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    DRUG:

    Mytesi (crofelemer)

    i
    Other names: SP-303T, SP-303, CRO, TRN-002
    Associations

    News

    Trials
    Company:
    Jaguar Health, Knight Therap
    Drug class:
    Anoctamin 1 inhibitor, CFTR-C1 modulator, Cl-channel activator
    Associations

    News

    Trials
    9ms
    Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID) (clinicaltrials.gov)
    P2, N=12, Recruiting, Napo Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
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    Mytesi (crofelemer)
    1year
    Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients (clinicaltrials.gov)
    P4, N=93, Completed, The University of Texas Health Science Center, Houston | Recruiting --> Completed | Trial primary completion date: Oct 2024 --> Jan 2025
    Trial completion • Trial primary completion date
    |
    Mytesi (crofelemer)
    1year
    Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID) (clinicaltrials.gov)
    P2, N=12, Not yet recruiting, Napo Pharmaceuticals, Inc.
    New P2 trial
    |
    Mytesi (crofelemer)
    over1year
    OnTARGET: Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (clinicaltrials.gov)
    P3, N=287, Completed, Napo Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Oct 2023 | Trial primary completion date: Apr 2024 --> Aug 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    Mytesi (crofelemer)
    almost2years
    Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (clinicaltrials.gov)
    P4, N=100, Recruiting, The University of Texas Health Science Center, Houston | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    Mytesi (crofelemer)
    almost2years
    Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Lindsey Russell, MD
    New P1 trial
    |
    Mytesi (crofelemer)
    almost2years
    OnTARGET: Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (clinicaltrials.gov)
    P3, N=256, Active, not recruiting, Napo Pharmaceuticals, Inc. | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial primary completion date
    |
    Mytesi (crofelemer)
    2years
    Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs. (PubMed, PLoS One)
    The average number of weekly loose/watery stools were not different between the crofelemer BID and QID treatment groups (p = 0.84). This study showed that crofelemer prophylaxis reduced the incidence/severity of neratinib-associated diarrhea in female beagle dogs without the need for any loperamide administration.
    Journal
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    EGFR (Epidermal growth factor receptor)
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    Nerlynx (neratinib) • Mytesi (crofelemer) • loperamide
    over2years
    Crofelemer for the Management of Neratinib-Associated Diarrhea in Patients With HER2+ Early-Stage Breast Cancer. (PubMed, Clin Breast Cancer)
    This is the first study to investigate crofelemer for neratinib-induced diarrhea and demonstrates crofelemer activity in this setting. Further investigation of crofelemer for diarrhea secondary to cancer treatment is needed.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    Nerlynx (neratinib) • Mytesi (crofelemer) • loperamide
    almost3years
    OnTARGET: Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (clinicaltrials.gov)
    P3, N=256, Active, not recruiting, Napo Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Nov 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Mytesi (crofelemer)
    over3years
    HALT-D: a randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane. (PubMed, Breast Cancer Res Treat)
    Despite the choice of primary endpoint being insensitive, crofelemer reduced the incidence and severity of CID in patients with HER2-positive breast cancer receiving P-based therapy. These data are supportive of further testing of crofelemer in CID.
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
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    Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Mytesi (crofelemer)
    over4years
    HALT-D: Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients (clinicaltrials.gov)
    P2, N=53, Completed, Georgetown University | Active, not recruiting --> Completed
    Clinical • Trial completion
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Mytesi (crofelemer)