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LY3537021

Phase 2

Nausea | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07169851A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With CancerPHASE2 RECRUITING 204Nov 28, 2025Feb 1, 2027Jun 4, 202667 United States, Australia +8
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Study Endpoints
Primary Endpoints
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
24 to 120 hours after first chemotherapy infusion

CR defined as no vomiting and no rescue medication

Secondary Endpoints
Proportion of Participants with a CR to CINV
Zero to 120 hours after the first chemotherapy infusion
Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication
Zero to 120 hours after the first chemotherapy infusion
Proportion of Participants with a Response of Less than or Equal to (≤)3 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication
Zero to 120 hours after the first chemotherapy infusion
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3537021 + Antiemetic TherapiesEXPERIMENTALPrior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
Placebo + Antiemetic TherapiesPLACEBO_COMPARATORPrior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
Interventions
NameTypeDescription
LY3537021DRUGAdministered SC
PlaceboDRUGAdministered SC
Standard of Care Antiemetic TherapiesDRUG5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
Background ChemotherapyDRUGCisplatin or anthraxyline and cyclophosphamide (AC) administered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg/m²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each c...

Countries:United StatesAustraliaChinaFranceItalyJapanRomaniaSpainTaiwanTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07169851lastUpdatePostDate: changed
LOWJun 4, 2026NCT07169851lastUpdatePostDate: changed
LOWJun 4, 2026NCT07169851lastUpdatePostDate: changed
LOWJun 4, 2026NCT07169851lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07169851primaryCompletionDate: changed
LOWMay 24, 2026NCT07169851studyFirstPostDate: changed