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RedHill Biopharma Ltd. (RDHL)

RedHill Biopharma Ltd. is a specialized pharmaceutical firm concentrating its efforts mainly on therapies for digestive tract conditions and various infections. The company markets several gastrointestinal medications: Movantik, which addresses opioid-induced constipation in adults experiencing chronic non-cancer pain; Talicia, used to treat Helicobacter pylori infections in adult patients; and Aemcolo, prescribed for adults suffering from travelers' diarrhea. Its robust late-stage clinical pipeline features several promising investigational compounds. RHB-204 is currently in Phase 3 for pulmonary nontuberculous mycobacteria infections. Opaganib (Yeliva), an SK2 selective inhibitor, has completed Phase 2 for severe SARS-CoV-2 related COVID-19 pneumonia, is in Phase 2 for advanced unresectable cholangiocarcinoma, and is also being investigated in a researcher-sponsored Phase 2 study for prostate cancer. RHB-107 is progressing through Phase 2/3 trials for COVID-19 outpatients, is undergoing preclinical evaluation for advanced unresectable cholangiocarcinoma, and has successfully concluded Phase 2 studies for gastrointestinal and other solid tumors. Furthermore, RHB-104 is in Phase 3 development for Crohn's disease. RHB-102 (Bekinda) is also in Phase 3 for acute gastroenteritis and gastritis, following its successful completion of Phase 2 for irritable bowel syndrome with diarrhea. Lastly, RHB-106, an encapsulated formulation designed for bowel preparation, is preparing to commence Phase 2/3 clinical studies. Established in 2009, RedHill Biopharma Ltd. maintains its headquarters in Tel Aviv, Israel.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

RedHill Biopharma Ltd. logo

RedHill Biopharma Ltd.

NASDAQ:RDHLHealthcare
-6.91%$0.3878
AH$0.3878+0.00%vs close
Mkt Cap$3.45M
Float8.79M
O/S8.89M
Vol
$ Vol
RVOL
Inst Own3.5%
Earnings
Dilution
RedHill Biopharma Ltd. logoNASDAQ:RDHL$0.3878-6.91%
Phase Distribution
19 lead-sponsored trials·0 active·11 completed
Phase 11
Phase 1/23
Phase 26
Phase 2/32
Phase 36
Not applicable1
(1 more as collaborator)
Status Overview
Completed11
Stopped5
Expanded access1
Unknown2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

    RHB-104, Placebo

    Crohn's Disease

    Enrollment
    331
    Start
    Sep 2013
    Primary Completion
    May 2018
    Completion
    Aug 2019
    NCT01951326
  • Phase 3
    Completed

    ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

    RHB-105, Placebo

    Dyspepsia, Helicobacter Pylori Infection

    Enrollment
    119
    Start
    Nov 2013
    Primary Completion
    Jun 2015
    Completion
    Aug 2015
    NCT01980095
  • Phase 3
    Completed

    BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis

    RHB-102, Placebo Oral Tablet

    Gastroenteritis, Gastritis

    Enrollment
    330
    Start
    Dec 2014
    Primary Completion
    Feb 2017
    Completion
    Feb 2017
    NCT02246439
  • Phase 3
    Completed

    Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

    RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)

    Crohn Disease

    Enrollment
    54
    Start
    Mar 2017
    Primary Completion
    Nov 2018
    Completion
    Aug 2019
    NCT03009396
  • Phase 3
    Completed

    ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator

    RHB-105, Active Comparator

    Helicobacter Pylori Infection, Dyspepsia

    Enrollment
    455
    Start
    Jun 2017
    Primary Completion
    Oct 2018
    Completion
    Dec 2018
    NCT03198507
  • Phase 3
    Terminated

    RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

    RHB-204, Placebo

    Pulmonary Mycobacterium Avium Complex Infection, Bronchiectasis +1

    Enrollment
    12
    Start
    Dec 2020
    Primary Completion
    Aug 2023
    Completion
    Aug 2023
    NCT04616924
  • Phase 2/3
    Completed

    Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia

    Opaganib, Placebo

    COVID-19, Lung Infection

    Enrollment
    475
    Start
    Aug 2020
    Primary Completion
    Jul 2021
    Completion
    Jul 2021
    NCT04467840
  • Phase 2/3
    Terminated

    Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease

    Part A: Upamostat 200 mg, Part A: Upamostat 400 mg

    Covid19

    Enrollment
    61
    Start
    Feb 2021
    Primary Completion
    Dec 2021
    Completion
    Dec 2021
    NCT04723537
  • Phase 2
    Completed

    Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)

    RHB-104

    Relapsing Remitting Multiple Sclerosis

    Enrollment
    18
    Start
    Jun 2013
    Primary Completion
    Dec 2015
    Completion
    Jul 2016
    NCT01717664
  • Phase 2
    Completed

    Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

    BEKINDA, Placebo

    Irritable Bowel Syndrome With Diarrhea

    Enrollment
    127
    Start
    May 2016
    Primary Completion
    Jun 2017
    Completion
    Jul 2017
    NCT02757105
  • Phase 2
    Completed

    A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma

    ABC294640, Hydroxychloroquine Sulfate 200 MG

    Cholangiocarcinoma, Cholangiocarcinoma Non-resectable +3

    Enrollment
    65
    Start
    Mar 2018
    Primary Completion
    Jun 2022
    Completion
    Jun 2022
    NCT03377179
  • Phase 2
    Unknown status

    Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

    Rifamycin SV-MMX, Placebo

    Traveler's Diarrhea

    Enrollment
    142
    Start
    Jun 2024est.
    Primary Completion
    Jun 2025est.
    Completion
    Dec 2025est.
    NCT04026984
  • Phase 2
    Unknown status

    Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years

    Rifamycin SV MMX, Placebo to Rifamycin SV-MMX

    Traveler's Diarrhea

    Enrollment
    142
    Start
    Jan 2024est.
    Primary Completion
    Jan 2025est.
    Completion
    Dec 2025est.
    NCT04027894
  • Phase 2
    Completed

    A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

    Opaganib, Placebo

    Coronavirus Infections

    Enrollment
    42
    Start
    Jul 2020
    Primary Completion
    Nov 2020
    Completion
    Dec 2020
    NCT04414618
  • Phase 1/2
    Withdrawn

    Early Phase Evaluation of ABC294640 in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma or Kaposi Sarcoma

    ABC294640

    Diffuse Large B Cell Lymphoma, Kaposi Sarcoma

    Enrollment
    0
    Start
    Jul 2014
    Primary Completion
    Jun 2019est.
    Completion
    Dec 2019est.
    NCT02229981
  • Phase 1/2
    Terminated

    ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma

    Opaganib

    Multiple Myeloma

    Enrollment
    13
    Start
    Dec 2016
    Primary Completion
    May 2019
    Completion
    May 2019
    NCT02757326
  • Phase 1/2
    Withdrawn

    Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen

    Opaganib

    COVID-19, Lung Infection

    Enrollment
    0
    Start
    Aug 2020est.
    Primary Completion
    Feb 2021est.
    Completion
    Jun 2021est.
    NCT04502069
  • Phase 1
    Completed

    ABC294640 in Treating Patients With Advanced Solid Tumors

    sphingosine kinase-2 inhibitor ABC294640

    Pancreatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

    Enrollment
    22
    Start
    Aug 2011
    Primary Completion
    Aug 2014
    Completion
    Jul 2015
    NCT01488513
  • Expanded access
    No longer available

    Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

    ABC294640

    Cholangiocarcinoma, Cholangiocarcinoma Non-resectable +3

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT03414489
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