polyposis
Investigational- human-earlyTwo patients with FAP and desmoid tumours: duodenal polyps improved from Spigelman stage IV to near normal, and from stage II to stage I.
- No dataPolyp counts and sizes were not reported; a dedicated dose-ranging FAP group opened on 14 October 2026.
Colorectal cancer
Investigational- Human trialOn its own it produced stable disease and falls in tumour DNA in some patients but no reported responses; development moved to combinations.
'100% of desmoid patients responded' confuses disease control with response: every assessable patient's tumour shrank, but the objective response rate was 80% (4 of 5) in the first dataset and 74% (14 of 19) later. One news write-up described the first desmoid group as 83% male; the poster says 83% female, and the same article swapped the AST and ALT figures. Parabilis calls it 'stabilised', not 'stapled', though the deposited structure has two carbon bridges consistent with stapling. Doses are in mg/m2, not mg/kg as for ST316. The October 2026 FAP group was planned in the May 2026 IPO filing, and that filing already reported polyp improvement in both FAP patients; the new detail in October was the second patient's change from Spigelman stage IV to a near-normal duodenum. FAP polyps are pre-cancerous, so that group is not a cancer treatment group.
The published record
Papers and trials about Zolucatetide (FOG-001)
1 papers tagged human · 0 not reviews or lab · 0 clinical trial publications
1 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 Zolucatetide (FOG-001)
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.36 to 480 mg/m2 in dose-finding (trial), repeated 28-day cycles (exact schedule not published). Repeated 28-day cycles Trial dose
Given in continuous 28-day cycles for as long as it helps; desmoid patients had been treated for a median of about nine months by mid-2026. Cancer-treatment cycles, not the on-off pattern the word means in peptide forums.
Not publishedNo figure
The company reports exposure rising in proportion to dose with little variation between patients, but no half-life, peak or clearance figures.
Source: Cote GM et al., CTOS 2025 poster (qualitative only)
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.
Intravenous infusion in repeated 28-day cycles; the days of dosing within a cycle have not been published. Dose escalation ran from 36 to 480 mg/m2 over six levels, and the first desmoid group received 72, 240 or 480 mg/m2, most at 240. No maximum tolerated or recommended dose has been disclosed; a separate study is choosing induction and maintenance doses for phase 3. Trial-only; dosed by body surface area, 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.
Zolucatetide (FOG-001) 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, and Wnt signalling matters for development
- Fragile bones: the company reports occasional stress fractures at higher doses
Stop and get help
- New bone pain during treatment, a possible stress fracture
- Severe dizziness or fainting: low aldosterone was seen in both patients given the highest dose
Common effects
- Treatment-related side effects in 10 of 12 desmoid patients (83%); grade 3 in 2, both at the top dose of 480 mg/m2
- Tiredness 58%, hair loss 50%, nausea 42% and raised AST 42%
- Raised ALT 33%, raised bilirubin 33% and nosebleeds 33%
- Low aldosterone (hypoaldosteronism) 25%
- No grade 4 or 5 events, no serious treatment-related events and no stopping for side effects at the August 2025 cut-off
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Zolucatetide (FOG-001) approved?
And where the numbers on this page come from.No. Zolucatetide (FOG-001) 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); a version injected under the skin is in development
- Checked15 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesParabilis Medicines, FAP dose-ranging study (14 Oct 2026)FDA GSRS substance record, zolucatetide (UNII GFP3KA6HMQ)Cote GM et al., CTOS 2025 posterParabilis Medicines, ESMO 2025 data (17 Oct 2025)Parabilis Medicines, Fast Track designation (12 Nov 2025)Parabilis Medicines, early FAP evidence (5 Mar 2026)Parabilis Medicines, orphan drug designation (11 Mar 2026)Parabilis Medicines, Form S-1 (May 2026)ClinicalTrials.gov, NCT05919264Renaissance Capital, Parabilis IPO (Jun 2026)Parabilis at Morgan Stanley conference (transcript, Sep 2026)
What has happened recently
Not approved anywhere. It is being tested in one phase 1/2 trial (NCT05919264, started May 2023, about 619 planned, more than 150 dosed by March 2026). Parabilis announced FDA Fast Track designation for desmoid tumours on 12 November 2025 and orphan drug designation on 11 March 2026. Parabilis plans a placebo-controlled phase 3 in desmoid tumours in the first half of 2027. FOG Pharmaceuticals renamed itself Parabilis Medicines in October 2024 and listed on Nasdaq (PBLS) in June 2026, raising $670 million. The name zolucatetide replaced the code FOG-001 in early 2026.
You can compare this against the whole library, or read how to check a seller.
What else is like Zolucatetide (FOG-001)?
Others in Longevity and energy, side by side.If you're weighing Zolucatetide (FOG-001), it's worth reading ST316, Lucicebtide (ST101), and MOTS-c in the same class.
A stabilised helical peptide built to get inside cells and stop beta-catenin binding TCF. Phase 1/2, with responses in desmoid tumours.
- Dose
- 36 to 480 mg/m2 in dose-finding (trial)
- How often
- Repeated 28-day cycles (exact schedule not published)
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
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
- Parabilis Medicines, FAP dose-ranging study (14 Oct 2026)(2026)FAP group opened; one patient improved from Spigelman stage IV to a near-normal duodenum, another from stage II to stage I; more data expected in the first quarter of 2027.
- FDA GSRS substance record, zolucatetide (UNII GFP3KA6HMQ)(2026)C102H134N18O25S2, MW 2,076.4; CAS 2883154-91-2 and 3044032-95-0; deposited structure with 14 stereocentres and 2 double-bond centres; no sequence field.
- Cote GM et al., CTOS 2025 poster(2025)Dose levels 36 to 480 mg/m2; 12 desmoid patients, 4 confirmed partial responses; full treatment-related side-effect table.
- Parabilis Medicines, ESMO 2025 data (17 Oct 2025)(2025)All 10 evaluable desmoid patients had tumour shrinkage; response rate 80% (4 of 5) among those with more than one scan.
- Parabilis Medicines, Fast Track designation (12 Nov 2025)(2025)Fast Track for desmoid tumours; designed to work with APC or beta-catenin mutations.
- Parabilis Medicines, early FAP evidence (5 Mar 2026)(2026)Duodenal polyposis improved from Spigelman stage II to I at 60 weeks with a 52.2% desmoid shrinkage; more than 150 patients dosed.
- Parabilis Medicines, orphan drug designation (11 Mar 2026)(2026)Orphan designation for desmoid tumours; activity in five Wnt-driven tumour types.
- Parabilis Medicines, Form S-1 (May 2026)(2026)38 desmoid patients treated, 25 evaluable, 14 of 19 (74%) objective responses; stable disease and falls in tumour DNA, with no responses reported, on monotherapy in colorectal cancer; one liver cancer response; phase 3 planned for 2027.
- ClinicalTrials.gov, NCT05919264(2026)Phase 1/2, recruiting since May 2023, about 619 planned; intravenous, with subcutaneous parts; 28-day cycles; no results posted.
- Renaissance Capital, Parabilis IPO (Jun 2026)(2026)IPO priced 10 June 2026 at $20 a share, raising $670 million on Nasdaq (PBLS).
- Parabilis at Morgan Stanley conference (transcript, Sep 2026)(2026)Phase 3 of about 150 patients planned; occasional stress fractures at higher doses with unchanged bone scans; median treatment about nine months.
Beyond these, 1 records are indexed. Browse the records