RedHill Biopharma Ltd. develops medicines for gastrointestinal and infectious diseases. It operates through Commercial Operations, and the Research and Development segments. The Commercial Operations segment covers all areas relating to the commercial sales and is being performed by the subsidiary in the U.S. The Research and Development segment includes the study and licensing of therapeutic candidates. Its products include Talicia, Movantik, and Aemcolo. The company was founded by Dror Ben-Asher and Ori Shilo on August 3, 2009 and is headquartered in Tel Aviv, Israel.
相关临床试验
28
11 进行中
药物批准
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批准总数
监管机构
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监管机构数
成立时间
2009
进行中（未招募）
8
28.6%
已完成
11
39.3%
No Longer Available
1
3.6%
尚未招募
3
10.7%
终止
3
10.7%
撤回
2
7.1%
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- RedHill Biopharma secured exclusive global and U.S. commercialization rights to Rebyota and Clenpiq from Ferring Pharmaceuticals for a $12 million upfront payment plus tiered royalties and milestones. - The two FDA-approved gastrointestinal products generated approximately $37.5 million in combined 2025 U.S. net sales, with Rebyota contributing $16.9 million and Clenpiq $20.6 million. - The transaction, fully funded by RedHill's $18 million Talicia divestiture to Apotex, completes a strategic repositioning toward a larger, fully controlled commercial GI business. - Rebyota is the first and only single-dose FDA-approved fecal microbiota transplant for preventing recurrent C. diff infection, with a demonstrated success rate exceeding 70%.
- The FDA granted rare pediatric disease designation to RedHill's opaganib for neuroblastoma, adding to its existing orphan drug designation for the same indication. - New preclinical data presented at AACR 2026 showed opaganib destabilizes the oncogenic driver n-Myc and enhances apoptosis as a potential add-on to chemotherapy in high-risk neuroblastoma models. - The RPD designation provides eligibility for a Priority Review Voucher, while the orphan drug designation offers seven years of marketing exclusivity, PDUFA fee waivers, and tax credits upon approval. - Approximately half of neuroblastoma patients have high-risk disease with a five-year survival of roughly 50%, underscoring the urgent need for new therapeutic options.
- The Bundibugyo ebolavirus outbreak has escalated to 3,221 confirmed cases and 1,407 deaths, with no approved medications or vaccines available for this rare subtype. - RedHill Biopharma is in active partnership discussions with the African Medicines Agency, Ugandan Ministry of Health, and MUST to clinically evaluate oral host-directed antiviral opaganib. - Phase 3 COVID-19 data showed a 70.2% mortality reduction when opaganib was added to remdesivir plus corticosteroids (6.98% vs. 23.4%, p=0.034) with improved viral RNA clearance. - Preclinical USAMRIID-funded studies demonstrated opaganib's inhibition of Ebola virus in human macrophages, increased survival in animal models, and synergistic effects with remdesivir.
- RedHill Biopharma's RHB-204 demonstrated comparable MAP killing efficacy to RHB-104 in vitro testing, achieving similar antimicrobial activity with lower doses of two active ingredients. - The next-generation formulation offers potential for reduced toxicity and side effects while maintaining the therapeutic approach that showed 64% improvement over standard care in Phase 3 trials. - RHB-204's planned Phase 2 study will be the first clinical trial in a specifically defined MAP-positive Crohn's disease patient population, representing a potentially paradigm-changing treatment approach. - The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033, presenting significant commercial opportunity for novel therapies.
- New preclinical data presented at the 2026 AACR Annual Meeting demonstrates that opaganib enhances the efficacy of oxaliplatin plus doxorubicin chemotherapy in high-risk neuroblastoma by destabilizing n-Myc oncogene. - A separate study shows opaganib pre-treatment followed by low-dose diABZI potentiates STING-mediated effects and may augment anti-tumor immunity in triple-negative breast cancer models. - Opaganib, a first-in-class oral sphingosine kinase-2 inhibitor, has received FDA Orphan Drug and Rare Pediatric Disease designations for neuroblastoma treatment. - The drug has demonstrated safety and tolerability in over 470 people across multiple clinical studies and is currently being evaluated in a Phase 2 prostate cancer trial.
- Cumberland Pharmaceuticals has launched national sales promotion of Talicia, an FDA-approved all-in-one oral capsule for treating H. pylori infection in adults. - Talicia is the only treatment combining omeprazole, amoxicillin and rifabutin, and is now listed as a first-line option in American College of Gastroenterology guidelines. - H. pylori affects approximately 35% of the U.S. adult population and is classified by WHO as a Group 1 carcinogen, contributing to an estimated 11,000 gastric cancer deaths annually. - The drug has patent protection through 2042 and eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation.
- RedHill Biopharma is developing RHB-102, a once-daily oral ondansetron formulation, to address gastrointestinal side effects associated with GLP-1/GIP receptor agonist therapies like Ozempic and Mounjaro. - The company plans to initiate a Phase 2 proof-of-concept study for GLP-1-associated GI side effects, leveraging positive Phase 3 results in gastroenteritis and Phase 2 results in IBS-D. - Up to 50% of patients discontinue GLP-1 therapies within three months due to GI side effects, potentially reducing the GLP-1 market value by $35 billion by 2030 according to Goldman Sachs. - RHB-102 is supported by decades of ondansetron clinical use with over 22 million annual U.S. emergency room prescriptions and targets multiple GI indications through the FDA 505(b)(2) pathway.
- RedHill Biopharma announced positive in vivo results showing opaganib combined with venetoclax reduced chronic lymphocytic leukemia cells by 50% compared to controls in mice studies. - The combination therapy targets venetoclax resistance through opaganib's inhibition of sphingosine kinase 2 (SPHK2), which is overexpressed in venetoclax-resistant CLL cells. - Venetoclax resistance represents a growing therapeutic challenge for the $2.5 billion blockbuster CLL therapy, with leukemic cells persisting despite combination treatments. - Opaganib has demonstrated safety in over 470 clinical participants and is currently being evaluated in a Phase 2 prostate cancer trial with darolutamide.
- DelveInsight's 2025 assessment reveals a robust prostate cancer pipeline with 140+ companies developing 150+ treatment therapies across various clinical phases. - Recent clinical milestones include Novartis's positive Phase III PSMAddition trial results for Pluvicto combination therapy and MSD-Daiichi Sankyo's initiation of the IDeate-Prostate01 trial for ifinatamab deruxtecan. - Emerging therapies span diverse mechanisms including radioligand therapy, antibody-drug conjugates, and EZH2 inhibitors, with companies like Telix Pharmaceuticals, Pfizer, and AstraZeneca leading development efforts. - The pipeline includes promising late-stage candidates such as 177Lu-DOTA-rosopatamab, mevrometostat, and capivasertib, targeting various stages of prostate cancer progression.
- Cumberland Pharmaceuticals and RedHill Biopharma announced a strategic partnership to jointly commercialize Talicia, an FDA-approved treatment for Helicobacter pylori infection in adults. - The companies will form a jointly owned entity with Cumberland providing $4 million in investment capital and assuming distribution responsibilities for the product that generated $8 million in net revenues in 2024. - Talicia is the only all-in-one treatment combining omeprazole, amoxicillin, and rifabutin, achieving >90% eradication rates and now listed as a first-line option in updated American College of Gastroenterology guidelines. - The product benefits from patent protection through 2042, eight years of market exclusivity under QIDP designation, and broad insurance coverage including 70% of commercial plans and 60% of government plans.
