Zelenectide pevedotin_Dosage, benefits & legal status
Also known as BT8009, BT-8009, zelenectide, Bicycle toxin conjugate BT8009, BCY-8116
An experimental peptide-drug conjugate for bladder cancer: a tiny bicyclic peptide delivering MMAE.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Zelenectide pevedotin?
Plain language first. The technical label stays, but it never stands alone.Overview
The same warhead as the approved antibody-drug conjugate Padcev, on a carrier one fortieth the size, in the hope of fewer skin, eye and nerve side effects. Tested in more than 600 cancer patients. In March 2026 the company said regulators no longer accepted its trial design as an approval path and deprioritised the programme.
Zelenectide pevedotin (BT8009) is a Bicycle Drug Conjugate from Bicycle Therapeutics: a synthetic 15-residue bicyclic peptide that binds Nectin-4, a protein overexpressed on urothelial and some other tumours, linked to the cell-killing payload MMAE.
What it's used for
An experimental intravenous cancer treatment for advanced urothelial (bladder) cancer. It is a cytotoxic conjugate, not a healing or wellness peptide.
How does Zelenectide pevedotin work?
What it does in the body, and where.A bicyclic peptide finds Nectin-4 on tumour cells and drops off a chemotherapy payload. It is a guided missile, not a signalling peptide.
- 01Binds Nectin-4The 15-residue peptide is pinned into two loops by a central scaffold, giving it antibody-like affinity (about 2.5 nM) for Nectin-4 and none for the related nectins.
- 02Releases MMAEA cleavable valine-citrulline linker lets tumour proteases free the payload. Bicycle says much of this happens in the space around the tumour, killing neighbouring cells too; the NCI describes release after the cell takes the conjugate in.
- 03Small and fastAt about 4.2 kDa against 150 kDa for an antibody, it reaches tissue quickly and is cleared by the kidneys in under an hour, so less payload reaches skin and eye. The freed MMAE still lasts 37 to 50 hours.
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.
Urothelial (bladder) cancer
Investigational- Human trialPreviously treated patients, 5 mg/m2 weekly, 53 people: 32.1% had a confirmed response, lasting a median 10 months. In the randomised cohort the rate was 27.6% to 29.6% across the two regimens.
- Human trialUntreated patients with pembrolizumab, 30 per arm: 55.2% to 57.7% responded by blinded review, with 24 to 31% complete responses. Progression-free survival is not yet mature.
- No dataResponse rate in single-arm and dose-selection cohorts is not proof of survival benefit. In March 2026 the company said the trial design was no longer acceptable to regulators as an approval path and deprioritised the compound.
Side effects against the antibody version
Investigational- Human trialAcross its trials, peripheral neuropathy ran 33 to 47%, skin reactions 17 to 28% and eye disorders 10 to 13%, mostly grade 1 or 2. The approved antibody conjugate enfortumab vedotin lists 53%, 58% and 40% on its label, with a boxed warning for fatal skin reactions. These are cross-trial comparisons with no randomised head-to-head.
- Human trialThe conjugate clears in under an hour but the released MMAE lasts 37 to 50 hours, and grade 3 or worse treatment-related events still reached 39 to 52% in several cohorts. A short half-life did not make it a gentle drug.
Zelenectide pevedotin is a cytotoxic cancer drug and nothing about it belongs in a healing or recovery conversation; its payload class carries a boxed warning for fatal skin reactions in the approved comparator. "Zelenectide" alone names only the Nectin-4-binding peptide with no payload. The "45% response rate" from ESMO 2024 counted confirmed and unconfirmed responses in 38 patients; at larger numbers and longer follow-up the confirmed rate was 32%. The "65%" first-line figure is "regardless of confirmation"; the confirmed figure is 58%. The pivotal phase 2/3 is no longer pivotal: it was converted to a randomised phase 2 in March 2026. "Bicycle Toxin Conjugate" and "Bicycle Drug Conjugate" are the same thing renamed.
The published record
Papers and trials about Zelenectide pevedotin
12 papers tagged human · 5 not reviews or lab · 1 clinical trial publications
5 registered trials · none with posted results
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 Zelenectide pevedotin
Evidence
Investigational
Category
Longevity and energy
Common vial
Varies
Half-life
Under an hour; the freed MMAE lasts 37 to 50 hours
How much, and do you cycle it?
The range, and whether you take breaks.5 to 6 mg/m2 of body surface, weekly or two weeks in three (trial doses), weekly, or days 1 and 8 of a 21-day cycle. 21-day cycles until progression Trial dose
Given on fixed days of a 21-day cycle, with the 6 mg/m2 regimen leaving the third week free, and continued until the cancer progresses or side effects stop it. Chemotherapy cycling, not the on-off pattern the word means in peptide forums.
How long does it stay in the body?
The half-life, and where the figure comes from.Under an hour; the freed MMAE lasts 37 to 50 hoursHuman study
The intact conjugate has a half-life of 0.42 to 0.91 hours, cleared by the kidneys. The released payload MMAE has a half-life of 37 to 50 hours, and it is the payload that causes the nerve, skin and blood-count effects.
Source: Baldini C et al., J Clin Oncol 2025, DOI 10.1200/JCO-25-00559 (49 patients)
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.
Dosed by body surface area and given by intravenous infusion over about an hour, so no vial draw can be shown and the calculator does not apply. Two regimens were compared: 5 mg/m2 on days 1, 8 and 15 of a 21-day cycle, and 6 mg/m2 on days 1 and 8. The company chose 6 mg/m2 two weeks in three as the optimal dose in 2026, with similar response rates and less neuropathy. Dose escalation found the maximum tolerated dose at 7.5 mg/m2 every two weeks.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Zelenectide pevedotin keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 33% charged residues, 67% 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
- This is an intravenous cancer chemotherapy given only inside clinical trials; there is no setting in which a reader would take it
- Trial exclusions: prior treatment with enfortumab vedotin or any MMAE-based drug, active corneal disease, grade 2 or worse nerve damage, HbA1c of 8% or above, interstitial lung disease
- Known hypersensitivity to MMAE
Stop and get help
- A spreading rash, blistering or peeling skin, since MMAE drugs can cause Stevens-Johnson syndrome and toxic epidermal necrolysis
- New or worsening numbness, tingling or weakness in hands or feet
- Fever, especially with chills, because neutropenia leaves patients open to infection
- Eye pain, blurred vision or dry eye that is getting worse
Common effects
- Peripheral neuropathy in 47% of 53 patients on 5 mg/m2 weekly, all grade 1 or 2 in that cohort
- Nausea 36%, asthenia 28%, diarrhoea 28%, hair loss 25%, fatigue 23%, anaemia 21%
- Grade 3 or worse treatment-related events in 25% on monotherapy at 5 mg/m2 weekly, and 47 to 52% in the randomised monotherapy cohorts
- Skin reactions in 17 to 28% and eye disorders in 10 to 13%, lower than the rates published for enfortumab vedotin but from different trials
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Zelenectide pevedotin approved?
And where the numbers on this page come from.No. Zelenectide pevedotin 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 (intravenous infusion)
- Checked10 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesReig Torras O et al., ASCO 2026 abstract 4563, Duravelo-1 EV-naive urothelial cancer (Bicycle-hosted poster)Loriot Y et al., ASCO 2026 abstract 4516, Duravelo-2 cohort 1 interim analysis (Bicycle-hosted slides)Petrylak DP et al., ASCO 2026 abstract 4566, Duravelo-2 cohort 2 interim analysisBaldini C et al., Journal of Clinical Oncology 2025, dose-escalation studyBicycle Therapeutics, Form 8-K exhibit 99.1, full-year 2025 results (17 Mar 2026)ClinicalTrials.gov, Duravelo-2 (NCT06225596)Mudd GE et al., Journal of Medicinal Chemistry 2022, discovery of BT8009FDA GSRS substance records, zelenectide pevedotin (UNII 0IN1TZ844E) and zelenectide (UNII LK5KSB5A2E)Bicycle Therapeutics, FDA Fast Track designation (4 Jan 2023)FDA, Padcev (enfortumab vedotin) prescribing information (2026)
What has happened recently
Not approved anywhere. FDA Fast Track for previously treated urothelial cancer (January 2023) and for NECTIN4-amplified breast and lung cancer (2025). On 17 March 2026 Bicycle Therapeutics said regulators no longer considered the Duravelo-2 phase 2/3 design an acceptable approval path, converted the trial to a randomised phase 2, closed enrolment in its breast and lung trials, cut 30% of staff and deprioritised the compound for internal development. Further randomised phase 2 data were promised for the second half of 2026.
You can compare this against the whole library, or read how to check a seller.
What else is like Zelenectide pevedotin?
Others in Longevity and energy, side by side.If you're weighing Zelenectide pevedotin, it's worth reading P110, MOTS-c, and Epitalon in the same class.
An experimental peptide-drug conjugate for bladder cancer: a tiny bicyclic peptide delivering MMAE.
- Dose
- 5 to 6 mg/m2 of body surface, weekly or two weeks in three (trial doses)
- How often
- Weekly, or days 1 and 8 of a 21-day cycle
A research peptide that blocks one route to mitochondrial fragmentation, tested only in cells and animals.
- Dose
- No human dose; 1.5 to 3 mg/kg/day by continuous pump in mice
- How often
- Continuous infusion in animals
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
- Reig Torras O et al., ASCO 2026 abstract 4563, Duravelo-1 EV-naive urothelial cancer (Bicycle-hosted poster)(2026)53 patients, 5 mg/m2 weekly, median two prior lines. Confirmed response rate 32.1% (95% CI 19.9 to 46.3), median duration of response 10.0 months, median progression-free survival 5.4 months. Treatment-related grade 3 or worse events 24.5%; peripheral neuropathy 47.2%, all grade 1 or 2.
- Loriot Y et al., ASCO 2026 abstract 4516, Duravelo-2 cohort 1 interim analysis (Bicycle-hosted slides)(2026)Untreated urothelial cancer with pembrolizumab, 30 per arm: confirmed blinded-review response 55.2% at 5 mg/m2 weekly and 57.7% at 6 mg/m2 two weeks in three. The 6 mg regimen was chosen as optimal.
- Petrylak DP et al., ASCO 2026 abstract 4566, Duravelo-2 cohort 2 interim analysis(2026)Previously treated urothelial cancer, monotherapy, 30 per arm: confirmed response 27.6% at 5 mg/m2 weekly and 29.6% at 6 mg/m2 two weeks in three. Grade 3 or worse treatment-related events 46.6% and 51.7%.
- Baldini C et al., Journal of Clinical Oncology 2025, dose-escalation study(2025)49 patients. Conjugate half-life 0.42 to 0.91 hours, released MMAE half-life 37 to 50 hours. Maximum tolerated dose 7.5 mg/m2 every two weeks. Grade 3 or worse treatment-related events 39%; peripheral neuropathy 33%, skin reactions 22%, eye disorders 10%.
- Bicycle Therapeutics, Form 8-K exhibit 99.1, full-year 2025 results (17 Mar 2026)(2026)Regulatory feedback that the Duravelo-2 design is no longer acceptable as an approval path; trial converted to randomised phase 2; Duravelo-3 and -4 enrolment closed; programme deprioritised; workforce cut about 30%.
- ClinicalTrials.gov, Duravelo-2 (NCT06225596)(2026)Randomised study in locally advanced or metastatic urothelial cancer, now listed as phase 2 with 375 estimated participants, active and not recruiting; primary completion estimated March 2028.
- Mudd GE et al., Journal of Medicinal Chemistry 2022, discovery of BT8009(2022)15-residue bicyclic peptide on a TATA scaffold, polysarcosine spacer, valine-citrulline-PAB linker, MMAE payload; exact mass about 4,174 Da; Nectin-4 affinity 2.5 nM with no binding to nectins 1, 2, 3 or 5.
- FDA GSRS substance records, zelenectide pevedotin (UNII 0IN1TZ844E) and zelenectide (UNII LK5KSB5A2E)(2026)Zelenectide is the Nectin-4-binding bicycle alone; pevedotin names the spacer, linker and MMAE. The GSRS mass fields for both records are internally inconsistent; the papers' 4.2 kDa is used here.
- Bicycle Therapeutics, FDA Fast Track designation (4 Jan 2023)(2023)Fast Track for BT8009 monotherapy in previously treated locally advanced or metastatic urothelial cancer.
- FDA, Padcev (enfortumab vedotin) prescribing information (2026)(2026)The approved Nectin-4 antibody-drug conjugate: boxed warning for Stevens-Johnson syndrome and toxic epidermal necrolysis; skin reactions 58%, peripheral neuropathy 53%, eye disorders 40% as a single agent.
Beyond these, 15 records are indexed. Browse the records