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    DRUG:

    taladegib (ENV 101)

    i
    Other names: ENV 101, LY-2940680, LY2940680, LY 2940680, ENV-IPF-101, ENV-ONC-101, ENV-101
    Associations

    News

    Trials
    Company:
    Eli Lilly, Endeavor BioMed
    Drug class:
    Hedgehog cell-signalling pathway inhibitor, SMO protein inhibitor
    Related drugs:
    Associations

    News

    Trials
    27d
    A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants (clinicaltrials.gov)
    P1, N=57, Recruiting, Endeavor Biomedicines, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    nintedanib • taladegib (ENV 101)
    3ms
    A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants (clinicaltrials.gov)
    P1, N=57, Not yet recruiting, Endeavor Biomedicines, Inc.
    New P1 trial
    |
    nintedanib • taladegib (ENV 101)
    3ms
    A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations (clinicaltrials.gov)
    P2, N=20, Completed, Endeavor Biomedicines, Inc. | Active, not recruiting --> Completed | N=44 --> 20
    Trial completion • Enrollment change
    |
    PTCH1 (Patched 1)
    |
    taladegib (ENV 101)
    4ms
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=213, Active, not recruiting, Endeavor Biomedicines, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    taladegib (ENV 101)
    10ms
    A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=94, Terminated, Eli Lilly and Company | Phase classification: P1b --> P1 | Completed --> Terminated; The study was terminated due to business considerations
    Phase classification • Trial termination
    |
    cisplatin • carboplatin • gemcitabine • Verzenio (abemaciclib) • samotolisib (LY3023414) • crenigacestat (LY3039478) • taladegib (ENV 101)
    1year
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=200, Recruiting, Endeavor Biomedicines, Inc. | Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    taladegib (ENV 101)
    over1year
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=200, Recruiting, Endeavor Biomedicines, Inc. | Not yet recruiting --> Recruiting | N=320 --> 200
    Enrollment open • Enrollment change
    |
    taladegib (ENV 101)
    2years
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=320, Not yet recruiting, Endeavor Biomedicines, Inc.
    New P2 trial
    |
    taladegib (ENV 101)
    over2years
    A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=41, Completed, Endeavor Biomedicines, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    taladegib (ENV 101)
    over2years
    A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, Endeavor Biomedicines, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    PTCH1 (Patched 1)
    |
    PTCH1 mutation
    |
    taladegib (ENV 101)
    over2years
    A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Endeavor Biomedicines, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    taladegib (ENV 101)
    almost3years
    Metastatic Basal Cell Carcinoma: Treatment with a potentially best in class Hedgehog Inhibitor, Taladegib (EADV 2023)
    Patient was further treated by vismodegib for 12 months followed by Cemiplimab. For the first time we report here that mBCC patients who were refractory to current standard of care treatments responded to taladegib with a duration of response of around one year with fewer and manageable adverse effects.
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PTCH1 (Patched 1)
    |
    PTCH1 mutation
    |
    Libtayo (cemiplimab-rwlc) • Erivedge (vismodegib) • taladegib (ENV 101)