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nuzefatide pevedotin

Phase 2

Pancreatic Ductal Adenocarcinoma (PDAC) | Small molecule | Oncology |Bicycle Therapeutics plc|Last Updated: Aug 13, 2026

Target and mechanism

Target class-Tide (Peptide)
ModalitySmall molecule

Also known as nuzefatide pevedotin (BT5528)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

nuzefatide pevedotin · 1 trial · 1 indication

Phase 2 1
NCT07450859A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma (PDAC)
RECRUITING39 Analytics
PHASE2RECRUITING
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Ductal Adenocarcinoma (PDAC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
Up to approximately 3 years

Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

Secondary Endpoints

Duration of Response (DoR) per RECIST v1.1
Up to approximately 3 years
Overall Survival (OS)
Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1
Up to approximately 3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
nuzefatide pevedotin (BT5528) MonotherapyEXPERIMENTAL -

Interventions

NameTypeDescription
nuzefatide pevedotin (BT5528)DRUGParticipants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria * At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent). * Measurable disease as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Lif...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07450859lastUpdatePostDate: changed
LOWAug 14, 2026NCT07450859lastUpdatePostDate: changed
LOWAug 14, 2026NCT07450859lastUpdatePostDate: changed
LOWAug 1, 2026NCT07450859lastUpdatePostDate: changed
LOWAug 1, 2026NCT07450859lastUpdatePostDate: changed
LOWAug 1, 2026NCT07450859lastUpdatePostDate: changed

Frequently asked questions about nuzefatide pevedotin

What is nuzefatide pevedotin used for?

Nuzefatide pevedotin is an investigational small molecule being studied for the treatment of metastatic Pancreatic Ductal Adenocarcinoma (PDAC). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does nuzefatide pevedotin target?

Nuzefatide pevedotin is a peptide-based small molecule, classified under the -tide (peptide) target class. Its specific molecular target has not been disclosed in available information.

Who makes nuzefatide pevedotin?

Nuzefatide pevedotin is being developed by Bicycle Therapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol BCYC.

What phase is nuzefatide pevedotin in?

Nuzefatide pevedotin is currently in Phase 2 clinical trials. It is an investigational drug and has not received FDA approval for any indication.

What clinical trials is nuzefatide pevedotin in?

Nuzefatide pevedotin is being evaluated in a Phase 2 clinical trial with the identifier NCT07450859. This study is recruiting patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the United States, with a planned enrollment of 39 participants.

Is nuzefatide pevedotin the same as BT5528?

Yes, nuzefatide pevedotin is also known as BT5528. Both names refer to the same investigational drug being developed by Bicycle Therapeutics for the treatment of metastatic Pancreatic Ductal Adenocarcinoma.