A Multi-center, Randomized, Double-Blind, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety, Efficacy and Pharmacokinetics of DFD-25 (Zileuton Ointment), 1.25% and 5%, in Subjects with Moderate to Severe Atopic Dermatitis (AD) Over a 4 Week Treatment Period

Start Date02 Dec 2019

Sponsor / Collaborator-

NCT03571620

/ CompletedPhase 2

A Multicenter, Randomized, Phase 2, Double-blind, Vehicle-controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of Q301 Cream in Adolescents and Adults With Mild to Moderate Atopic Dermatitis

This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adolescent and adult subjects with mild to moderate AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

Start Date21 Jun 2018

Sponsor / Collaborator

Qurient Co., Ltd.

NCT02348203

/ CompletedPhase 2IIT

Clinical Study of the Effect of Combined Treatment of Aspirin and Zileuton on Biomarkers of Tobacco-Related Carcinogenesis in Current Smokers

This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers.

Start Date13 Jan 2016

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Zileuton

100 Translational Medicine associated with Zileuton

100 Patents (Medical) associated with Zileuton

664

Literatures (Medical) associated with Zileuton

31 Dec 2026·CANCER BIOLOGY & THERAPY

The dual role of leukotrienes in the tumor microenvironment: balancing pro-tumorigenic and anti-tumor immunity

Review

Author: Sacco, Keith ; Fernandez-Bussy, Sebastian ; Thake, Andrew ; Caruso, Maria

BACKGROUND:

Leukotrienes are bioactive lipid mediators produced via the 5-lipoxygenase (5-LO) pathway and are essential for inflammatory signaling in the tumor microenvironment (TME), playing roles in angiogenesis, immune modulation and metastatic progression.

OBJECTIVE:

This review evaluates the role of leukotriene signaling in cancer progression and highlights biomarker-guided therapeutic strategies targeting these pathways in the TME.

METHODS:

A narrative review of preclinical, clinical, and epidemiological studies was performed, with prespecified inclusion criteria and prioritization of recent evidence.

RESULTS:

Leukotriene-mediated signaling correlates with biomarkers such as CysLT1 receptor expression, β-catenin activation, and HIF-1α signaling. In preclinical models, pharmacological agents including montelukast, zileuton, and FLAP antagonists suppress tumor growth, and restore apoptotic signaling; current clinical evidence remains largely observational and pharmacoepidemiologic.

CONCLUSION:

Targeting this pathway represents a promising avenue in oncology, with potential to enhance precision medicine through biomarker-guided patient stratification. Further clinical validation is warranted to translate these findings into therapeutic benefit.

02 Dec 2026·JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH-PART A-CURRENT ISSUES

Effect of 5-lipoxygenase protein expression in malignant breast cancer cells and mechanisms involved in tumor suppression

Article

Author: Han, Jing ; Bai, Chun-Ying

Breast cancer remains a major threat to women's health worldwide, and exploring novel therapeutic targets is urgently needed. Inhibiting 5-lipoxygenase (5-LOX) showed promising potential in treating various malignancies. However, 5-LOX effects on breast cancer progression are largely unknown. Breast cancer cell lines (MCF-7 and MDA-MB-231) and nonmalignant breast epithelial cells (MCF-10A) were used in this study. The expression of 5-LOX was quantified by RT-qPCR and Western blot analysis. 5-LOX was upregulated by pCDNA3.1(+)-5-LOX transfection and inhibited using zileuton. The influence of 5-LOX modulation on cell apoptosis, invasion, and colony formation was determined using flow cytometry, Transwell invasion assay, and colony formation assay, respectively. Results demonstrated that 5-LOX mRNA and protein expression levels were significantly higher in breast cancer cells compared with nonmalignant breast epithelial cells. Transfection with pCDNA3.1(+)-5-LOX significantly upregulated 5-LOX expression, while zileuton, an anti-inflammatory leukotriene inhibitor of 5-LOX, treatment (400 μmol/L) markedly downregulated 5-LOX mRNA and protein levels. Treatment with zileuton significantly induced apoptosis in MCF-7 and inhibited in MDA-MB-231 cell invasion. Further, zileuton suppressed colony formation in both breast cancer cell lines. Data suggest that 5-LOX may serve as a potential therapeutic target for breast cancer, and zileuton warrants further investigation as a candidate anti-cancer agent.

01 Dec 2026·Toxicology reports

Effects of lawsone and lawsone methyl ether on cyclooxygenase activity, redox balance, and organ-specific toxicity: An integrated computational and experimental study

Article

Author: Shah, Muhammad Ajmal ; Khan, Muhammad ; Ahmad, Nadeem ; Khemawoot, Phisit ; Sohail, Tehmina ; Ul-Haq, Zaheer ; Rahman, Asad Ur ; Panichayupakaranant, Pharkphoom

Redox imbalance contributes significantly to the initiation and progression of inflammatory responses. Although conventional anti-inflammatory drugs are widely used, their prolonged administration is associated with a number of adverse effects. Lawsone methyl ether (LME) and lawsone are plant-derived, redox-active naphthoquinones, exhibiting diverse pharmacological activities; however, their cyclooxygenase (COX)-inhibitory effects, redox-modulatory properties, and oral toxicity profiles remain insufficiently characterized. Therefore, this study investigated the COX-inhibitory activity, redox-modulatory effects, and oral toxicity profiles of LME and lawsone using integrated computational, enzyme-inhibitory, and in vivo approaches. Molecular docking analysis revealed favorable binding scores/interactions of LME against COX-1 (-5.9 kcal/mol), lipoxygenase (LOX; -6.6 kcal/mol), NAD(P)H oxidase (-5.6 kcal/mol), and myeloperoxidase (MPO; -4.7 kcal/mol), surpassing lawsone and reference inhibitors (aspirin, and zileuton). These results were further validated by molecular dynamics (MD) simulations. Additionally, LME exhibited higher in vitro inhibition of COX-1 (IC₅₀: 8.1 µM) and COX-2 (IC₅₀: 4.2 µM) than lawsone. Furthermore, acute (50/300 mg/kg) and subacute (50 mg/kg) oral administration of LME in Wistar rats significantly ameliorated glutathione (GSH), superoxide dismutase (SOD), catalase (CAT), and thiobarbituric acid-reactive substance (TBARS) levels, more effectively than lawsone. Following Karber's method, oral LD₅₀ values calculated for LME and lawsone were 542 and 175 mg/kg, respectively. However, in a 28-day repeated oral toxicity study, a no-observed-adverse-effect level (NOAEL) of at least 50 mg/kg was established for both the compounds, with no toxicity observed across various rat parameters. Overall, LME was better tolerated than lawsone, exhibiting COX inhibitory and redox-modulatory effects, but its therapeutic significance requires further validation.

News (Medical) associated with Zileuton

29 Apr 2026

·www.biospace.com

AI Detection and Repurposed Drugs Signal New Era in Food Allergy Research at Food Allergy Fund Summit

Food Allergy Fund Debuts Caregiver resource with Dr. Becky Kennedy, alongside breakthroughs in food allergy detection and treatment NEW YORK--(BUSINESS WIRE)-- #biotech --The Food Allergy Fund (FAF) today convened scientists, investors, policymakers, and advocates at its annual Summit in New York City, unveiling advances that mark a pivotal shift in food allergy care: from delayed detection and limited treatment options toward earlier intervention and emerging therapies. Highlights included first-of-their-kind findings on AI-powered anaphylaxis detection, progress in repurposing FDA-approved drugs as allergy treatments, and the debut of a caregiver resource developed with Dr. Becky Kennedy, clinical psychologist and founder of Good Inside. Food allergies affect 1 in 13 children and 1 in 10 adults in the United States. Every three minutes, someone is rushed to the emergency room for a severe allergic reaction—underscoring the urgency of moving discoveries from the lab into real-world care for the more than 300 million people affected worldwide. AI Enables Real-Time Detection of Anaphylaxis Diagnosing food allergies remains one of the most challenging aspects of care, requiring patients to consume a potential allergen under clinical supervision, where early signs of anaphylaxis can be subtle and time sensitive. Now, FAF has brought AI technology to anaphylaxis detection, with new FAF-funded study data at Mount Sinai showing that a child’s anaphylactic reaction could be detected in real time using smartwatch data and remotely monitored by a research team in Israel - before symptoms became clinically apparent. The study uses AI software developed by Anjo.ai. “Our algorithm shows strong preliminary results in identifying allergic reactions earlier, and we are now able to monitor these remotely in real time,” said Tal Golan, co-founder and CEO of Anjo.ai. “This marks a meaningful step forward in improving the safety and precision of high-risk allergy diagnostics—and in enhancing safety in everyday life for families managing food allergies.” Repurposed Drugs Accelerate Path to Treatment The Summit also highlighted progress in FAF’s Drug Repurposing Program, which is advancing three already FDA-approved drugs—zileuton, abrocitinib and metformin—as potential food allergy treatments. Because these drugs have existing safety pro they can move to human trials far faster than traditional drug development allows. FAF is funding the first human clinical trial of zileuton, an FDA-approved asthma drug, to determine whether targeting a newly identified immune signaling pathway in the gut can prevent anaphylaxis in people with food allergies. The trial is led by Dr. Stephanie Eisenbarth and Dr. Adam Williams at Northwestern University Feinberg School of Medicine. “We’ve found there is a diverse range of how much allergen is absorbed among different people, which may help explain why reactions vary, and suggests this drug could potentially be used ahead of time in higher-risk situations to help reduce the chance of a severe reaction,” said Dr. Eisenbarth. New Caregiver Guide Addresses the Behavioral Side of Food Allergy Progress in food allergy extends beyond the scientific. The Summit also debuted Safe Kids. Strong Voices —a free caregiver guide FAF exclusively developed with insights from Dr. Becky Kennedy, founder & CEO of Good Inside, the leading parenting platform used by millions, offering practical language to help children speak up, feel understood, and stay safe. Dr. Kennedy joined Arianna Huffington, founder and CEO of Thrive Global, for a fireside conversation on how communication and confidence shape safety and inclusion for children living with food allergies. “A parent’s number one job is to keep their kids safe - while also not taking away the chance for their child to build confidence, self-advocacy, and a real sense of capability. That balance? It’s not straightforward. It’s nuanced, and it can feel really hard, especially for parents of kids with food allergies. That's why I’m so glad to support families navigating food allergies through this guide.” Connecting a Fragmented Field The FAF Summit connects more than stakeholders, it connects a fragmented field. “Food allergy research has long been fragmented across disciplines, institutions, and sectors, and that fragmentation costs patients time,” said Ilana Golant, founder and CEO of the Food Allergy Fund. “FAF was built to be the convenor and connector this field needed, bringing together the scientists, investors, policymakers and advocates who are turning those collaborations into faster progress for patients.” Additional Summit Highlights The Summit addressed the full arc of food allergy progress—from lab to lived experience: Venture Philanthropy as a Funding Model : Leaders from Beyond Celiac, Vie Ventures, and the Crohn's & Colitis Foundation discussed how patient-driven capital and perspective are reshaping research funding. Families Driving Policy Change : Parent advocates shared how personal experience is translating into landmark legislation, including Elijah's Law, the ADDE Act, and the ADINA Act. Biotech and Translation : Leaders from Inimmune, Moonlight Therapeutics, Prota Therapeutics, and Ukko discussed next-generation approaches to prevention, immune modulation, and targeted therapy. AI, Immunology, and FAF’s New Israel Collaborative : Leaders from Technion, Tel Aviv University, and Anjo.ai explored how AI is advancing prediction, diagnosis, and treatment. Key Facts - Food allergies affect 1 in 13 children and 1 in 10 adults in the United States - 75% of children with food allergies are allergic to multiple foods - Someone is rushed to the ER for a severe reaction every 3 minutes - Nearly half of adults with food allergies developed them in adulthood - The estimated impact of food allergies is nearly $40 billion in societal costs About the Food Allergy Fund The Food Allergy Fund (FAF) is a science-driven nonprofit that serves as a granter and convener. FAF supports research to prevent, diagnose, and treat food allergies—a growing public health crisis affecting 10 percent of people in the United States and more than 300 million worldwide. FAF identifies and funds high-impact research, builds multi-sector coalitions, and works with scientists, policymakers, industry leaders, and families affected by food allergies. Through summits, partnerships, and strategic public private collaborations, FAF is transforming how food allergies are understood and addressed. Learn more at . Contacts Media Contact: Amy DiElsi, Director of Communications, press@foodallergyfund.org

09 Apr 2026

·www.globenewswire.com

Cures Within Reach Approves Five Clinical Trials at Chicago-based Research Institutions

Clinical trials are led by early-stage investigators and/or impact health equity, veterans and pediatricsFuture funding increased to offset cuts in medical research funding CHICAGO, April 09, 2026 (GLOBE NEWSWIRE) -- Cures Within Reach (CWR), a global nonprofit that identifies and funds clinical trials testing approved therapies for unsolved diseases, has approved funding for five new clinical trials led by Chicago-based research institutions to de-risk potential therapeutic options that address unsolved diseases. CWR focuses on transforming the lives of patients living with unsolved diseases with treatments that can be used in the near-term by supporting trials that de-risk and catalyze follow-on funding, build clinical evidence required for regulatory approval, or generate support for off-label use by patients everywhere. The five Chicago-based clinical trials are: Using a Wearable Leg Stimulation Device to Improve Mobility of Veterans with Parkinson’s at Edward Hines Jr VA Hospital and CARESInvestigating Zileuton to Prevent Pediatric Food Allergy Anaphylaxis at Lurie Children’s HospitalTreating PTSD in Veterans and Survivors of Violence with an ADHD Drug at University of ChicagoUsing a Chemotherapy Drug to Reduce Post-Transplant Diabetes at University of ChicagoAdding Lactulose to Immunotherapy to Improve Cancer Treatment Outcomes at University of Chicago “Our mission is to leverage the speed, safety and cost-effectiveness of testing approved therapies for unsolved diseases. With our lead funding partner in Chicago, the Searle Funds at The Chicago Community Trust, we are excited to increase our investment in both Chicago and, this year especially, in early-stage investigators (ESI) to support five new trials that are low-risk and high-reward,” said Barbara Goodman, President & CEO of Cures Within Reach. “Funding for research is difficult to obtain in the best of times, and with the commitment of the Searle Funds at The Chicago Community Trust and others across Chicago, we are accelerating our investment to find new treatments for diseases that can quickly reach the patients who need solutions, whether through regulatory approval or off-label use.” CWR has grown the number of Chicago-based trials it has selected for funding from roughly one each year just a few years ago to four or five each year. The five listed above are already underway or due to start soon. CWR has recently opened its next Request for Proposals to select more Chicago-based clinical repurposing trials by late 2026. An example of a successful clinical trial funded by CWR was conducted at the University of Chicago in 2009. CWR funded a Phase I trial proposed by then ESI Dr. Scott Eggener, along with Dr. Aytekin Oto, to repurpose a laser device used for liver cysts to treat newly diagnosed prostate cancer patients. Now, after this proof-of-concept and other follow-on trials, University of Chicago has become a global leader in this type of treatment, known as focal therapy, providing vastly improved patient outcomes. In addition, in 2026 CWR will continue to expand its support for funding ESIs (researchers who have completed their advanced degree or medical residency within the last ten years) who have been negatively impacted by the 2025 cuts in medical research funding. As a way to offset this troubling trend, Chicago-based donors have recently increased their funding for ESIs, and hope that other funders follow in their own areas of interest. “We’re very excited about the impact Cures Within Reach’s approach can have on transforming not only biomedical research but also patient’s lives,” said Nydia Searle, consultant to the Searle Funds at The Chicago Community Trust. “Cures Within Reach is enormously productive – they have the network, the pipeline, and the expertise to drive clinical results globally.” About Cures Within ReachCures Within Reach (CWR) is a US-based nonprofit leader testing already approved therapies for unsolved diseases by leveraging the speed, safety and cost-effectiveness of repurposing: driving more treatments to more patients more quickly. CWR provides seed funds for pivotal studies that, when successful, allow a catalytic effect of follow-on funding for trials that build clinical evidence for physicians to make decisions with their patients (called off-label use) or for regulatory approval. CWR's 2026 initiatives include validating AI drug-disease predictions and clinical trials impacting veterans, pediatrics and LMIC-based patients. CWR currently has a global portfolio of 52 funded trials at 39 institutions in 33 diseases in 12 countries. Visit cureswithinreach.org. Contact Research@CuresWithinReach.org for more information.

Clinical StudyPhase 1

27 Oct 2025

·www.globenewswire.com

Amneal Launches Brekiya® – the First and Only DHE Autoinjector for Adults with Migraine With or Without Aura and Cluster Headaches

Brekiya® autoinjector, a new specialty therapy from Amneal, is now available for prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the U.S. commercial launch of Brekiya® (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 The Brekiya autoinjector is now available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy. “We are excited to introduce Brekiya autoinjector, making this innovative therapy broadly available to healthcare providers and patients. As the first and only self-administered, ready-to-use DHE autoinjector, Brekiya offers patients the ability to treat debilitating attacks in a convenient way and avoid visits to the emergency room. With our expanding neurology portfolio, Amneal is committed to supporting providers through comprehensive education and ensuring strong patient access as we bring Brekiya autoinjector to market,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty. Migraine affects approximately 43 million Americans3, and about 300,000 live with cluster headache.4 Headache disorders are also the fourth most common reason for U.S. emergency department visits, accounting nearly for 3% of cases.5 There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.2 Information for Physicians and Patients: Brekiya is available only through prescription.Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors per carton), applied automatically through the specialty pharmacy.To support healthcare providers, field reimbursement specialists will be available to assist with patient access, coverage and reimbursement questions. Do not take Brekiya with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. IndicationBrekiya is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya is safe and effective in children. IMPORTANT SAFETY INFORMATIONBOXED WARNING: WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORSSerious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. Do not use Brekiya if you: are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole.have heart problems or a history of heart problems, or uncontrolled high blood pressure.have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease).have sepsis, had vascular surgery, severe liver or kidney problems.are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya.have taken any of the following medicines in the last 24 hours, before intended administration: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptan.have taken any medicines that constrict your blood vessels or raise your blood pressure. Before you take Brekiya, tell your healthcare provider about all your medical conditions, including if you: have high blood pressure, liver problems, or kidney problems.have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease.are pregnant or plan to become pregnant. Brekiya may cause preterm labor. Brekiya should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.are breastfeeding or plan to breastfeed. Brekiya may reduce breast milk supply and pass into your breast milk. Brekiya may be harmful to your baby. Do not breastfeed your baby while taking Brekiya and for 3 days after you use Brekiya. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya works. Your healthcare provider can tell you if it is safe to take Brekiya with other medicines. How should I use Brekiya autoinjector? Certain people should take their first dose of Brekiya autoinjector in their healthcare provider’s office or in another medical setting.Brekiya is for injection under the skin (subcutaneous) only.Use Brekiya exactly as your healthcare provider tells you to use it.Each autoinjector contains one dose (1 mg).If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses.Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24-hour period or 6 doses (6 mg) in a 1-week (7 day) period.Using BREKIYA for 10 or more days in 1 month may make your headache worse. What are the possible side effects of Brekiya?Brekiya can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke, such as face drooping, slurred speech and unusual weakness.Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).Stomach and intestinal problems.Increased blood pressure.Medicine overuse headache. Some people who use too much Brekiya may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya.Preterm labor.Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach.The most common but serious side effects of Brekiya are heart problems that happen but may lead to death. These heart problems include: temporary squeezing of arteries that supply the heart (coronary artery vasospasm)temporary decrease of blood flow to the heart (transient myocardial ischemia)heart rhythm problems (ventricular tachycardia and ventricular fibrillation). Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya. Call your healthcare provider for medical advice about side effects. How should I store Brekiya? Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.Protect Brekiya from light.Keep Brekiya in the original pack until ready to use. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at Brekiya.com. References: Brekiya package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.Data on File. Amneal Pharmaceuticals LLC.Cohen F, et al. Headache. 2024;64(5):516-532.Fischera M et al. Cephalalgia. 2008;28(6)614-618.Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483. Note: Brekiya is a registered trademark of Amneal Pharmaceuticals LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor ContactAnthony DiMeoVP, Investor Relationsanthony.dimeo@amneal.comMedia ContactBrandon SkopSr. Director, Corporate Communicationsbrandon.skop@amneal.com

Drug Approval

100 Deals associated with Zileuton

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KEGG	Wiki	ATC	Drug Bank
D00414	Zileuton	R	DB00744

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	United States	Chiesi USA, Inc	09 Dec 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 2	United States	Qurient Co., Ltd.	21 Jun 2018
Moderate Atopic Dermatitis	Phase 2	United States	Qurient Co., Ltd.	01 Apr 2015
Severe Atopic Dermatitis	Phase 2	United States	Qurient Co., Ltd.	01 Apr 2015
Asthma chronic	Phase 2	-	Critical Therapeutics, Inc.	01 Sep 2007
Acne Vulgaris	Phase 2	United States	Critical Therapeutics, Inc.	01 Nov 2004
Food Hypersensitivity	Preclinical	United States	Yale School of Medicine	07 Aug 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02348203 (CTgov)	Phase 2	Carcinogenesis \| Tobacco Use Disorder	63	Laboratory Biomarker Analysis+Aspirin+Zileuton (Arm I (Aspirin, Zileuton))	elcpbytgpk(ujthgqyoxn) = xoqdaxjnbw zmdzenhxiy (othcxvluqx, 2.89) View more	-	23 Mar 2020
				Laboratory Biomarker Analysis (Arm II (Double Placebo))	elcpbytgpk(ujthgqyoxn) = gtlmzgkylb zmdzenhxiy (othcxvluqx, 2.26) View more
NCT01021215 (CTgov)	Phase 1/2	Tobacco Use Disorder	84	laboratory biomarker analysis+Zileuton (Arm I: Zileuton)	eruhvbvomk(rludhjeexe) = xsodqhwbpk zdybkqewoo (bpbfekatkj, oxkbshgdwf - gxvtcrxddy) View more	-	02 Apr 2015
				laboratory biomarker analysis+celecoxib+Zileuton (Arm II: Zileuton and Celecoxib)	eruhvbvomk(rludhjeexe) = qpeyczxkfg zdybkqewoo (bpbfekatkj, dbvggvoftn - rraicxpjtg) View more
NCT01805687 (CTgov)	Phase 4	Asthma chronic	25	Zileuton extended release	puevpaphxt(zsdqvmewaw) = tqgekvdsgq ujlesfxdxt (ilgaomwuys, 0.706) View more	-	18 Aug 2014
NCT00467831 (CTgov)	Phase 1/2	Hermanski-Pudlak Syndrome \| Pulmonary Fibrosis \| Albinism With Hemorrhagic Diathesis and Pigmented Reticuloendothelial Cells	3	Pravastatin+Erythromycin+N-Acetyl Cysteine+Losartan+Zileuton	qqxwwzwpgy = biwaidgacs chnnsesrbc (lvfphgfncd, sczqcrddph - gcuspxzsbu) View more	-	02 Aug 2013
NCT00493974 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	119	Zileuton 600 mg	telsrwrzok(gmptviywsh) = mpfqmynnhx jvmpcjhaut (gfgbqgjoxw ) View more	Negative	01 Feb 2011
				Placebo	telsrwrzok(gmptviywsh) = jbeurzhdfj jvmpcjhaut (gfgbqgjoxw ) View more
NCT00493974 (LEUKO, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	119	Zileuton (Zileuton)	ppzhroqpbo(wipclwxufc) = gonzzjokxs kuqydbcbrs (rfsupnvrgt, 2.19) View more	-	03 Mar 2010
				Placebo (Placebo)	ppzhroqpbo(wipclwxufc) = jphferwvxs kuqydbcbrs (rfsupnvrgt, 3.06) View more
NCT00575861 (Pubmed \| Pulm Pharmacol Ther)	Phase 4	Moderate persistent asthma Add-on	22	Fluticasone 250μg/Salmeterol 50μg	bnsrjmwgoe(sqdrgxaulx) = wctjuqimow vjatalxoig (cflvrrrsuk ) View more	-	01 Dec 2009
				Fluticasone 250μg/Salmeterol 50μg + Zileuton 600mg	bnsrjmwgoe(sqdrgxaulx) = qfhkbxpvqh vjatalxoig (cflvrrrsuk ) View more

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