本试验旨在研究单次空腹和餐后口服山东新华制药股份有限公司研制、生产的苯巴比妥片（30 mg）的药代动力学特征；以Fujinaga pharm Co.,Ltd.持证、藤永製薬株式会社生产的苯巴比妥片（Phenobal®，30 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-72，评价两制剂的人体生物等效性。

[Translation]

This trial aims to study the pharmacokinetic characteristics of phenobarbital tablets (30 mg) developed and produced by Shandong Xinhua Pharmaceutical Co., Ltd. after a single fasting and postprandial oral administration; Fujinaga Pharm Co., Ltd., licensed by Fujinaga Phenobarbital tablets (Phenobal®, 30 mg) produced by Seiko Co., Ltd. are used as reference preparations. The pharmacokinetic parameters Cmax and AUC0-72 of the two preparations are compared to evaluate the human bioequivalence of the two preparations.

Start Date28 Jul 2024

Sponsor / Collaborator

Shandong Xinhua Pharmaceutical Co., Ltd.

CTR20230764 / CompletedNot Applicable

苯巴比妥片（30mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、平行设计生物等效性试验

[Translation] A randomized, open-label, single-dose, parallel-design bioequivalence study of phenobarbital tablets (30 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Fujinaga pharm Co.,Ltd.持证的苯巴比妥片（商品名：Phenobal®，规格：30mg/片）为参比制剂，对精华制药集团股份有限公司生产的受试制剂苯巴比妥片（规格：30mg/片）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Fujinaga pharm Co., Ltd.'s certified phenobarbital tablets (trade name: Phenobal®, specification: 30 mg/tablet) were selected as the reference preparation, and the test preparation phenobarbital tablets (specification: 30 mg/tablet) produced by Jinghua Pharmaceutical Group Co., Ltd. were tested for fasting and postprandial human bioequivalence, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Start Date12 Apr 2023

Sponsor / Collaborator

Jinghua Pharmaceutical Group Co., Ltd.

CTRI/2023/02/049794 / Not yet recruitingNot ApplicableIIT

Phenobarbitone versus Levetiracetam as 1st line therapy for Neonatal Seizures- A Randomized Control Trial

Start Date28 Feb 2023

Sponsor / Collaborator-

100 Clinical Results associated with Phenobarbital

100 Translational Medicine associated with Phenobarbital

100 Patents (Medical) associated with Phenobarbital

20,849

Literatures (Medical) associated with Phenobarbital

01 Dec 2024·PEDIATRIC NEUROLOGY

A Comparison of Treatment Practices for Newborn Seizure Management Across Level II and III Neonatal Intensive Care Units in the United States

Article

Author: Carrasco, Melisa ; Keene, Jennifer C ; Morgan, Lindsey A ; Natarajan, Niranjana ; Morgan, Lindsey A. ; Dickman, Jacky A ; Keene, Jennifer C. ; Dickman, Jacky A.

BACKGROUND:

Neonatal seizures (NS) represent an important clinical manifestation among critically ill infants and are often the first sign of underlying brain injury. Early recognition and treatment are essential to reduce morbidity and mortality. The present study investigated the NS management and treatment approaches employed by level II/III neonatal intensive care units (NICUs) across the United States to identify areas of consensus and variability.

METHODS:

Personnel associated with level II/III NICUs were directly surveyed with an electronic questionnaire. Access to neurology specialists, on-site electroencephalography (EEG) monitoring, and use of antiseizure medications was directly queried. A total of 51 NICUs participated in this survey.

RESULTS:

Twenty-five percent of the surveyed NICUs reported having an established clinical practice pathway available for treating NS. Twenty-four percent endorsed having written guidelines that provided a formal definition for the concept of "neonatal seizures." Although the majority of NICUs reported having phenobarbital available for rapid seizure management, most NICUs lacked access to additional antiseizure medications for treatment escalation. Twenty-four percent of the surveyed NICUs had no access to EEG monitoring available to them on-site. Daytime and overnight access to neurology consultants was limited and variable.

CONCLUSIONS:

Findings were consistent with a lack of equitable access for NS treatment. Areas of potential improvement include development and implementation of a protocol for rapidly treating NS that emphasizes enhanced access to EEG and rapid neurology consultation, acknowledging and improving upon resource limitations. These developments may eventually provide earlier detection, evaluation, and treatment of seizures in newborns, contributing to improved long-term outcomes.

01 Dec 2024·The Annals of pharmacotherapy

Evaluation of Clinical Outcomes Associated With Phenobarbital With Taper Compared to No Taper for the Management of Alcohol Withdrawal Syndrome

Article

Author: Yankama, Tuyen ; Eche, Ifeoma Mary ; Thaller, Matthew ; Elsamadisi, Pansy ; Wong, Adrian

Background::

Phenobarbital (PHB) has been shown to be an effective treatment of alcohol withdrawal syndrome (AWS), with multiple dosing strategies used (e.g., single-dose and symptom-triggered). Studies have often used tapered doses, typically following a front-loaded dose, despite PHB’s long half-life which should lead to an ability to auto-taper.

Objective::

The purpose of this study was to compare clinical outcomes associated with two PHB dosing strategies (taper [T], no taper [NT]) for AWS.

Methods::

This retrospective cohort study compared adult patients admitted to the ICU from October 2017 to May 2019 who received an initial loading dose of PHB for AWS. The use of PHB was at the discretion of the clinician per our institutional guidelines. Prior to November 2018, patients were prescribed a PHB taper, while after this period, the taper was no longer recommended. The primary outcome was the proportion of patients requiring rescue PHB or adjunctive medications for AWS. Secondary outcomes included number of adjunctive agents used, prevalence of severe manifestations of AWS, ICU and hospital lengths of stay, and incidence of potentially significant drug interactions.

Results::

A total of 172 patients were included (T: n = 81, NT: n = 91). Baseline characteristics were similar between groups, including history of severe AWS and cumulative benzodiazepine dose pre-PHB. There was no difference in the primary outcome between groups (T: 70.4% vs NT: 59.3%, P = 0.152). The median number of adjunctive agents per patient, severe manifestations, and ICU and hospital length of stay did not differ between groups. Twenty-five patients (14.5%) had potentially significant drug interactions.

Conclusion and Relevance::

The use of a PHB loading dose without a taper may be comparable to a taper strategy on clinical outcomes. Prospective studies are needed to further delineate the optimal dose of PHB for AWS.

01 Dec 2024·Probiotics and antimicrobial proteins

Evaluation of Four Multispecies Probiotic Cocktails in a Human Colonic Fermentation Model

Article

Author: Douny, Caroline ; Bondue, Pauline ; Thonart, Philippe ; Gonza, Irma ; Druart, Germain ; Al-Chihab, Mohamed ; Goya-Jorge, Elizabeth ; Delcenserie, Véronique ; Boutaleb, Samiha ; Scippo, Marie-Louise

Bacteriotherapy represents an attractive approach for both prophylaxis and treatment of human diseases. However, combining probiotic bacteria in "cocktails" is underexplored, despite its potential as an alternative multi-target therapy. Herein, three-strain probiotic mixtures containing different combinations of Bacillus (Bc.) coagulans [ATB-BCS-042], Levilactobacillus (Lv.) brevis [THT 0303101], Lacticaseibacillus (Lc.) paracasei [THT 031901], Bacillus subtilis subsp. natto [ATB-BSN-049], Enterococcus faecium [ATB-EFM-030], and Bifidobacterium (Bf.) animalis subsp. lactis [THT 010802] were prepared. Four cocktails (PA: Bc. coagulans + Lv. brevis + Lc. paracasei, PB: Bc. subtilis subsp. natto + Lv. brevis + Lc. paracasei, PC: E. faecium + Lv. brevis + Lc. paracasei, PD: Bc. coagulans + Lv. brevis + Bf. animalis subsp. lactis) were tested using a short-term (72 h) simulation of the human colonic microbiota in a final dose of 6 × 10⁹ CFU. All these probiotic mixtures significantly increased butyrate production compared to the parallel control experiment. PA and PB promoted a bifidogenic effect and facilitated lactobacilli colonization. Furthermore, reporter gene assays using the AhR_HT29-Lucia cell line revealed that fermentation supernatants from PA and PB notably induced AhR transactivity. Subsequent examination of the metabolic outputs of PA and PB in intestinal epithelial models using cell culture inserts suggested no significant impact on the transepithelial electrical resistance (TEER). Assessment of the expression of proinflammatory and anti-inflammatory cytokines, as well as AhR-related target genes in the Caco-2 cell monolayers indicated that PB's metabolic output upregulated most of the measured endpoints. This in vitro investigation evaluated the potential impact of four multispecies probiotic mixtures in the human colonic microbiota and identified a promising formulation comprising a combination of Bc. subtilis subsp. natto, Lv. brevis, and Lc. paracasei as a promising formulation for further study.

News (Medical) associated with Phenobarbital

22 Oct 2024

·www.biospace.com

Gilead to Present Latest Research Across Key Liver Disease Indication at the American Association for the Study of Liver Disease (AASLD) Meeting 2024

- Key Insights from Viral Hepatitis, PBC, and MASH/Fibrosis Studies Highlight Gilead’s Ongoing Commitment to Advancing Life-Changing Liver Disease Research - FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new research to be presented at The Liver Meeting ® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego, Calif. More than 40 abstracts will be presented with key data, including 11 abstracts reporting new data on primary biliary cholangitis (PBC). The data will include findings from the RESPONSE trial that demonstrate the efficacy and safety pro Livdelzi ® (seladelpar) in people living with PBC and compensated cirrhosis. Additionally, data will be presented on the effects of Livdelzi on pruritus (chronic itching), a symptom that has significant impact on the quality of life of people living with PBC, along with interim long-term efficacy and safety results from the ongoing ASSURE study. Beyond PBC, Gilead will be presenting an interim analysis of the Phase 3 MYR301 study, which is evaluating people living with hepatitis Delta virus (HDV) who received bulevirtide monotherapy (2 mg for 144 weeks; 10 mg for 144 weeks; or 10 mg for 96 weeks) for chronic HDV and have been off treatment for 48 weeks. The study is evaluating whether or not patients treated with bulevirtide monotherapy for 2-3 years maintained virological and biochemical responses one year after stopping treatment. An additional 144-week analysis of patient-reported outcomes for individuals treated with bulevirtide 2 mg will also be presented, adding to the wealth of long-term data for the treatment for chronic HDV. “We’re excited to share our latest research at The Liver Meeting, as we push the boundaries of what’s possible in liver disease treatment. The breadth of this research reflects Gilead’s unwavering dedication to advancing life-changing science and shaping healthier futures for people living with liver disease,” said Anu Osinusi, Vice President of Clinical Development for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “The depth and range of our data, spanning both viral and inflammatory liver diseases, underscores our commitment to making a meaningful impact at every stage of a person’s journey in liver disease. Our goals go far beyond treatment alone—our work spans awareness, education, screening, diagnosis, and long-term care, all intending to address unmet needs and enhance treatment outcomes.” Gilead will also present hepatitis C virus (HCV) data which will include safety and tolerability outcomes for Epclusa ® (velpatasvir/sofosbuvir) in pregnant individuals with chronic HCV (the STORC study). As a special population that is often excluded from clinical research, these results may help clinicians better support pregnant people living with HCV, which in turn may reduce the risk of transmission to infants. Furthermore, real-world findings from the SVR10K study on HCV will be showcased, demonstrating the effects of direct-acting antivirals against all HCV genotypes across diverse regions. Late-breaking data from a Phase 2a open-label study assessing the safety and efficacy of novel combination therapies for chronic hepatitis B virus (HBV) will also be presented by Gilead. Key Abstracts at AASLD 2024: ID Abstract Title PBC 164 Efficacy and Safety of Seladelpar in Patients with PBC and Compensated Cirrhosis in the Phase 3 Placebo-controlled RESPONSE Trial 167 Attenuation, Near Resolution, and Prevention of Pruritis in Patients with PBC Treated with Seladelpar: A Secondary Analysis of Patterns of Pruritis Change in the RESPONSE Trial 4339 Alkaline Phosphatase Changes with Seladelpar Across Subgroups of Primary Biliary Cholangitis Patients in the RESPONSE Trial 4342 Seladelpar and Reductions in Lipids in Patients with Primary Biliary Cholangitis with and without Statin use in the Phase 3 Placebo-controlled RESPONSE Study 4341 Long-term Safety of Seladelpar 10 mg with up to 5 Years of Treatment in Patients with Primary Biliary Cholangitis Primary sclerosing cholangitis (PSC) 151 Associations Between Biomarkers and Magnetic Resonance Imaging-derived ANALI Score in Patients with Primary Sclerosing Cholangitis: Analysis from the Phase 3 PRIMIS Study HDV 1147 Efficacy and Safety of BLV Monotherapy for Chronic Hepatitis Delta: Post Treatment Results through 48 Weeks after the End of Treatment from an Interim Analysis of a Randomized Phase 3 Study MYR301 1193 Patient-reported Outcomes among Patients with Chronic Hepatitis Delta Treated with Bulevirtide 2 mg: A Long-term Analysis of the Phase 3 MYR301 Trial at 144 Weeks 139 Long-term Bulevirtide Monotherapy in Patients with HDV-related Compensated Cirrhosis: Effectiveness, Safety and Clinical Outcomes from the Retrospective Multicenter European Study (SAVE-D) HCV 222 Safety, Tolerability, and Outcomes of Velpatasvir/Sofosbuvir in Treatment of Chronic Hepatitis C Virus during Pregnancy (STORC) 1455 The SVR10K Study: A Real-world Data with Pangenotypic Direct-acting Antivirals across Multiple Diverse Regions 1476 Hepatitis C Treatment Uptake Differs by Gender among a Commercially Insured Population in the United States HBV 1380 Results from a Phase 2a, Open-label Study to Evaluate the Safety and Efficacy of Novel Combination Therapies Containing VIR-2218, Selgantolimod, and Nivolumab for the Treatment of Chronic Hepatitis B 1252 Effectiveness and Safety of Tenofovir Alafenamide in Chronic Hepatitis B Patients with Suboptimal Response to Antiviral Therapy 1337 Characterization of Changes in Noninvasive Fibrosis Markers over 8 Years of Tenofovir-based Treatment in Chronic Hepatitis B Patients Enrolled in Two Phase 3 Trials Nonalcoholic steatohepatitis (NASH)/Fibrosis 1520 Prospective Validation of the Mediterranean Diet Adherence Screener (MEDAS) for Point-of-care Assessment of Diet Quality in Patients with Metabolic Dysfunction-associated Steatotic Liver Disease For more information, including a complete list of abstract titles being presented at the meeting, please visit the AASLD website . In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide’s conditional MA license in Great Britain was converted to a full MA in August 2023 and a full MA was granted in Switzerland and Australia in 2024. In regions where it is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and has not been approved anywhere. Cilofexor and selgantolimod are investigational compounds and are not approved by the FDA or any other regulatory authority; their safety and efficacy have not been established. Please see below for the U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Livdelzi. U.S. Important Safety Information And Indication for EPCLUSA BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. Contraindications If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information. Warnings and Precautions Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4 : Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations. Adverse Reactions The most common adverse reactions (≥10%, all grades) with EPCLUSA in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug. Drug Interactions Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan. Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir. Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments. Indication EPCLUSA is indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. U.S. Important Safety Information for LIVDELZI Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. Indication LIVDELZI is 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. This indication is approved under accelerated approval based on a reduction of 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 Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). About HDV HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with HBV. On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people who have a chronic infection with HBV are estimated to have HDV, equating to 12-15 million people worldwide. The prevalence of HDV infection is largely underestimated due to lack of universal testing of HBV-positive individuals for HDV. About PBC PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT), enzymes found primarily in the liver, as well as total bilirubin. The most common symptoms of PBC are pruritus and fatigue, which can be debilitating for some people. Progression of PBC is associated with an increased risk of liver-related mortality. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Epclusa, Hepcludex (bulevirtide), Livdelzi (seladelpar), cilofexor and selgantolimod (such as the ASSURE, RESPONSE, MYR301, STORC and SVR10K studies); uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of investigational programs for indications that are currently under evaluation and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Epclusa, Hepcludex, Livdelzi, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Contacts Meaghan Smith, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

Phase 2Clinical ResultDrug ApprovalPhase 3

16 Oct 2024

·www.businesswire.com

ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024 , being held in Los Angeles, California from 16 – 19 October. Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option. Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.” Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real world with zero cases of HIV acquisition during follow-up 1 New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024. Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection. OPERA study highlights high adherence and effectiveness of CAB LA for PrEP 2 Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic. CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case. Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety 3 New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino. The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV. While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections. CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence. These studies demonstrate ViiV Healthcare's commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use. APRETUDE (cabotegravir) extended-release injectable suspension P rofessional Indication and Important Safety Information INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS Do not use APRETUDE in individuals: with unknown or positive HIV-1 status with previous hypersensitivity reaction to cabotegravir receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs) Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE Potential Risk of Resistance with APRETUDE: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE Long-Acting Properties and Potential Associated Risks with APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated Depressive Disorders: Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE Promptly evaluate patients with depressive symptoms Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. DRUG INTERACTIONS Refer to the full Prescribing Information for important drug interactions with APRETUDE Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir USE IN SPECIFIC POPULATIONS Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation Pediatrics: Not recommended in individuals weighing less than 35 kg About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1. M Ramgopal, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis: Data from Trio Health cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024, 16-19 October, Los Angeles, CA. 2. R Hsu, et al. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024. 3. H. Holder, et al. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024.

Clinical ResultPhase 3

01 Oct 2024

·www.amgen.com

LA LA ANTHONY PARTNERS WITH AMGEN TO SHARE CANDID, BEHIND-THE-SCENES LOOK AT HOW PLAQUE PSORIASIS AFFECTS HER LIFE

Campaign Encourages Open Dialogue With Doctor About Unmanaged Symptoms to Find the Right Treatment Option THOUSAND OAKS, Calif. , Oct. 1, 2024 /PRNewswire/ -- Amgen (NASDAQ: AMGN) has partnered with multi-talented actress, producer and entrepreneur La La Anthony to share her personal journey living with plaque psoriasis, and to inspire people to be open with their doctors about how the disease affects their daily lives. As one of the more than 6 million people in the United States living with plaque psoriasis, La La understands the frustrations of living with this disease. Symptoms can distract from everyday moments, big and small, even influencing clothing or makeup choices. 1,2 Experience the full interactive Multichannel News Release here: https://www2.multivu.com/amgen/9292951-en-la-la-anthony-amgen-partner-to-encourage-open-dialogue-about-plaque-psoriasis In a new interactive video , La La offers an intimate, behind-the-scenes look at how plaque psoriasis has affected her personal and professional life – and her realization of how important it is to advocate for treatment options that work well for her, and to help others do the same. "I have spent so much time and energy trying different methods to manage my plaque psoriasis that were often messy or inconvenient to apply, like a prescription shampoo for my scalp psoriasis. It required daily hair washing, which is not practical for my hair," said La La. "I was hesitant to tell my doctor that some treatments didn't work with my lifestyle, but I realized that doctors can only help if they know the full picture. I want to encourage people living with plaque psoriasis to be vocal about how the disease and treatments are impacting their daily lives." Although common, plaque psoriasis is a frequently misunderstood disease. Many people think it is a skin condition, but it is an autoimmune disease that starts as inflammation inside the body. 1 The inflammation presents as itchy, flaky patches that may cover large portions of the skin or only a few areas. 1 Research shows that people with plaque psoriasis and their doctors aren't always on the same page about how severe their condition is – with patients believing their symptoms to be more severe than their doctor's assessment. 3 Many people are prescribed topical treatments for plaque psoriasis patches, like creams or ointments. While these topical medications may provide relief, they are only treating the symptoms of the disease – not a root cause of inflammation – and are often viewed by patients as messy to apply. 4-7 "Plaque psoriasis is a chronic inflammatory condition and each patient's experience is unique," said board-certified dermatologist Meagen McCusker M.D ., M.S., FAAD. "The good news is advances in the field have given us a multitude of treatment options. For many patients who struggle with topical therapies, or who feel like their symptoms are not well managed by their current routine, I suggest talking to your doctor about a treatment option that helps reduce the underlying inflammation. Disease severity and lifestyle are key factors that influence a patient's choice for treatment – there is no one-size-fits all approach." To interact with La La in her new video, access resources to help facilitate an open conversation about plaque psoriasis treatment with your doctor and learn about Otezla ® (apremilast), an oral treatment option, visit MomentsWithLaLa.com . La La is not currently on treatment or taking Otezla. Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. For more information, please visit Otezla.com . About Psoriasis Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin. 1 Approximately 125 million people worldwide have psoriasis, including more than 8 million people in the United States . 8,9 About 80% of those patients have plaque psoriasis. 2 About Otezla ® (apremilast) Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 1 million patients worldwide. INDICATIONS Otezla ® (apremilast) is indicated for the treatment of: IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions Adverse Reactions Use in Specific Populations Please click here for the full Prescribing Information for Otezla. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads . Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen , Thousand Oaks Elissa Snook , 609-251-1407 (media) Breen Weir , 415-535-9814 (media) Justin Claeys , 805-313-9775 (investors) References ### View original content: https://www.prnewswire.com/news-releases/la-la-anthony-partners-with-amgen-to-share-candid-behind-the-scenes-look-at-how-plaque-psoriasis-affects-her-life-302263339.html SOURCE Amgen

Drug ApprovalAcquisition

100 Deals associated with Phenobarbital

External Link

KEGG	Wiki	ATC	Drug Bank
D00506	-	N03AA02	DB01174

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	JP	Fujinaga Pharm Co. Ltd.	09 Aug 1948
Sedation	JP	Fujinaga Pharm Co. Ltd.	01 Jul 1948
Seizures	JP	Fujinaga Pharm Co. Ltd.	01 Jul 1948

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2024	Not Applicable	-	204	Phenobarbital	opihjtcddl(aupnclddaw) = dmhanqlbfv keizxrvcew (yxffpfgwhb ) View more	Negative	19 May 2024
				Lorazepam	opihjtcddl(aupnclddaw) = rmlycasznq keizxrvcew (yxffpfgwhb ) View more
ATS2023	Not Applicable	Alagille Syndrome	-	Phenobarbital	ozpfoqxifh(xbayvpwlyr) = gylvpnncae eivyrhhepp (yietermidh ) View more	-	21 May 2023
				Lorazepam	pyylmnbiar(dpqeswhfwo) = btvzntgkou mmpzisdnza (htrmrpzson ) View more
ATS2023	Not Applicable	Alcohol Abstinence	-	Benzodiazepines alone	gjlfcguxbo(dixtnjuofv) = ofpirftpmb hjgywzdity (bspartqxlv ) View more	-	21 May 2023
				Benzodiazepines + Phenobarbital	gjlfcguxbo(dixtnjuofv) = tqjozjyhkj hjgywzdity (bspartqxlv ) View more
ATS2023	Not Applicable	Substance Withdrawal Syndrome	-	Phenobarbital-based protocol	ytwmkoikol(hiohhmphud) = uvqyivialk tnvowhyrqo (wwuqbyyjep ) View more	-	21 May 2023
				Benzodiazepine-based protocol	ytwmkoikol(hiohhmphud) = xkokejuegl tnvowhyrqo (wwuqbyyjep ) View more
NCT03670160 (CTgov)	Phase 2	Neonatal Abstinence Syndrome	25	Phenobarbital (Phenobarbital)	ayyqstubki(ekwwnioqyx) = mmxkdgempx zobnkqjyjr (leqeybjnnb, tslwqclans - htonmueiye) View more	-	09 Nov 2021
				Clonidine (Clonidine)	ayyqstubki(ekwwnioqyx) = msdoltqzwa zobnkqjyjr (leqeybjnnb, iyctvgutwm - phdrrpafnn) View more
NCT02810782 (Pubmed)	Phase 3	Neonatal Abstinence Syndrome	143	Morphine	dbjafjrjat(fjmevqwcts) = qrzionnqgq yjevihmfhh (hcpbbhwtgu, 18 - 33)	-	01 Jan 2020
				Phenobarbital	dbjafjrjat(fjmevqwcts) = hgdpymklne yjevihmfhh (hcpbbhwtgu, 27 - 38)
NCT01958476 (CTgov)	Phase 3	Neonatal Abstinence Syndrome	117	Methadone+Phenobarbital (Methadone)	ektqpvfmvx(tyvkqoezai) = haqtwwhtgp saieoslhyy (pzetguigyn, yxgocuzohf - gymvwytpmi) View more	-	15 Oct 2019
				Neonatal Morphine Solution+Phenobarbital (Neonatal Morphine Solution)	ektqpvfmvx(tyvkqoezai) = rtvbkyzgiv saieoslhyy (pzetguigyn, yuuzwwlono - ebhcvledcm) View more
ANA2017	Not Applicable	-	-	Phenobarbital	pyvpmewteo(qadpjrirgo) = rhdgqblftd lnsfgshinh (fwtfdljkat )	Negative	15 Oct 2017
				Midazolam	pyvpmewteo(qadpjrirgo) = lvfhznfvat lnsfgshinh (fwtfdljkat )
NCT01089504 (PROPHENO, CTgov)	Phase 4	Epilepsy, Benign Neonatal	13	phenobarbital (Phenobarbital)	bzhgcggsef(emyqrhqfwr) = qyfpixetmc zqpswettqv (jchofimogm, sywkcvwmvb - rpdqxqvjgo) View more	-	03 Feb 2016
				placebo (Placebo)	bzhgcggsef(emyqrhqfwr) = tendukutuy zqpswettqv (jchofimogm, lusjbkwgpf - vgdysvmbqx) View more
WCN2015	Not Applicable	thyroid hormones	-	Phenobarbital	axvuokmsnp(uwthqyuula) = dclummeotc okbtbqksgf (rdnbrshwqb ) View more	-	15 Oct 2015

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