This section highlights FDA-related milestones and regulatory updates for drugs developed by Redhill Biopharma (RDHL).
Over the past two years, Redhill Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Opaganib, Opaganib, RHB-102, RHB-104, RHB-107, Talicia, and Talicia. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Opaganib - FDA Regulatory Timeline and Events
Opaganib is a drug developed by Redhill Biopharma for the following indication: Severe COVID-19 pneumonia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opaganib
- Announced Date:
- July 1, 2025
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd.
AI Summary
RedHill Biopharma Ltd. has begun recruiting patients for a Phase 2 study to test the effectiveness of opaganib combined with darolutamide in treating men with metastatic castrate-resistant prostate cancer (mCRPC). Sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd. (ANZUP) and supported by Bayer and the Ramsay Hospital Research Foundation, this study plans to enroll 60 participants across at least 10 sites in Australia and New Zealand.
Led by Professor Lisa Horvath from Sydney's Chris O’Brien Lifehouse, the research will use a precision medicine approach. A special lipid biomarker test, PCPro™, will help select patients with poor prognosis who might benefit most from the new treatment combination. The trial's main goal is to see if the combination improves the 12-month radiographic progression-free survival rate compared to standard care.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- April 16, 2025
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd. announced the new publication[2] of positive in vivo data, in the journal Diabetes, Metabolic Syndrome and Obesity, in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet (HFD)-Induced Obesity and Glucose Intolerance".
AI Summary
RedHill Biopharma recently published positive in vivo data in the journal Diabetes, Metabolic Syndrome and Obesity. The study, titled “Opaganib Promotes Weight Loss and Suppresses High-Fat Diet (HFD)-Induced Obesity and Glucose Intolerance,” demonstrates that opaganib effectively prevents metabolic decline in mice on a high-fat diet. In these preclinical models, opaganib not only improved glucose tolerance and reduced fat deposition but also promoted weight loss and prevented weight rebound after stopping semaglutide treatment. Notably, the efficacy of opaganib was found to be comparable to that of semaglutide, a well-known GLP-1 inhibitor, positioning opaganib as a promising novel treatment option. As an orally administered, non-peptide therapeutic, opaganib targets sphingosine kinase-2 (SPHK2), potentially avoiding many of the side effects and administration burdens commonly linked with GLP-1 therapies.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- February 4, 2025
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd announced the initiation of a Phase 2 clinical study to evaluate the efficacy of opaganib[3] in combination with darolutamide[4] in men with metastatic castrate-resistant prostate cancer (mCRPC).
AI Summary
RedHill Biopharma Ltd has initiated an 80-patient, placebo-controlled Phase 2 clinical study to explore the efficacy of combining opaganib with darolutamide in treating metastatic castrate-resistant prostate cancer (mCRPC) in men. The study seeks to determine if opaganib can enhance the effects of darolutamide, potentially overcoming resistance seen with standard androgen receptor pathway inhibitors. Financial support for the trial comes from Bayer BAYN and the Ramsay Hospital Research Foundation. Professor Lisa Horvath from Chris O’Brien Lifehouse, in collaboration with the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), will lead the research. Patients will be selected using the companion lipid biomarker test, PCPro, to identify those with a poorer prognosis. The primary endpoint is to achieve improved 12-month radiographic progression-free survival, offering hope for better outcomes in advanced prostate cancer treatment.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- September 30, 2024
- Estimated Event Date Range:
- October 15, 2024 - October 15, 2024
- Target Action Date:
- October 15, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd. announced the issue of a new U.S. patent for identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib[2] efficacy in treating COVID-19, valid through 2041 (U.S. Patent and Trademark Office Number: 12,115,150, date of grant to be: October 15, 2024).
AI Summary
RedHill Biopharma Ltd. announced that it has been granted a new U.S. patent aimed at identifying a novel biomarker for coronavirus pneumonia in patients requiring 60% or less inspired oxygen (FiO2). This biomarker serves as a prognostic tool for the potential efficacy of the company's investigational drug, opaganib, in treating COVID-19. The patent, issued by the U.S. Patent and Trademark Office (Patent No. 12,115,150) with a grant date set for October 15, 2024, is valid through 2041.
Post-hoc data from opaganib’s Phase 2/3 study indicated that patients with FiO2 levels at or below 60% experienced better outcomes after 14 days of treatment, including reduced need for supplemental oxygen, fewer incidences of intubation, and a notable decrease in mortality. This development strengthens RedHill’s intellectual property portfolio supporting opaganib’s advancement as a treatment for COVID-19.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- September 3, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd announced the publication of data, in the journal Microorganisms[2], from the 57-site, randomized, placebo-controlled, double-blind phase 2/3 study of opaganib[3] in COVID-19 pneumonia (NCT04467840).
AI Summary
RedHill Biopharma Ltd. announced that data from its 57-site, randomized, placebo-controlled, double-blind phase 2/3 study of opaganib in COVID-19 pneumonia has been published in the journal Microorganisms. The post hoc analysis focused on 251 hospitalized patients who required a fraction of inspired oxygen (FiO2) of up to 60%. Findings showed that those treated with opaganib experienced a 62% reduction in mortality by day 42 compared to placebo. Additionally, patients on opaganib had a 21% improvement in the time taken to breathe room air for at least 24 hours by day 14. The study also suggested that an FiO2 greater than 60% may indicate a threshold for more severe disease, potentially serving as a biomarker to help select patients for future therapies.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- August 23, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma announced that The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results
AI Summary
RedHill Biopharma announced that it is testing its drug opaganib in several metabolic disease models to evaluate its potential in preventing and treating type 2 diabetes and other obesity-related disorders. Recent in vivo studies by its partner, Apogee Biotechnology Corp., have shown positive results. The studies demonstrated that opaganib can suppress weight gain, reduce fat deposition, and improve glucose tolerance in high-fat diet models, suggesting that the drug may help both prevent and treat obesity and related complications.
Opaganib works by targeting sphingolipid metabolism, a process linked to insulin resistance, inflammation, and energy metabolism. Its ability to inhibit three key enzymes in this pathway offers a promising new approach to managing metabolic diseases. These encouraging results add to the potential of opaganib as a new therapeutic option in the fight against diabetes and obesity-related conditions.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- August 19, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd. released results from multiple in vivo studies, undertaken by RedHill’s partner, Apogee Biotechnology Corporation.
AI Summary
RedHill Biopharma Ltd. announced positive results from a series of in vivo studies performed by its partner, Apogee Biotechnology Corporation. These studies evaluated the effects of opaganib, a small molecule drug, in a high fat diet (HFD) model. The research showed that opaganib was able to suppress diet-induced body weight gain and fat deposition, while also improving glucose tolerance in the test subjects.
The findings suggest that opaganib has potential for both preventing and treating Type 2 diabetes and obesity-related disorders. By targeting multiple enzymes involved in sphingolipid metabolism, opaganib could address various underlying mechanisms such as insulin resistance and inflammation. This research supports further exploration of opaganib’s clinical use, pointing toward a promising new strategy in the fight against metabolic diseases.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- August 19, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd. announced positive results from multiple in vivo studies, undertaken by RedHill's partner, Apogee Biotechnology Corporation, showing the impact of opaganib[2] on weight gain and glucose tolerance in a high fat diet (HFD) model, supporting the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders.
AI Summary
RedHill Biopharma Ltd. announced promising results from several in vivo studies conducted by its partner, Apogee Biotechnology Corporation. These studies focused on opaganib, a novel orally administered small molecule, and its effect on weight gain and glucose tolerance in a high fat diet (HFD) model. The results showed that treatment with opaganib reduced HFD-induced weight gain and helped restore proper glucose tolerance.
This research supports opaganib's potential clinical use for both preventing and treating Type 2 diabetes and other obesity-related disorders. By targeting sphingolipid metabolism, opaganib may offer a new approach to managing conditions linked to insulin resistance and fat deposition. These encouraging findings add to opaganib’s growing profile as a potential therapy for metabolic diseases.
Read Announcement- Drug:
- Opaganib
- Announced Date:
- May 6, 2024
- Indication:
- Severe COVID-19 pneumonia
Announcement
RedHill Biopharma Ltd. announced the issue of a new Chinese patent Notice of Allowance covering opaganib[1] as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035 (Chinese Patent Application No.: 202110229970.9 issued April 29, 2024).
AI Summary
RedHill Biopharma Ltd. announced that the Chinese National Intellectual Property Administration (CNIPA) has issued a Notice of Allowance for a new patent covering opaganib. This patent—which is valid through 2035—protects opaganib’s use as a therapy designed to inhibit the replication of single-stranded RNA viruses such as the Ebola Disease Virus. According to Guy Goldberg, the company’s Chief Business Officer, this is the first China patent in the Ebola patent family and further strengthens the global intellectual property portfolio for opaganib across multiple indications. The development of opaganib, which is taken orally twice a day, builds on promising research findings, including U.S. Army studies that showed a significant increase in survival in Ebola virus disease models. This milestone supports opaganib’s potential in addressing not only viral pandemics but also other emerging health threats worldwide.
Read Announcement
Opaganib (Yeliva, ABC294640) - FDA Regulatory Timeline and Events
Opaganib (Yeliva, ABC294640) is a drug developed by Redhill Biopharma for the following indication: COVID-19 variants.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opaganib (Yeliva, ABC294640)
- Announced Date:
- August 26, 2024
- Indication:
- COVID-19 variants
Announcement
RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.
AI Summary
RedHill Biopharma Ltd. announced that the FDA has granted orphan-drug designation to opaganib for the treatment of neuroblastoma, a childhood cancer that develops from immature nerve cells and is responsible for 15% of pediatric cancer-related deaths. This designation provides the drug with a seven-year marketing exclusivity period should it be approved, along with benefits like accelerated development, faster review times, potential grant funding, and possible tax credits. Neuroblastoma, the most common malignancy in infants, typically affects children under five and presents a significant treatment challenge. With new therapeutic options urgently needed, opaganib’s designation boosts its potential as a novel oncology treatment aimed at improving outcomes for young patients. RedHill’s announcement highlights the promising future of opaganib in addressing an area of high unmet need in pediatric cancer care.
Read Announcement
RHB-102 - FDA Regulatory Timeline and Events
RHB-102 is a drug developed by Redhill Biopharma for the following indication: Relief from nausea and vomiting symptoms.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RHB-102
- Announced Date:
- February 25, 2025
- Indication:
- Relief from nausea and vomiting symptoms
Announcement
RedHill Biopharma Ltd. announced that it has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America (the "Agreement"), with Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) ("Hyloris") for RedHill's RHB-102 (Bekinda®).
AI Summary
RedHill Biopharma Ltd. announced that it has entered into an exclusive worldwide development and commercialization licensing agreement with Hyloris Pharmaceuticals SA, excluding North America. Under the arrangement, Hyloris will pay RedHill an upfront fee along with potential milestone payments of up to $60 million and mid-20s percent royalties on revenues. This deal grants Hyloris the sole right to develop, obtain regulatory approval, and market RedHill’s RHB-102 (Bekinda®) in all territories outside the United States, Canada, and Mexico. RHB-102 is a once-daily, extended-release formulation of ondansetron designed to relieve chemotherapy or radiotherapy-induced nausea and vomiting. While Hyloris will manage all aspects of overseas development, RedHill plans to continue pursuing FDA approval for RHB-102 in the U.S., further highlighting the product’s potential in oncology and supportive care.
Read Announcement
RHB-104 - FDA Regulatory Timeline and Events
RHB-104 is a drug developed by Redhill Biopharma for the following indication: In Crohn's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RHB-104
- Announced Date:
- March 12, 2025
- Indication:
- In Crohn's Disease
Announcement
RedHill Biopharma Ltd. announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter.
AI Summary
RedHill Biopharma Ltd. announced plans to move forward with its late-stage program for Crohn’s disease by launching an innovative Phase 2 study of RHB-204. The trial will uniquely enroll only patients who test positive for Mycobacterium avium subspecies paratuberculosis (MAP) with moderate to severe Crohn’s disease. The study will use novel endpoints and next-generation imaging techniques—the new gold standard for evaluating mucosal healing—to assess the treatment’s ability to eradicate MAP infection. The company is set to enter Type C discussions with the FDA, with guidance expected next quarter, to determine the regulatory path forward for RHB-204. This improved formulation is designed to reduce pill burden and enhance tolerability and safety, marking a significant step toward addressing the underlying causes of Crohn’s disease.
Read Announcement- Drug:
- RHB-104
- Announced Date:
- August 1, 2024
- Indication:
- In Crohn's Disease
Announcement
RedHill Biopharma Ltd announced the new publication of ground-breaking positive data showing that triple antimicrobial therapy with RHB-104[1] plus standard of care (SoC), targeting Mycobacterium avium subspecies paratuberculosis (MAP), is 64% more effective than SoC alone in Crohn's disease, supporting the hypothesis of a Mycobacterial basis to the disease.
AI Summary
RedHill Biopharma Ltd recently published groundbreaking Phase 3 data in the journal Antibiotics. The study showed that the triple antimicrobial therapy, RHB-104 combined with standard of care, is 64% more effective in treating Crohn’s disease compared to standard treatment alone. The therapy, which targets Mycobacterium avium subspecies paratuberculosis (MAP), supports the theory that MAP may play a crucial role in the development of Crohn’s disease. In the study, 36.7% of patients receiving RHB-104 plus standard care achieved clinical remission at week 26, compared to 22.4% of those on placebo. The findings suggest that this innovative approach could offer a new treatment avenue for Crohn’s disease, particularly for patients who do not respond to conventional therapies.
Read Announcement
RHB-107 - FDA Regulatory Timeline and Events
RHB-107 is a drug developed by Redhill Biopharma for the following indication: Non-Hospitalized COVID-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RHB-107
- Announced Date:
- April 28, 2025
- Indication:
- Non-Hospitalized COVID-19
Announcement
RedHill Biopharma Ltd. announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6).
AI Summary
RedHill Biopharma Ltd recently announced that the China National Intellectual Property Administration (CNIPA) has formally allowed a critical use of composition-of-matter patent for its investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19. The newly allowed patent (application No. 202311591091.6) protects the unique molecular structure of RHB-107, ensuring market exclusivity that goes beyond typical method-of-use claims. This protection covers the treatment of SARS-CoV-2 infections, including both wild-type and emerging variants, highlighting the drug’s broad potential and reinforcing the company’s strategic position in the global COVID-19 therapeutic market.
Moreover, this patent strengthens RedHill’s intellectual property portfolio and expands its reach in Asia, an important market for pharmaceutical innovation. The approval marks a significant milestone as the company advances its promising oral candidate for early, community-based COVID-19 treatment.
Read Announcement
Talicia - FDA Regulatory Timeline and Events
Talicia is a drug developed by Redhill Biopharma for the following indication: Low-dose rifabutin.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Talicia
- Announced Date:
- March 18, 2025
- Indication:
- Low-dose rifabutin
Announcement
RedHill Biopharma Ltd announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval..
AI Summary
RedHill Biopharma Ltd has announced plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, a treatment for Helicobacter pylori infection. The submission will use the Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP), a fast-track process that leverages a recognized reference approval. This approach aims to speed up UK drug approvals by building on established regulatory decisions, potentially allowing Talicia to receive UK approval as early as the fourth quarter of 2025. Talicia, known for its unique combination of a proton pump inhibitor with two antibiotics, is designed to address issues of antibiotic resistance in H. pylori treatment. This strategic move is significant because H. pylori infections affect a large portion of the adult population in the UK, creating an important market opportunity for an effective treatment option like Talicia.
Read Announcement- Drug:
- Talicia
- Announced Date:
- September 9, 2024
- Indication:
- Low-dose rifabutin
Announcement
RedHill Biopharma Ltd. announced the placement of low-dose rifabutin-triple therapy, Talicia, as an empirically-prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection in the newly published American College of Gastroenterology (ACG) Clinical Guideline: Treatment of H. pylori Infection, previously updated in 2017.
AI Summary
RedHill Biopharma Ltd. announced that Talicia, a low-dose rifabutin-triple therapy, has been named as an empirically prescribed first-line treatment for Helicobacter pylori infection in the newly updated American College of Gastroenterology (ACG) Clinical Guideline. The guideline, which was updated after its 2017 version, now recommends Talicia without the need for prior resistance testing—a significant shift from previous clarithromycin-based treatments. Talicia’s all-in-one formulation, taken three times a day for 14 days with food, simplifies dosing and improves patient adherence while ensuring high eradication rates. Its components, amoxicillin and rifabutin, have very low resistance rates, supporting its effectiveness in treating H. pylori. This update provides healthcare providers with a reliable and convenient first-line option to treat an infection that affects a large portion of both the U.S. and global populations.
Read Announcement
Talicia (RHB-105) - FDA Regulatory Timeline and Events
Talicia (RHB-105) is a drug developed by Redhill Biopharma for the following indication: H. pylori.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Talicia (RHB-105)
- Announced Date:
- January 21, 2025
- Indication:
- H. pylori
Announcement
RedHill Biopharma Ltd. announced the coverage of Talicia by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without the requirement for prior therapeutic steps or authorizations, for both treatment-naïve and treatment-experienced patients, effective as of January 1, 2025.
AI Summary
RedHill Biopharma announced that Talicia will now be covered by Humana’s Part D Plan. This change will give more than eight million Medicare beneficiaries access to Talicia for H. pylori therapy without requiring prior therapeutic steps or authorizations. The expanded coverage applies to both treatment-naïve and treatment-experienced patients and will become effective on January 1, 2025.
The update is significant because it simplifies access to an important treatment option recommended by clinical guidelines. Talicia, recognized as a first-line option for H. pylori treatment by the American College of Gastroenterology, is already the leading branded therapy prescribed by U.S. gastroenterologists. By removing barriers to access, RedHill Biopharma and Humana aim to improve patient care and treatment outcomes for those suffering from H. pylori infections.
Read Announcement
