A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).

Start Date09 Jul 2024

Sponsor / Collaborator

Ipsen SA

NCT06016842 / RecruitingPhase 3

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).
PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.
The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.
This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.
The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).
This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Start Date31 Aug 2023

Sponsor / Collaborator

Ipsen SA

NCT05627362 / Active, not recruitingPhase 2

A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC).

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

Start Date29 Dec 2022

Sponsor / Collaborator

Ipsen SA

100 Clinical Results associated with Elafibranor

100 Translational Medicine associated with Elafibranor

100 Patents (Medical) associated with Elafibranor

108

Literatures (Medical) associated with Elafibranor

01 Nov 2024·Journal of Lipid Research

Humanized Monoacylglycerol Acyltransferase 2 Mice Develop Metabolic Dysfunction-Associated Steatohepatitis

Article

Author: Gao, Grace L. ; Frietze, Karla K. ; Gao, Grace L ; Frietze, Karla K ; Taylor, Rulaiha ; Nickels, Joseph T. ; Gallagher, Grant ; Corbalan, Jose ; Nickels, Joseph T ; Jagadeesan, Pranavi

Mice lacking monoacylglycerol acyltransferase 2 (mMGAT2¹) are resistant to diet-induced fatty liver, suggesting hMOGAT2 inhibition is a viable option for treating metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH). We generated humanized hMOGAT2 mice (HuMgat2) for use in pre-clinical studies testing the efficacy of hMOGAT2 inhibitors for treating MASLD/MASH. HuMgat2 mice developed MASH when fed a steatotic diet. Computer-aided histology revealed the presence of hepatocyte cell ballooning, immune cell infiltration, and fibrosis. Hepatocytes accumulated Mallory-Denk bodies containing phosphorylated p62/sequestosome-1-ubiquintinated protein aggregates likely caused by defects in autophagy. Metainflammation and apoptotic cell death were seen in the livers of HuMgat2 mice. Treating HuMgat2 mice with elafibranor reduced several MASH phenotypes. RNASeq analysis predicted changes in bile acid transporter expression that correlated with altered bile acid metabolism indicative of cholestasis. Our results suggest that HuMgat2 mice will serve as a pre-clinical model for testing hMOGAT2 inhibitor efficacy and toxicity and allow for the study of hMOGAT2 in the context of MASH.

01 Sep 2024·Drugs

Elafibranor: First Approval

Review

Author: Blair, Hannah A

Elafibranor (IQIRVO^®) is a first-in-class peroxisome proliferator-activated receptor (PPAR) agonist being developed by Ipsen, under license from Genfit, for the treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). On 10 June 2024, elafibranor received accelerated approval based on reduction of alkaline phosphatase (ALP) in the USA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Elafibranor has also received a positive opinion in the EU. This article summarizes the milestones in the development of elafibranor leading to this first approval for PBC.

01 Sep 2024·Drugs

Correction: Elafibranor: First Approval

Author: Blair, Hannah A

132

News (Medical) associated with Elafibranor

15 Nov 2024

·www.globenewswire.com

Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus

Ipsen presents 3 late-breaking presentations and 8 abstracts across rare cholestatic liver disease portfolio at AASLD 2024Iqirvo approved for use in the U.S. in June 2024, in the E.U. in September 2024 and in the U.K. in October 2024 PARIS, FRANCE, 15 November 2024 Ipsen (Euronext: IPN; ADR: IPSEY) announced today late-breaking data for Iqirvo® (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE® study at the American Association for the Study of Liver Disease (AASLD) congress. The late-breaking presentations (Abstract #5041 and Abstract #5042) report on biomarkers of cholestasis, stabilization of surrogate markers of liver fibrosis and moderate-to-severe pruritus data for up to three years in Iqirvo-treated patients. Additionally, exploratory endpoints in fatigue and sleep were evaluated using patient-reported outcomes tools. “Over three years, Iqirvo data suggest sustained efficacy and support the safety profile of the medicine. Importantly, when patients tell me they are less impacted by itch and fatigue—that matters to me as a physician,” said Dr. Kris Kowdley, Director at The Liver Institute Northwest, Washington and a primary investigator on the ELATIVE study. “Treatment with Iqirvo had an impact on symptoms of pruritus and surrogate markers of fibrosis, which are important findings for people living with PBC.” “Fatigue is a symptom often reported by people living with PBC and is also very challenging to manage,” said Dr. Mark Swain, Department of Medicine, Cumming School of Medicine, University of Calgary, Canada. “Patients treated with Iqirvo reported improvement in fatigue and sleep, across several patient-reported outcome measures.” The open-label extension (OLE) included 138 patients who completed the double-blind period of the Phase III ELATIVE® study1. This interim analysis was performed after at least one year of treatment with Iqirvo in the OLE (up to three years total). In patients receiving three years of continuous treatment with Iqirvo across the double-blind period and OLE (n=13), 85 percent had a biochemical response (n=11/13; ALP <1.67 x ULN, with ≥ 15% reduction from baseline and total bilirubin ≤ ULN) and 39 percent achieved ALP normalization (n=5/13) at week 156. Surrogate markers of liver fibrosis, liver stiffness measurements (n=23) and enhanced liver fibrosis (ELF™) (n=19) scores, suggest stabilization when measured from baseline to week 130. In patients continuously receiving Iqirvo for up to 156 weeks, pruritus improvements were sustained for patients with moderate or severe pruritus at baseline (n=5). No new safety findings were observed. The most common treatment-emergent adverse events (>10 percent) occurring more frequently in patients treated with Iqirvo than placebo in the double-blind period of the trial (abdominal pain, diarrhea, nausea and vomiting) were also reported in the OLE. The impact of Iqirvo on fatigue and sleep were investigated as an exploratory endpoint in the OLE.2 Changes in fatigue or sleepiness (including normal sleep) were reviewed from baseline to week 104 looking at the minimal clinically important differences and categorical changes (n=48). Fatigue and sleep improvements for patients treated with Iqirvo were observed at week 104 across three patient-reported outcome (PRO) tools. In patients with moderate-to-severe fatigue or excessive sleepiness at baseline, clinically meaningful improvements were observed after 104 weeks of treatment with Iqirvo in 56 percent (n=18) of patients according to the PRO Measurement Information System (PROMIS) Fatigue Short Form 7a, 50 percent (n=24) of patients according to the fatigue domain of the PBC-40, and 69 percent (n=16) of patients according to the Epworth Sleepiness Scale (ESS). These are interim data and have not been submitted to regulatory agencies. A confirmatory study of Iqirvo is ongoing (NCT06016842). “People living with PBC tell us just how devastating this disease can be for patients and their families,” said Sandra Silvestri, EVP and Chief Medical Officer, Ipsen. “Data like these continue to provide prescribers with a clear rationale for Iqirvo. As the first-in-class PPAR approved for the treatment of PBC, Iqirvo is on track to be the treatment of choice for patients living with PBC. Ipsen is committed to being a leader the rare liver community can count on.” About PBCPBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins (cholestasis) and chronic inflammation causes irreversible fibrosis (scarring) of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the U.S.,3 the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated, may lead to liver transplant and in some cases, premature death. The high symptom burden of PBC can also have an impact on daily life. Iqirvo (elafibranor) posters presented at AASLD Poster or Oral # Full Title Authors Poster, Abstract [5041]Monday 18 November13:00–14:00Poster Session IV Long-term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE® trial up to 3 years Kris V. Kowdley et al. Poster, Abstract [5042]Monday 18 November13:00–14:00Poster Session IV Impact of elafibranor on fatigue in patients with primary biliary cholangitis: Interim results from the long-term open-label extension of the ELATIVE® trial Mark Swain et al. Poster, Abstract [4274]Monday 18 November13:00–14:00Poster Session IV Beyond the mean: Exploring the impact of baseline alkaline phosphatase levels on endpoints in primary biliary cholangitis Cynthia Levy et al. Oral, Abstract Parallel, ePoster [43]Monday 18 November11:00–11:15 Human Cholestatic, PBC and other Biliary Disorders in Children and Adults One-year treatment with elafibranor in the Phase III ELATIVE® trial improves GLOBE and UK-PBC prognostic scores Kris V. Kowdley et al. Poster, Abstract [4292]Monday 18 November13:00–14:00Poster Session IV Use of machine learning (ML) models to stratify response patterns to first-line treatment of primary biliary cholangitis (PBC) with ursodeoxycholic acid (UDCA) Seema T. Meloni et al. Poster, Abstract [4349]Monday 18 November13:00–14:00Poster Session IV Elafibranor has no impact on markers of renal function in primary biliary cholangitis: results from the Phase III ELATIVE® trial Marcelo Kugelmas et al. Poster, Abstract [4358]Monday 18 November13:00–14:00Poster Session IV Economic burden of patients with primary biliary cholangitis and experiencing fatigue or pruritus in the United States Nisreen Shamseddine et al. About Iqirvo® (elafibranor) 80 mg tabletIqirvo is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR), indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. While the mechanism is not well understood, pharmacological activity that is potentially relevant to Iqirvo therapeutic effects includes inhibition of bile acid synthesis through activation of PPAR-alpha and PPAR-delta. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC. Iqirvo was granted U.S. FDA accelerated approval in June 2024, EU conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) approval in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA and EMA approvals are contingent on the further verification of clinical benefit. Iqirvo is currently in regulatory processes with other authorities. Iqirvo (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021. INDICATIONIQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of UseUse of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). IMPORTANT SAFETY INFORMATIONMyalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis. Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care. Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO. Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO. Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO. Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated. Drug-Drug Interactions IQIRVO may reduce the systemic exposure of progestin and ethinyl estradiol (CYP3A4 substrates), which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose. CPK elevation and/or myalgia occurred in patients on IQIRVO monotherapy. Co-administration of IQIRVO and HMG-CoA reductase inhibitors can increase the risk of myopathy. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy. Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor resulting in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO. Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible. Use in Special Populations Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Ipsen Biopharmaceuticals, Inc. adverse event reporting line at 1-855-463-5127 or https://www.ipsen.com/contact-us/.Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production. IQIRVO is not recommended during breastfeeding and for at least 3 weeks following last dose of IQIRVO because the risk to breastfed child cannot be excluded. Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose. The most common adverse events occurring in ≥10% of patients were weight gain (23%), abdominal pain (11%), nausea (11%), vomiting (11%), and diarrhea (11%). You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127. Please see full Prescribing Information for IQIRVO in the U.S.Please see full Prescribing Information for IQIRVO in the E.U. ENDS About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Nicolas Bogler | + 33 6 52 19 98 92 Media Jennifer Smith-Parker | + 44 7843 13 77 64 | jennifer.smith-parker.ext@ipsen.comRachel Reiff | + 1 908 616 1680 | rachel.reiff@ipsen.comAnna Gibbins | + 44 7717 80 19 00| anna.gibbins@ipsen.com Disclaimers and/or Forward-Looking StatementsThe forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. References 1.Kowdley. K,. et al. Long term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE® trial up to 3 years . Poster, Abstract 5041. American Association for the Study of Liver Disease (AASLD).20242.Swain. M, et al. Impact of elafibranor on fatigue in patients with primary biliary cholangitis: Interim results from the long-term open-label extension of the ELATIVE® trial . Poster, Abstract 5042. American Association for the Study of Liver Disease (AASLD).20243Lu M, Zhou, et al. Fibrotic Liver Disease Consortium Investigators. Increasing Prevalence of Primary Biliary Cholangitis and Reduced Mortality With Treatment. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1342-1350.e1. DOI: 10.1016/j.cgh.2017.12.033. Attachment Ipsen PR_Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years_15112024

Clinical ResultPhase 3Breakthrough TherapyDrug ApprovalAccelerated Approval

13 Nov 2024

·www.globenewswire.com

GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024

PBC program (licensed to Ipsen): Ipsen to present new data on elafibranor at The Liver Meeting® 2024Launch of Iqirvo® (elafibranor)1 on track with expectations; encouraging feedback from healthcare providers and payers in the U.S.UK NICE reimbursement approved and first reimbursed sales in Germany in October 2024Next €26.5M milestone payment by Ipsen pending a third pricing and reimbursement approval in Europe Scientific progress in ACLF to be featured at The Liver Meeting® 2024, with 4 posters presenting new preclinical data, and 3 events bringing together key ACLF stakeholders Results from UNVEIL-IT® Phase 2 trial evaluating VS-01 in ACLF now expected in 2H25; protocol modified to improve recruitment and trial design New insights and emerging scientific trends incorporated into our ACLF development plan, with data readout from 4 clinical trials anticipated by the end of 2025, including data from 3 new clinical trials to be launched in 1H25, in addition to UNVEIL-IT® Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 13, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today provided a corporate update ahead of The Liver Meeting 2024®2. Pascal Prigent, CEO of GENFIT said: “We are thrilled to see that Ipsen continues to execute as planned and make great progress with elafibranor, on both commercial and regulatory fronts in the U.S. and Europe, further enhancing our financial outlook for the rest of this year and beyond. We continue to build on our momentum in Acute on-Chronic Liver Failure (ACLF), where we plan to initiate multiple clinical studies in 2025 and report Phase 2 UNVEIL-IT® data from our VS-01 program. We recently updated the Phase 2 UNVEIL-IT® study protocol to improve trial enrollment and worked with centers to address logistical hurdles associated with the use of new technology. We are very confident that with these changes, along with supporting several exciting initiatives that will help better identify patients that are particularly at risk, we have taken the right steps to put GENFIT in a strong position to advance this program forward for patients.” I. Positive momentum for the Primary Biliary Cholangitis (PBC) program Ipsen recently reported positive commercial and regulatory developments with Iqirvo®3 in the U.S. and Europe 4 5: U.S. launch progress is on-track after June 10, 2024 U.S. Food and Drug Administration approval following priority review6Ipsen received EMA7 approval on September 20, 2024 and the UK MHRA8 approval on October 9, 2024 followed by UK NICE9 approval on October 22, 2024 Recent reimbursement in Germany and the UK brings GENFIT closer to a €26.5M milestone payment, pending a third pricing and reimbursement approval in a major European country II. Strategic developments across the ACLF franchise GENFIT at The Liver Meeting 2024 GENFIT will present pre-clinical data as part of its ACLF franchise with the following posters: VS-01: Effect of VS-01 on Acute-on-Chronic Liver failure-related toxins such as lipopolysaccharide and hydrophobic bile acids in vitro (poster #1603)SRT-015: Intravenous administration with the ASK1 inhibitor SRT-015 alleviates liver injury and systemic inflammation in disease models of liver failure (poster #1597)CLM-022: Investigational drug CLM-022, a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis, as a potential treatment for acute and chronic inflammatory liver diseases (poster #2232)NTZ: Efficacy of Nitazoxanide (NTZ) in Pathogen-Associated Molecular Patterns (PAMPs)-induced disease models (poster #2222) GENFIT will also lead 3 key events on ACLF: ACLF KOL Advisory Board (November 14, 2024), bringing together 9 leading experts from Europe and the United StatesACLF Patient Advocacy Council (November 16, 2024), with the participation of Professor Debbie Shawcross, MBBS PhD FRCP, Professor of Hepatology and Chronic Liver Failure, Institute of Liver Studies King’s College London, UK and EASL Vice-Secretary), the Global Liver Institute (GLI), the European Liver Patients’ Association (ELPA), and real-life patients and caregiversACLF Morning Insights session (November 17, 2024), focused on addressing unmet needs, diagnostics, and guidelines for ACLF, with Dr. Jasmohan Bajaj, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University and Richmond VA Medical Center in Richmond, Virginia, USA. The event will also offer an intensivist’s perspective with Dr. William Bernal, Professor of Liver Critical Care Medicine in the Liver Intensive Therapy Unit at the Institute of Liver Studies at King’s College Hospital, London and Member of the EASL-CLIF Consortium Steering Committee. It will also outline GENFIT’s clinical roadmap and highlight the patient and caregiver experience, via GLI and ELPA. Key strategic insights and emerging trends uncovered through unique sources and channels Over the last 12 months, GENFIT has made strides in understanding the ACLF continuum, enriching our body of knowledge compared to the knowledge available in the field at the time of our pivot to ACLF. Key takeaways derived from these workstreams will inform the design of on-going and upcoming trials evaluating VS-01, NTZ and SRT-015. These insights will also help further strategize the research and clinical development of CLM-022 and VS-02-HE. UNVEIL-IT®3 clinical and operational improvements: As announced in September 202410, lower than expected trial enrollment prompted a protocol amendment to better accommodate patient care logistics and comorbidities. These recent modifications require time before they can be implemented in every investigational site and before they can significantly impact the enrollment curve. Therefore, we are now guiding 2H25 for UNVEIL-IT results. The two main points of focus for our improvement efforts have been: Inclusion and exclusion criteria were overly restrictive for a patient population with multiple co-morbidities. As we accumulated data to better characterize these patients, we collaborated with investigators and KOLs to modify the protocol and better address the targeted population. Logistical challenges are inherent to the introduction of any new technology. In the case of VS-01 the necessary steps in the reconstitution process, and the limitation of a clinical trial setting, had previously restricted patient enrollment windows. By generating additional stability data, we now offer enhanced storage flexibility for study material, enabling clinical trial centers to use VS-01 more frequently. Additionally, we have been working on the development of an innovative medical device which should be available next year and will further streamline the reconstitution process. Cutting-edge processing of Real-World Evidence: An in-depth analysis of medical claims data – leveraged through advanced A.I. and machine learning techniques from a targeted U.S. population of over 270,000 patients – provided pivotal insights into risk profiles within specific patient sub-populations of the ACLF continuum, as well as differences in referral dynamics, patient journeys and clinical management practices compared to Europe. Applying sophisticated algorithms uncovered epidemiological patterns and trends within this substantial dataset, generating actionable intelligence that enhances our understanding and supports more precise, data-driven decisions across our portfolio.Preclinical research: New preclinical models have been established with leading experts, serving as key enablers to deliver valuable data aimed at improving our understanding of our portfolio potential. To date, the data already generated encompasses a range of disease models and various formulations. This approach is designed to optimize asset positioning and refine population targeting, ultimately supporting strategic decision-making and maximizing impact across our therapeutic landscape. Collaboration with learned societies: Strategic partnerships, including with the European Foundation for the Study of Chronic Liver Failure (EF CLIF) and engagement with U.S. KOLs from NACSELD11, offered important insights through unique data sources encompassing several observational studies, while also accelerating and expanding discussions with key leaders in the field. This type of collaboration places GENFIT at the forefront of international research, advancing the understanding of ACLF pathophysiology and uncovering novel approaches for the treatment of this syndrome. Data readout from 4 clinical trials anticipated by the end of 2025 Building on insights from the upcoming KOL Advisory Board and additional real-world evidence anticipated by late November 2024, GENFIT will finalize the design of two new proof-of-concept studies evaluating VS-01 and NTZ, alongside a First-in-Human study for SRT-015 with GENFIT’s formulation. These trials are expected to launch in the first half of 2025, with data readouts expected by year-end. With Phase 2 data for UNVEIL-IT trial also anticipated by the close of 2025, GENFIT will deliver four clinical data sets in 2025, advancing three clinical-stage assets of our ACLF pipeline in parallel. Preclinical assets CLM-022: Preclinical Proof of Concept expected to be obtained by end of 2024VS-02-HE: Completion of Investigational New Drug (IND) enabling studies expected in 2025 III. GNS561 in KRAS-mutated cholangiocarcinoma The phase 1b/2a clinical trial is currently ongoing and preliminary data from Phase 1b is targeted by the end of 2024. Final data is expected by the end of 2025. IV. NIS2+® in MASH During The Liver Meeting 2024, GENFIT will also present new data on NIS2+®’s3 efficacy as a monitoring tool for patients with MASH12 with the following posters: NIS2+, an effective monitoring tool for tracking disease evolution in patients with fibrotic MASH (poster #2062)NIS2+, an effective tool for monitoring MASH resolution and fibrosis improvement in patients with at-risk MASH (poster #2063)Detecting MASH resolution and fibrosis improvement with NIS2+ in patients with at-risk MASH (poster #2067) Significant progress has been made since the recognition of NIS2+ as a key tool for detecting at-risk MASH in June 202413, as our technology is now also covering screening and monitoring needs, and not just diagnostics needs. With more than 20 clinical MASH trials using our technology, more publications are referring to it, highlighting the relevance of our solution. In March 2024, Rezdiffra™ (resmetirom) was the first drug approved in MASH in the United States. As a reminder, GENFIT signed a commercial agreement with Labcorp in 2021 to provide broad clinical availability of the test to specialty and primary care physicians across the U.S. and Canada. Our business goal is now to develop an IVD version of the test, either in collaboration with a commercial partner or by ourselves. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about ability to receive upcoming milestone payments from Ipsen pursuant to our Licensing and Collaboration agreement and the effect of Ipsen commercial performance on our financial outlook, availability and timing of results of our UNVEIL-IT clinical trial in ACLF as well as four additional clinical programs, and the impact of changes to the UNVEIL-IT clinical trial protocol on improving trial enrollment and the timing and impact of development of a new medical device for VS-01 reconstitution. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2023 Universal Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com GENFIT | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Elafibranor is marketed and commercialized by Ipsen under the trademark Iqirvo®2 The Liver Meeting 2024® is a registered trademark of the American Association for the Study of Liver Diseases3 Iqirvo®, NIS2+® and UNVEIL-IT® are registered trademarks of GENFIT SA4 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf5 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf6 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf7 European Medicines Agency8 Medicines and Healthcare products Regulatory Agency9 UK National Institute for Health and Care Excellence10 https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-half-year-2024-financial-results-and11 North American Consortium for the Study of End-Stage Liver Disease12 Metabolic dysfunction-associated steatohepatitis13 https://ir.genfit.com/news-releases/news-release-details/genfit-new-easl-easd-easo-clinical-practice-guidelines-masld Attachment GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024

Phase 2License out/inDrug Approval

12 Nov 2024

·endpts.com

Intercept is denied full FDA approval for Ocaliva, but claims it will keep drug on market

The FDA rejected the full approval submission for Intercept Pharmaceuticals and Alfasigma’s primary biliary cholangitis treatment Ocaliva after safety concerns dogged the product, casting its future into doubt. While Intercept said it plans to keep selling Ocaliva and is talking with the FDA about next steps, most drugs that fail confirmatory trials and are rejected for full approval face a request by regulators to pull themselves off the market. The FDA did not immediately respond when asked whether that request has been made. Some companies fight those asks, which can lead to protracted legal battles. But the FDA almost always wins, eventually. Ocaliva won accelerated approval in 2016 as a second-line treatment for PBC, an autoimmune condition that impacts the bile ducts and disproportionately affects women. A black box warning was added two years later after it was being incorrectly dosed, and the FDA said in 2020 that it was investigating the risk of liver disorder. Italian pharma Alfasigma acquired Intercept for $800 million in September 2023. Debate over full approval of Ocaliva came to a head in September, when FDA advisory committee members voted resoundingly against granting full approval and said that the benefits of the drug didn’t outweigh its risks. At the center of the full approval debate was a confirmatory trial that failed and showed an increased risk of disease progression or death in patients getting the drug, according to the FDA. Intercept tried to offset safety concerns by referring to real-world observational data, but regulators and advisors were unswayed, and said the data weren’t enough to validate full approval. Intercept said Ocaliva will remain on the US market under accelerated approval. Regulators are continuing to review safety data from the confirmatory trial, the company said. Intercept US president and chairman Vivek Devaraj expressed commitment to the asset, saying in a statement that the company believes in the “totality of evidence supporting Ocaliva and intend[s] to work closely with the FDA on next steps.” “This isn’t a question of a failed trial, but a failed drug,” Yale assistant professor and health services researcher Reshma Ramachandran said. “So it’s imperative the FDA uses its authority to act and protect patients.” The commercial prospects for the drug are bleaker in Europe, after regulators pulled conditional marketing authorization ahead of the FDA advisory meeting. The rejection is a boost to Gilead and Ipsen , both of which snagged accelerated approval for their PBC candidates earlier this year. Gilead acquired the rights to its drug through its $4.3 billion acquisition of CymaBay Therapeutics earlier this year, while Ipsen licensed elafibranor (marketed as Iqirvo) from Genfit for $136 million upfront in 2021. That deal gave Ipsen access to most markets except select countries in East Asia. Zachary Brennan contributed reporting.

AcquisitionAccelerated ApprovalDrug Approval

100 Deals associated with Elafibranor

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KEGG	Wiki	ATC	Drug Bank
D11208	Elafibranor	-	DB05187

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Biliary Cholangitis	US	Ipsen Biopharmaceuticals, Inc.	10 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Biliary Cholangitis	NDA/BLA	US	Genfit SA	07 Dec 2023
Nonalcoholic Steatohepatitis	Preclinical	CO	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	ES	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	PR	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	NL	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	SE	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	CZ	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	RU	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	CA	Genfit SA	01 Mar 2016
Nonalcoholic Steatohepatitis	Preclinical	AR	Genfit SA	01 Mar 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04526665 (ELATIVE, CTgov)	Phase 3	Primary Biliary Cholangitis	161	Placebo	cmlafozgsa(maaoyuvede) = avzlgpwfzx wdyccclluk (lxoiepvkeb, fugpbjjcsj - tjypfvkkjo) View more	-	05 Sep 2024
NCT04526665 (FDA_CDER) Manual	Phase 3	Primary Biliary Cholangitis	161	IQIRVO 80mg Once Daily	(tkjlzjqbpa) = bhzmevbcmq pdlzeptqav (rvekxhrfbx ) View more	Positive	10 Jun 2024
				Placebo	(tkjlzjqbpa) = qgakoymzrd pdlzeptqav (rvekxhrfbx ) View more
NCT04526665 (ELATIVE, EASL2024) Manual	Phase 3	Primary Biliary Cholangitis	161	Elafibranor	(fzzwymguxq) = ulpamkdoym ltytuffhjt (lzxxgmsyzf ) View more	Positive	01 Jun 2024
				Placebo	(zavgbuywyn) = xdcajsxgrs ytgussgbrx (yraanrgtmv )
NCT04526665 (ELATIVE, Pubmed) Manual	Phase 3	Primary Biliary Cholangitis	161	Elafibranor 80 mg	lwfqndlzus(pvtkzkqpfc) = urbugfwzgs lwghwlfigw (itlnwqsmtx ) View more	Positive	29 Feb 2024
				Placebo	lwfqndlzus(pvtkzkqpfc) = tiqjldeosu lwghwlfigw (itlnwqsmtx ) View more
ELATIVE (NEWS) Manual	Phase 3	Primary Biliary Cholangitis	161	elafibranor	jjwaixcklf(sxyfepwfqh): differences = 3.0 View more	Positive	14 Nov 2023
				placebo
NCT04526665 (ELATIVE, Biospace) Manual	Phase 3	Primary Biliary Cholangitis	161	elafibranor 80mg	(nbsvzirqxl) = pnpyzybqku ivlefqlodg (jgmfkcrcbi )	Positive	20 Sep 2023
				placebo	(nbsvzirqxl) = efpxmjpzkk ivlefqlodg (jgmfkcrcbi )
NCT03883607 (Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis, Pubmed \| J Pediatr Gastroenterol Nutr)	Phase 2	Nonalcoholic Steatohepatitis alanine aminotransferase (ALT)	-	Elafibranor 80 mg	efksyqbpun(puymwpvktk) = mjszkhqjxm ilqduopkmx (exuniapzon, 13)	Positive	01 Aug 2023
				Elafibranor 120 mg	efksyqbpun(puymwpvktk) = qrsznofclx ilqduopkmx (exuniapzon, 20)
NCT01694849 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	275	GFT505 80mg (GFT505 80mg)	eaqdsgpbzd(veqbuszkot) = lwhcuyxoie xbzxyotvnz (lunlnpatcf, cappizfnpw - ogjihuxdmu) View more	-	03 Nov 2022
				GFT505 120mg (GFT505 120mg)	eaqdsgpbzd(veqbuszkot) = qluxyexrwg xbzxyotvnz (lunlnpatcf, zptkprjhkd - oyuomzonlj) View more
NCT02704403 (RESOLVE-IT Phase 3 \| ###DELETE \| RESOLVE-IT, CTgov)	Phase 3	Nonalcoholic Steatohepatitis \| Fibrosis	2,157	Elafibranor (120 mg Elafibranor)	vntrokjtuq(nzswgzxjht) = gepgmwfiud kxwziehfvc (eyablowpub, gbgydhhrsm - fqjysvedtp) View more	-	23 Mar 2022
				Placebo (Placebo)	vntrokjtuq(nzswgzxjht) = cwgzxudhti kxwziehfvc (eyablowpub, xjzihipsux - pgvxkaqfwn) View more
NCT03883607 (Open Label, Randomized, Multicenter Study of Elafibranor in Children With Nonalcoholic Steatohepatitis, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	10	Elafibranor 80mg (Elafibranor 80 mg)	rdqrragkfd(bxmmgdnhmf) = svnhjhnvhu qtlvaymgpc (fvodcuukgt, roilenikmn - sakuvalhme) View more	-	28 Oct 2021
				Elafibranor 120mg (Elafibranor 120 mg)	rdqrragkfd(bxmmgdnhmf) = lgwctdbowb qtlvaymgpc (fvodcuukgt, rdjdzuxvbd - quuubljqwf) View more

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