During exercise, working muscles require more oxygen. The heart meets this demand in two ways: by beating faster (heart rate) and by pumping more blood with each beat (stroke volume). Heart rate increases steadily with exercise intensity until exhaustion, but the amount of blood pumped with each beat tends to plateau at moderate intensities. Why the amount of blood pumped with each beat becomes limited before heart rate, however, is not well understood.
Studying these mechanisms is difficult because most drugs that lower heart rate also affect how strongly the heart pumps, making it hard to separate the two effects. One medication that can help with this is ivabradine, which is used to treat people with heart disease who have high resting heart rates. It slows the heart rate without changing how strongly the heart pumps.
This study will investigate whether ivabradine lowers heart rate during exercise in healthy younger and older adults, and whether a higher dose lowers heart rate more. The results will help us better understand how heart rate influences the heart's ability to supply oxygen to the body during exercise, and what limits the ability to exercise as people age.
Participants will:
* Attend three visits at SportsCardiologyBC in Vancouver
* Complete a cycling exercise test at each visit to measure heart rate and how hard they can exercise
* Take ivabradine (a heart-rate-lowering medication) before the exercise test at Visits 2 and 3 (a lower dose at Visit 2 and a higher dose at Visit 3)
* Be monitored for side effects including slow heart rate, visual symptoms, and headache.

Start Date01 Aug 2026

Sponsor / Collaborator

University of British Columbia

NCT07797946

/ Not yet recruitingNot ApplicableIIT

Comparison of Two Preoperative Ivabradin Regimens for Hemodynamic Stability During Functional Endoscopic Sinus Surgery

This study compares two different preoperative doses of a heart-rate-lowering medication called ivabradine in patients undergoing endoscopic sinus surgery under general anesthesia. Patients will receive either a lower dose, a higher dose, or a placebo (inactive pill) before surgery. The goal is to see which approach best keeps blood pressure and heart rate stable during surgery, and whether it reduces bleeding and improves the surge

Start Date01 Aug 2026

Sponsor / Collaborator

Minia University

100 Clinical Results associated with Ivabradine Hydrochloride

100 Translational Medicine associated with Ivabradine Hydrochloride

100 Patents (Medical) associated with Ivabradine Hydrochloride

1,907

Literatures (Medical) associated with Ivabradine Hydrochloride

01 Sep 2026·EXPERIMENTAL EYE RESEARCH

Retinal ON- and OFF-pathway dysfunction due to HCN channel inhibition evaluated using dark and light adapted flicker electroretinograms in rats

Article

Author: Umeya, Naohisa ; Usui, Toru ; Miyawaki, Izuru

Hyperpolarization-activated cyclic nucleotide-gated (HCN) channel inhibitors that induce visual abnormalities such as phosphenes in humans are believed to disrupt the feedback mechanisms of retinal photoreceptor cells and cause dysfunction of the ON and OFF pathways in the retina. However, this hypothesis is based mainly on studies using HCN channel-knockout mice. In this study, we evaluated whether the retinal ON and OFF pathway defects could be detected in animals treated with HCN channel inhibitors by dark-adapted and light-adapted flicker electroretinography (ERG). Ivabradine, an HCN channel inhibitor, was administered subcutaneously to Long-Evans rats at 4-40 mg/kg as a single dose, and dark- and light-adapted flicker ERGs were measured at frequencies ranging from 1 to 30 Hz. In dark-adapted flicker ERGs, waveforms including rod photoreceptor components in the low frequency range and rod ON pathway and cone ON and OFF pathway components in the intermediate- and high-frequency range were changed, and the amplitude of the waveforms were attenuated. These inhibitions of cone ON and OFF pathways were considered, based on the results of the light-adapted flicker ERGs, to have been influenced by interference with rod-driven signals via gap junctions. This study is the first report to demonstrate inhibition of ON and OFF pathway signaling in animals treated with an HCN channel inhibitor. Our findings also suggest that dark- and light-adapted flicker ERGs across a range of frequencies may be a useful tool for detecting retinal dysfunction caused by compounds inducing visual abnormalities.

01 Aug 2026·ANNALS OF PHARMACOTHERAPY

Ivabradine Use for Arrhythmias in Children

Article

Author: Stephens, Katy S. ; Behere, Shashank ; Miller, Jamie L. ; Foote, David ; Le, Monica ; Johnson, Peter N.

Background::

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that has an off-label indication for arrhythmias in pediatric patients.

Objectives::

The primary objective was identification of the line of therapy and type of arrhythmia for which ivabradine was initiated. The secondary objective was to evaluate the initial and peak ivabradine doses, tolerance in partially fed patients (i.e., patients not receiving full feeds at the time of ivabradine initiation), number of patients continued home on ivabradine, concomitant drug interactions with a class C, D, or X classification, and adverse effects.

Methods::

A retrospective study of hospitalized patients <18 years of age receiving ivabradine for arrhythmias between January 1, 2021 and November 30, 2023. Data variables included demographics, ivabradine dosing regimens, concomitant anti-arrhythmic medications, percentage of ivabradine course while receiving full enteral feeds, concomitant medications with drug-drug interactions, and adverse effects (bradycardia [defined as <100 beats/min in neonates and <50 beats/min in infants and children], atrial fibrillation, vision changes, and emesis attributed to ivabradine).

Results::

Seventeen patients were included. The most frequent arrhythmia indication was atrial tachycardia and ivabradine was most frequently used as a third-line anti-arrhythmic. Ten (58.8%) received ivabradine despite not being on full enteral feeds. The median initial and peak ivabradine doses were 0.05 mg/kg/dose and 0.07 mg/kg/dose, respectively, and it was most frequently administered every 12 hours. Only 1 patient required a dose decrease for a noted adverse effect. Most patients (94.1%) had a Class C drug-drug interaction, and 3 had a Class X interaction. Ten (58.8%) were discharged home on ivabradine.

Conclusions and relevance::

Ivabradine was safe and effective as additive therapy for the treatment of pediatric arrhythmias. Larger studies of ivabradine use in pediatric arrhythmias are needed.

01 Aug 2026·JACC. Case reports

Ivabradine in a Neonate With Severe Hypertrophic Cardiomyopathy

Article

Author: Guerrier, Karine ; Martinez, Hugo R ; Baxter, Genevieve ; Ryan, Kaitlin ; Karikari, Yaa S

BACKGROUND:

Hypertrophic cardiomyopathy (HCM) affects approximately 20% of patients with Noonan syndrome and contributes significantly to mortality, particularly in neonates with severe HCM and left ventricular outflow tract obstruction, where controlling heart rate (HR) and maintaining systemic vascular resistance can be challenging.

CASE SUMMARY:

A full-term neonate with an Raf-1 proto-oncogene, serine/threonine kinase mutation and severe HCM developed diastolic heart failure requiring high-dose esmolol for rate control and phenylephrine for systemic vascular resistance support. After inadequate HR response and associated vasodilation due to esmolol, off-label ivabradine was started at 20 days of life, achieving HR control within 48 hours and allowing weaning of vasoactive agents and respiratory support.

DISCUSSION:

Standard therapies-β-blockers, nondihydropyridine calcium channel blockers, and sodium-channel blockers-can worsen left ventricular outflow tract obstruction. Ivabradine selectively inhibits the I(f) current via hyperpolarization-activated cyclic nucleotide-gated channel 4 in sinoatrial tissue, providing HR reduction without compromising contractility or hemodynamics.

TAKE-HOME MESSAGE:

Ivabradine provides durable HR control without negative inotropy or hypotension, supporting its use in symptomatic pediatric HCM.

News (Medical) associated with Ivabradine Hydrochloride

28 Jul 2026

·www.businesswire.com

Shionogi Announces U.S. Availability of XOCOVA ® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure*

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced U.S. availability of XOCOVA® (ensitrelvir), an oral antiviral, approved for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.2 XOCOVA offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset.4,5 XOCOVA is taken once daily, with three 125 mg tablets (375 mg) taken at the same time on the first day, followed by one 125 mg tablet on days two through five. XOCOVA should be taken as soon as possible and within 72 hours following contact with an individual who has COVID‑19.1 “With XOCOVA, we have a novel oral option to help prevent COVID-19 after exposure, and it is available just in time for the annual late summer spike,” said Charles Vega, MD, FAAFP, Health Sciences Clinical Professor, University of California, Irvine, School of Medicine. “Taking XOCOVA to help prevent COVID-19 in the critical window between exposure and symptom onset makes sense for anyone who wants to try to avoid illness, and it could be especially beneficial for older adults and individuals with health conditions that may put them at higher risk for severe illness. Now, in addition to recommending my patients stay updated with vaccinations, I’ll be talking to them about XOCOVA, so they are ready to act quickly in the event of an exposure.” The U.S. has experienced a COVID-19 summer spike every year since 2020.3 Biobot Analytics, a wastewater intelligence company with continuous and longitudinal data on pathogens from wastewater, reports that SARS-CoV-2 levels are beginning to rise, providing an early, population-level signal that another COVID-19 summer wave may be taking shape.6 Scenario modeling from The U.S. Centers for Disease Control and Prevention indicates there may be increased COVID-19 activity in regions (South and West) which did not experience a substantial level of COVID-19 activity during the most recent fall and winter months.3 “Post-exposure prophylaxis, or PEP for short, has been used successfully with influenza as well as HIV and other sexually transmitted infections, and it has the potential to help reduce the burden of COVID-19,” said David Wohl, MD, Professor of Medicine, The University of North Carolina at Chapel Hill, School of Medicine. “The availability of XOCOVA means that now, for the first time, there’s an oral option that can help prevent COVID-19 after exposure. Since XOCOVA must be taken within 72 hours of exposure, having it on hand can help ensure it is taken within the critical window between exposure and COVID-19 symptom onset.” Having XOCOVA on hand can help appropriate patients be prepared in the event of a COVID-19 exposure. Before taking XOCOVA, individuals should review the dosing and administration instructions and check the expiration date on the blister pack. They should also speak with a healthcare professional if there are any changes to their medications (including prescription and over-the-counter medicines), vitamins or supplements and verify they are not pregnant or breastfeeding. Shionogi is supporting the availability of XOCOVA through professional and consumer education and partnerships with national and regional pharmacies to ensure product availability. Select retail pharmacies across the U.S. will have XOCOVA in stock, and all retail pharmacies can order it from Shionogi’s wholesale distribution partners. Shionogi has a commercial co-pay offer for XOCOVA that helps eligible, commercially insured patients with out-of-pocket costs. Eligible patients may pay as little as $0 per prescription fill. Details about eligibility are available at https://www.xocova.com/. All components of XOCOVA are produced in the U.S. including active pharmaceutical ingredient production, drug product formulation, packaging, quality control, release testing, and supply chain and distribution. The Ongoing Impact of COVID-19 COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.7 The U.S. Centers for Disease Control and Prevention estimates that between October 1, 2025, and July 11, 2026, there were 4.2-12.7 million new cases in the U.S., resulting in 840,000 – 2.3 million outpatient visits, 130,000 – 250,000 hospitalizations and 14,000 - 42,000 deaths.8 Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and chronic kidney conditions during the year following infection.9-,10,11,12,13,14,15,16,17,18 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities.19 About SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study was conducted from June 2023–September 2024. It included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline. More than 98% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both.20 Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on Day 1 and 125 mg on Days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued XOCOVA (125 mg) or placebo for five days. In the primary analysis population, XOCOVA significantly reduced the risk of symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011).2 The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough.1 There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial.2,20 Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual. About XOCOVA XOCOVA® (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S. and Japan for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 in adults and adolescents 12 years of age and older based on results from SCORPIO-SR, a Phase 3 study conducted in Asia during the Omicron-dominant phase of the pandemic. Results from this study were published in JAMA Network Open. XOCOVA received supplemental approval in June 2026 in Japan for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. XOCOVA is not approved for the treatment of COVID-19 in the U.S. INDICATION XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12. IMPORTANT SAFETY INFORMATION Do not take XOCOVA if you are: allergic to ensitrelvir or any of the ingredients in XOCOVA. take any of the following medicines, as these may interact with XOCOVA and may cause severe or life-threatening side effects or death: apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John’s wort, simvastatin, triazolam or voclosporin. These are not the only medicines that may cause serious or life-threatening side effects if taken with XOCOVA. XOCOVA may increase or decrease the levels of many medicines in your body. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines. Before taking XOCOVA, tell your HCP about all your medical conditions, including if you: are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use. are breastfeeding or plan to breastfeed. It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP. What are the possible side effects of XOCOVA? XOCOVA may cause serious side effects, including: Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking XOCOVA and get medical help right away if you get any of the following allergic reaction symptoms: skin rash; hives; itching; swelling of the mouth, lips, tongue, or face; trouble swallowing or breathing; throat tightness; dizziness or feeling lightheaded; stomach-area (abdomen) pain; or vomiting. The most common side effects of XOCOVA include: headache, diarrhea, and cough. These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Patient Information, for XOCOVA. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company committed to bringing to market the best possible medicines to aid the health and well-being of the patients we serve. Our global expertise in infectious disease began in the 1950s and in addition to discovering and developing multiple innovative antibiotics, today our global portfolio includes an antibiotic for the treatment of serious Gram‑negative bacterial infections, antivirals for COVID-19, HIV and influenza and a therapeutic for rare fungal infections. Our U.S. infectious disease franchise includes both approved and investigational novel anti-infectives, and investigational antivirals for COVID-19 and RSV. In parallel, we are advancing a U.S. rare disease franchise that includes an approved therapy for amyotrophic lateral sclerosis (ALS), along with clinical programs in Fragile X syndrome, Jordan’s syndrome, and Pompe disease. We are also pursuing research in additional high‑unmet need therapeutic areas, including oncology, acute ischemic stroke, sleep apnea, and other quality of life areas. Learn more at shionogi.com. About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. *Literature search conducted in May 2026 1 XOCOVA (ensitrelvir) Prescribing Information. Available from: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/xocova.pdf. Accessed July 6, 2026. 2 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. N Engl J Med. 2026;394(19):1905-1915. doi:10.1056/NEJMoa2509306. 3 Centers for Disease Control and Prevention [Internet]. 2026 COVID-19 Summer Outlook. 2026. Available from: https://www.cdc.gov/cfa-qualitative-assessments/php/data-research/2026covid-19outlook.html 4 Kawashima S, Matsui Y, et al. Ensitrelvir is effective against SARS-CoV-2 3CL protease mutants circulating globally. Biochem Biophys Res Commun. 2023;645:132-136. doi:10.1016/j.bbrc.2023.01.040. 5 Kuroda T, Nobori H, et al. Efficacy comparison of 3CL protease inhibitors ensitrelvir and nirmatrelvir against SARS-CoV-2 in vitro and in vivo. J Antimicrob Chemother. 2023;78(4):946-952. doi:10.1093/jac/dkad027. 6 Donnelly M [Internet]. Respiratory risk report: week ending in July 4, 2026. Biobot Analytics; 2026. Available from: https://biobotanalytics.substack.com/p/respiratory-risk-report-663 7 Tanaka M, Ruiz C, et al. SARS-CoV-2 transmission dynamics in households with children, Los Angeles, California. Front Pediatr. 2021;9:752993. doi:10.3389/fped.2021.752993. 8 Centers for Disease Control and Prevention [Internet]. Preliminary estimates of COVID-19 burden for 2024-2025. 2026. Available from: https://www.cdc.gov/covid/php/surveillance/burden-estimates.html 9 Centers for Disease Control and Prevention [Internet]. Long COVID basics. 2026. Available from: https://www.cdc.gov/long-covid/about/index.html. 10 Xie Y, Xu E, et al. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3. 11 Xie Y, Xu E, et al. Risks of mental health outcomes in people with COVID-19: a cohort study. BMJ. 2022;376:e068993. doi:10.1136/bmj-2021-068993. 12 Srivastava S, Garg I. Post-COVID-19 infection: long-term effects on liver and kidneys. World J Meta-Anal. 2021;9(3):220-233. doi:10.13105/wjma.v9.i3.220. 13 Tenforde MW, Kim SS, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health care systems network— United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-998. doi:10.15585/mmwr.mm6930e1. 14 Graham EL, Clark JR, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized COVID-19 “long haulers.” Ann Clin Transl Neurol. 2021;8(5):1073-1085. doi:10.1002/acn3.51350. 15 Kwok WC, Chau CH, et al. Outcomes among patients with chronic obstructive pulmonary disease after recovery from COVID-19 infection of different severity. Sci Rep. 2024;14(1):13881. doi:10.1038/s41598-024-64670-9. 16 Conway SE, Healy BC, et al. COVID-19 severity is associated with worsened neurological outcomes in multiple sclerosis and related disorders. Mult Scler Relat Disord. 2022;63:103946. doi:10.1016/j.msard.2022.103946. 17 Chen IW, Chang LC, et al. Association between COVID-19 and the development of chronic kidney disease in patients without initial acute kidney injury. Sci Rep. 2025;15(1):10924. doi:10.1038/s41598-025-96032-4. 18 Sax PE, Draica F, et al. New onset conditions, exacerbations and worsening of underlying conditions following COVID-19 infection [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 19 Gravenstein S, Cooke C, et al. Current impact of COVID-19 in long-term care facilities in the United States: a systematic literature review [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 20 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. Supplementary Appendix. N Engl J Med. 2026;394(19). Available from: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2509306/suppl_file/nejmoa2509306_appendix.pdf.

Phase 3Clinical ResultDrug Approval

08 Jul 2026

·www.biospace.com

Amgen recalls almost 1 million bottles of heart failure drug over quality issue

Anamarija Mrkic /Getty Images The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy. Amgen has recalled almost 1 million bottles of its chronic heart failure drug Corlanor in response to a contamination concern. The FDA attributed Amgen’s action to the presence of a foreign substance. Amgen began the voluntary recall of 934,577 bottles of the 5-mg Corlanor tablets last month. The recalled products are a mix of 14- and 60-tablet bottles of Corlanor. Amgen also recalled an undisclosed number of bottles of 7.5-mg tablets. Expiry dates for the recalled 5- and 7.5-mg tablets range from July 2026 to December 2028. California-based Amgen listed Italy as the country where the medicines were made. The company has international manufacturing facilities in Ireland, the Netherlands and Singapore, but it also works with third-party contract manufacturers. The FDA categorized the action as a Class II recall, indicating that the drug may cause temporary health consequences but the probability of a serious health issue is small. The recall notice lacks information about whether adverse events are linked to the recalled products. Manufacturing FDA rejects Unicycive and Sobi filings over contract manufacturing deficiencies Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners. June 30, 2026 · 2 min read · Nick Paul Taylor Read more Amgen won FDA approval for Corlanor in 2015. The drug, which Amgen licensed from Servier, reduces the spontaneous pacemaker activity of the cardiac sinus node to slow the patient’s heart rate. In doing so, Corlanor cuts the risk of hospitalization for worsening heart failure. Corlanor represents a minor revenue stream for Amgen. In its first-quarter results, Amgen grouped the medicine with 12 other drugs that generated sales of $315 million collectively. Corlanor was too small a product even early in its lifecycle to have its own line on Amgen’s financial results. The FDA shared details of the Corlanor recall alongside information about issues with another Amgen drug, Sensipar. Amgen has recalled 9,565 bottles of the chronic kidney disease (CKD) drug made in Japan over deviations from current good manufacturing practices. The FDA approved Sensipar in 2004, clearing the drug for use in treating secondary hyperparathyroidism in CKD patients on dialysis. Sensipar is among the products that Amgen grouped with Corlanor in its first-quarter results. The drug, which Amgen sells as Mimpara in Europe, was once among the company’s best-selling products. Sensipar sales exceeded $1 billion in 2013 and peaked close to $1.8 billion in 2018, only to decline significantly after generic copies came to market.

Drug ApprovalAccelerated Approval

06 Jul 2026

·www.fiercepharma.com

Amgen issues recall for close to 1M heart med bottles due to contamination

Amgen has issued a voluntary recall for nearly 1 million bottles of the heart medication Corlanor (ivabradine) due to possible contamination. The nationwide recall was issued by the company on June 4 and was classified by the FDA as a Class II recall on June 23. Amgen took action after a possible foreign substance was discovered, according to FDA records. Two separate notices concerning the action were issued by the regulatory agency, with one citing 934,577 5-mg bottles of Corlanor in 14-tablet and 60-tablet containers. The company also issued a recall for an undisclosed number of 7.5 mg 60-count bottles . All the recalled heart pills were produced in Italy. The drug is typically used to treat chronic heart failure in adults and for children 6 months or older experiencing stable heart failure symptoms caused by an enlarged heart. The company also initiated a nationwide recall of 9,565 bottles of 30-mg, 30-count bottles of Sensipar (cinacalcet), used to treat hyperparathyroidism in dialysis patients and high blood calcium that can be triggered by parathyroid cancer or severe primary hyperparathyroidism. The California drugmaker also issued recalls due to manufacturing deviations for an undisclosed number of 90-mg , 30-count bottles and 60-mg , 30-count bottles of Sensipar, which the FDA has classified as a Class II action. The recalled Sensipar tablets were all manufactured in Japan, and the dates for those recalls posted on the agency’s website are the same as for Corlanor. The recalls fell at the same time Amgen got bad news that European Union regulators recommended its ANCA-associated vasculitis drug Tavneos lose its authorization in the wake of a review that found the drug’s benefits were “no longer proven to outweigh its risks.” A final decision by the European Commission was expected to be handed down soon. Amgen is also bracing for an FDA hearing to address efficacy and safety concerns regarding Tavneos.

100 Deals associated with Ivabradine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D08095	Ivabradine Hydrochloride	C01EB17	DB09083

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Reduced ejection fraction co-occurrent and due to chronic heart failure	Australia	Pharmacor Pty Ltd.	16 Jul 2026
Angina Pectoris	China	Les Laboratoires Servier SAS	29 Apr 2015
Heart Failure	United States	Amgen, Inc.	15 Apr 2015
Angina, Stable	European Union	Les Laboratoires Servier SAS	25 Oct 2005
Angina, Stable	Iceland	Les Laboratoires Servier SAS	25 Oct 2005
Angina, Stable	Liechtenstein	Les Laboratoires Servier SAS	25 Oct 2005
Angina, Stable	Norway	Les Laboratoires Servier SAS	25 Oct 2005
Chronic heart failure	European Union	Les Laboratoires Servier SAS	25 Oct 2005
Chronic heart failure	Iceland	Les Laboratoires Servier SAS	25 Oct 2005
Chronic heart failure	Liechtenstein	Les Laboratoires Servier SAS	25 Oct 2005
Chronic heart failure	Norway	Les Laboratoires Servier SAS	25 Oct 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Postural Orthostatic Tachycardia Syndrome	Phase 3	United States	Amgen, Inc.	06 Feb 2018
Plaque, Atherosclerotic	Phase 3	Belgium	Institut Servier de Medecine Translationnelle SARL	11 Apr 2013
Coronary Artery Disease	Phase 3	United Kingdom	Institut de Recherches Intern Servier	01 Dec 2004
Left ventricular systolic dysfunction	Phase 3	United Kingdom	Institut de Recherches Intern Servier	01 Dec 2004
Neuralgia	Phase 2	United Kingdom	Les Laboratoires Servier SAS	14 Apr 2014
Endothelial dysfunction	Phase 2	United Kingdom	Institut Servier de Medecine Translationnelle SARL	22 Jul 2013
Heart Failure, Diastolic	Phase 2	Austria	Institut Servier de Medecine Translationnelle SARL	17 Jul 2013
Cardiomyopathy, Dilated	Phase 2	Belgium	Institut Servier de Medecine Translationnelle SARL	20 Oct 2011
Ischemia	Phase 2	Italy	Institut Servier de Medecine Translationnelle SARL	26 Sep 2011
Myocardial Stunning	Phase 2	Italy	Institut Servier de Medecine Translationnelle SARL	26 Sep 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06305780 (RECOVER-AUTONOMIC, CTgov)	Phase 2	Post Acute COVID 19 Syndrome \| Autonomic Nervous System Diseases	381	Ivabradine Placebo + Usual Care+Ivabradine + Usual Care (Ivabradine)	lkptddmeto = mviiztohyw otfonyvzrt (wiowpbhelu, stphgzrvla - gtjoacaiuo) View more	-	03 Aug 2026
				IVIG Placebo + Usual Care (Intravenous Immunoglobulin (IVIG))	cuzlptcbvr(flunpximvq) = gevjvxufbu wucowajudp (julqcdonnj, qpfdbnqmbv - uotfppafbe) View more
NCT06305806 \| NCT06305780 \| NCT06305793 (RECOVER-AUTONOMIC, Pubmed \| Am Heart J)	Phase 2	Postural Orthostatic Tachycardia Syndrome	203	IVIG or ivabradine with matching placebo (coordinated nonpharmacologic care)	aewsdzfomy(zyyoentjbz) = cfilbzrgah zgfxhioels (phwecxjivt )	Positive	01 Jun 2026
NCT05279651 (Pubmed \| Circulation)	Phase 3	-	2,101	Ivabradine 5 mg	xosisymdlx(hhvjiuakik) = lmwddeihft znqahpsnwc (yjbqxfbgxr )	Negative	21 Oct 2025
				Placebo	xosisymdlx(hhvjiuakik) = nygvuiubij znqahpsnwc (yjbqxfbgxr )
NCT03168529 (OBSERVE-IVA, CTgov)	Phase 4	Heart Failure	19	Ivabradine (Ivabradine (Corlanor))	zbuiyozwrb(xuwmmtnsdo) = wvgehirkzf mgvdvjmgnv (cziaaxklen, rskaouzooq - cjherpjqfn) View more	-	08 Jun 2025
				Placebo (Placebo)	zbuiyozwrb(xuwmmtnsdo) = ypowdspdwz mgvdvjmgnv (cziaaxklen, hvougynehb - nezcdecqhx) View more
NCT03650205 (Pubmed \| J Am Heart Assoc)	Not Applicable	Cardiotoxicity \| Neoplasms \| Heart Failure	107	Ivabradine 5 mg twice daily	kololhjobo(gszawxdkdm) = orynhaohjf cxligdtoss (cijjknxkqk ) View more	Negative	20 May 2025
				Placebo	kololhjobo(gszawxdkdm) = hcopuxuhzw cxligdtoss (cijjknxkqk ) View more
NEWS Manual	Not Applicable	Heart Failure	656	“新四联”+伊伐布雷定	qbupfllbev(gwpamqyuhu) = mnpaawekol foiohdvhcs (vmtubhsujn ) View more	Positive	16 Jan 2025
				“新四联”+未使用伊伐布雷定	qbupfllbev(gwpamqyuhu) = gzlibrvwww foiohdvhcs (vmtubhsujn ) View more
NCT04436016 (Pubmed)	Phase 4	high-sensitive cardiac troponin T elevation	78	Ivabradine 2.5 mg	bcqamxwzpz(esbrpcomxx) = oixagvwfeh nbxrviknzs (zngffpolqm ) View more	Positive	01 Jul 2024
				Ivabradine 5.0 mg	bcqamxwzpz(esbrpcomxx) = ttswutjcnh nbxrviknzs (zngffpolqm ) View more
NCT03137537 (CTgov)	Phase 2	Heart Failure	23	Ivabradine (Ivabradine)	xyuudrisvm(hbyqvmikbh) = xisueajctl kcimzbgqja (hgyhwdpsmd, doxxeqxaym - ukihygxekn) View more	-	10 Feb 2022
				Placebo Oral Tablet (Placebo Oral Tablet)	xyuudrisvm(hbyqvmikbh) = hlbnnlrriy kcimzbgqja (hgyhwdpsmd, clooccdxjk - cvcatolskb) View more
POSITIVE study (ESC2021)	Not Applicable	Chronic heart failure	1,003	Ivabradine	pdrrmgfmwq(tcauwcyvhz) = vntngukget xsmjscjwdn (anzzxukxnm )	Positive	29 Jun 2021
NCT03182725 (POTS, CTgov)	Phase 3	Postural Orthostatic Tachycardia Syndrome	37	Placebo (Placebo)	bptyfneyss(zwelhtpmea) = jnyubzwolp zrjdzojzor (qdfmrvxxyb, 10.4) View more	-	29 Jun 2021
				Ivabradine (Ivabradine)	bptyfneyss(zwelhtpmea) = uwpeviwhuc zrjdzojzor (qdfmrvxxyb, 8.6) View more

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