Pipeline

RedHill is advancing the management of gastrointestinal and infectious diseases with an extensive late-stage development pipeline of proprietary, oral, small-molecules with multiple near-term milestones, designed to help patients live extraordinary lives:

Drug Candidate Pre-Clinical Phase 1 Phase 2 Phase 3 NDA
RHB-204

RHB-204 is a fixed-dose oral capsule undergoing a Phase 3 clinical study to evaluate its efficacy as a first-line, stand-alone treatment of pulmonary Nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC).

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NTM disease
Ongoing US Phase 3 Study
RHB-104

RHB-104 is an orally-administered, all-in-one antibiotic combination therapy, with intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 has completed a positive first Phase 3 study in Crohn’s disease, meeting its primary and key secondary endpoints, as well as a positive Phase 2a proof-of-concept study in relapsing remitting multiple sclerosis.

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Crohn's disease
Completed positive Phase 3 study
RHB-102

RHB-102 is an oral, bi-modal extended-release (24 hours), once-daily pill formulation of the antiemetic drug ondansetron, in development for multiple gastrointestinal indications.

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Gastroenteritis and gastritis
Completed positive US Phase 3 study

RHB-102 (24 mg) completed a positive randomized, double-blind, placebo-controlled U.S. Phase 3 study demonstrating its safety and efficacy in the treatment of acute gastroenteritis and gastritis and successfully meeting the study’s primary endpoint.

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IBS-D
Completed positive US Phase 2 study

RHB-102 (12 mg) completed a positive randomized, double-blind, placebo-controlled U.S. Phase 2 demonstrating its safety and efficacy in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), successfully meeting the study’s primary endpoint.

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RHB-106
Phase 2/3 studies planned

RHB-106 is a flavorless, odorless, easy to take oral capsule formulation for bowel preparation.

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Opaganib

Opaganib is a first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, under development for multiple indications. Opaganib is an orally-administered, selective inhibitor of sphingosine kinase-2 (SK2), a lipid kinase with multiple cellular functions - potentially inhibiting tumor growth, pathological inflammation, and viral replication.

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COVID-19
Ongoing global Phase 2/3 study

Opaganib’s unique mechanism of action combines potent antiviral and anti-inflammatory activities, targeting a host cell component and minimizing likelihood of resistance of emerging COVID-19 variants.

Opaganib is being evaluated as a treatment for severe COVID-19 pneumonia in a global Phase 2/3 study that has completed all patient treatment and follow up, with top-line results upcoming. It has also completed a U.S. Phase 2 study with positive safety and efficacy signals.

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Cholangiocarcinoma
Ongoing Phase 2 study

Opaganib is being studied in a single-arm Phase 2a clinical study in patients with advanced, unresectable, intra-hepatic, perihilar and extra-hepatic cholangiocarcinoma – an orphan indication with strong unmet medical need.

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Prostate cancer
Ongoing Phase 2 study

Opaganib is being studies in an investigator-sponsored Phase 2 study evaluating the safety and efficacy of opaganib in metastatic castration-resistant prostate cancer (mCRPC) that is progressing during treatment with androgen-signaling blockers abiraterone or enzalutamide.

RHB-107
Ongoing Phase 2/3 study

RHB-107 (INN: upamostat) (formerly MESUPRON) is a first-in-class orally-administered potent inhibitor of serine proteases targeting multiple indications, including COVID-19, cancer, inflammatory lung diseases and gastrointestinal diseases.

RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment of non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen.

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* Estimated timeline/indication in the pipeline is subject to changes in development plans and regulatory requirements/ clarifications, including complementary /additional studies.

** The safety and efficacy of the agents for the indications under investigation have not been established.