This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Start Date31 Dec 2026

Sponsor / Collaborator

Sclnow Biotechnology Co., Ltd.

TCTR20260225007

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, full replicated crossover design with four-period, two-treatment, and two-sequence of Ezetimibe and Atorvastatin 10/40 mg film-coated tablets relative to ATOZET (10 MG/40 MG) in healthy Thai participants under fasting condition

Start Date22 Jun 2026

Sponsor / Collaborator

Bio-innova Co., Ltd

NCT07474649

/ Not yet recruitingPhase 3

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Start Date01 Jun 2026

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

100 Clinical Results associated with Atorvastatin Calcium

100 Translational Medicine associated with Atorvastatin Calcium

100 Patents (Medical) associated with Atorvastatin Calcium

8,274

Literatures (Medical) associated with Atorvastatin Calcium

01 Mar 2026·AMERICAN JOURNAL OF HYPERTENSION

High-Intensity Atorvastatin and 24-Hour Blood Pressure in Obstructive Sleep Apnea: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Article

Author: Karim, Shahid ; Wright, R Scott ; Somers, Virend K ; Vungarala, Soumya ; Covassin, Naima ; Bock, Joshua M ; Singh, Prachi ; Louis, Erik St ; Bukartyk, Jan ; Sompalli, Sreeja

Abstract:

Background:

Obstructive sleep apnea (OSA) is a risk factor for hypertension and some evidence suggests this risk may not be mitigated with positive airway pressure. Low-intensity statin therapy can modestly reduce blood pressure (BP). In this exploratory analysis, we examined if six months of high-intensity statin therapy could lower resting or ambulatory BP in patients with OSA.

Methods:

39 patients with OSA (13F, age = 49 ± 9yrs, body mass index = 32.9 ± 4.2kg/m2, apnea-hypopnea index = 22.2 ± 12.4 events/hour) were randomized to high-intensity atorvastatin or placebo. BP was assessed using seated, “office” measurements and in 20-minute intervals over 24 consecutive hours at three timepoints (baseline, three- and six-months post-randomization). Participants maintained a diary denoting sleep and wake times for analysis. Changes (Δ) in BP from baseline were assessed and adjusted for adherence to participants’ intervention (atorvastatin or placebo) as well as to their treatment for OSA (yes or no).

Results:

There were no between-group differences in baseline BP variables (P = .09-.96). At three months, the changes in resting (P = .74-.87), 24 hour mean (P = .54-.96), daytime (P = .70-.96), nor nighttime (P = .74-.96) BP did not differ between groups. Similarly, the changes in resting (P = .23-.92), 24 hour mean (P = .51-.82), daytime (P = .17-.78), and nighttime (P = .51-1.00) BP did not differ between groups following six months of their respective intervention.

Conclusions:

Our data suggest that high-intensity atorvastatin does not lower resting or ambulatory BP in patients with OSA relative to a placebo. Thus, it does not appear that atorvastatin is a viable adjunct intervention for BP reduction in patients with OSA.

Registration:

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03308578.

01 Mar 2026·CPT-Pharmacometrics & Systems Pharmacology

Retrieval Augmented Generation ( RAG ) for Evaluating Regulatory Compliance of Drug Information and Clinical Trial Protocols

Article

Author: Waikar, Shreyas ; Ramanathan, Murali ; Bhat, Amruta Gajanan

ABSTRACT:

The purpose was to evaluate retrieval‐augmented generative (RAG) artificial intelligence (AI) methods for assessing the regulatory compliance of drug information and adherence to best practices in clinical trial protocols. Integrated systems containing RAG and large language model (LLM) components were employed to evaluate drug information and clinical trial protocols. The drug information for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam was evaluated for compliance with Food and Drug Administration (FDA) clinical pharmacology guidance for indications, use in specific populations, and warnings and precautions. The reasons for the withdrawal of rofecoxib, valdecoxib, and troglitazone were elicited. The clinical trial protocol evaluation system was used to assess a Phase‐2a clinical trial protocol of Rifafour in tuberculosis with the FDA E9 and E9 (R1) guidance documents. The RAG system correctly identified the indications, use in specific populations, and warnings and precautions for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam. The drug information was evaluated against the requirements in the guidance documents, confirming compliance when present and providing explanations for deficiencies. The causes underlying the withdrawal of rofecoxib, valdecoxib, and troglitazone were explained. The clinical protocol summary included study design, population definitions, treatments, dose levels, and route of administration. The summary of the statistical analysis plan included primary/secondary endpoints, statistical tests, pharmacokinetic parameters, and handling of missing data and outliers. The findings aligned with manual protocol reviews. RAG‐based AI methods can improve the usefulness of LLMs in document‐restricted settings and are a promising approach for evaluating the compliance of clinical pharmacology documents.

03 Feb 2026·Journal of the American Heart Association

Recurrent Symptomatic Hemorrhage in Cerebral Cavernous Malformations After Discontinuation of Atorvastatin or Placebo

Article

Author: Alcazar‐Felix, Roberto J. ; Sorrentino, Matthew ; Sader, Georgio ; Stadnik, Agnieszka ; Shenkar, Robert ; Flemming, Kelly D. ; Thompson, Richard E. ; Ali, Bader ; Girard, Romuald ; Polster, Sean P. ; Liao, James K. ; Awad, Issam A. ; Lee, Justine ; Hanley, Daniel F.

Background:

A recent randomized prospective controlled trial demonstrated that atorvastatin for up to 2 years was safe but did not significantly alter rebleeding in cerebral cavernous malformations. However, any consequences of discontinuing atorvastatin remain unknown. We hypothesized that symptomatic hemorrhage (SH) recurs more frequently in cerebral cavernous malformations after discontinuation of atorvastatin than placebo.

Methods:

We conducted a 12‐month posttreatment follow‐up of patients enrolled in the Atorvastatin Therapy in Cavernous Angiomas with Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) trial (41 randomized to atorvastatin, 39 to placebo) to identify potential recurrent SH after trial drug discontinuation. Every SH was adjudicated by review of imaging and corresponding symptoms. Patients were excluded from follow‐up for <90% compliance with study drug, for its discontinuation <3 months after trial enrollment, for statin reinitiation <3 months after discontinuation, or for lack of follow‐up. Cases were censored during follow‐up upon cerebral cavernous malformation resection/radiation or later statin reinitiation.

Results:

Follow‐up included 33 patients who had been randomized to placebo and 32 who had taken atorvastatin. Four SH events occurred at 3, 49, 84, and 225 days after atorvastatin discontinuation, and 1 SH at 395 days after discontinuing placebo. There was significantly lower symptomatic hemorrhage‐free survival in the atorvastatin‐discontinuation group (log‐rank χ 2 =4.136, P =0.042). The hazard ratio was 0.162 (95% CI, 0.027–0.977) for placebo versus atorvastatin discontinuation.

Conclusions:

Discontinuation of atorvastatin was associated with a higher risk of recurrent SH compared with placebo discontinuation. Additional studies are warranted to confirm this hypothesis‐generating observation, examine potential mechanisms, and how best to mitigate this risk.

REGISTRATION:

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02603328.

172

News (Medical) associated with Atorvastatin Calcium

01 May 2026

·www.fiercepharma.com

Cardio drug developer Esperion to go private in potential $1.1B buyout by ArchiMed

Esperion’s commercial portfolio became a bigger draw for ArchiMed after the Michigan-headquartered company announced in early March that it would acquire Corstasis and its edema drug Enbumyst. Shortly after laying out $75 million upfront for Corstasis Therapeutics and its congestive heart failure edema drug Enbumyst, Esperion Therapeutics is itself being acquired and taken private by healthcare investment firm Archimed. On Friday, the companies announced that Archimed will pay $3.16 per share for Esperion at closing on May 1, alongside a potential CVR sweetener of contingent milestone payments tied to the future sales performance of Esperion’s Nexletol, Nexlizet and Enbumyst that could reach up to $100 million. All told, the deal could be worth up to $1.1 billion, assuming those commercial milestones are met, the companies said in a release. The upfront consideration from Archimed marks a 58% premium on Esperion’s closing share price on April 30. “This transaction marks an exciting new chapter for Esperion, our employees, and the patients and healthcare professionals we serve,” Sheldon Koenig, Esperion’s CEO, said in a statement. He added that the acquisition “provides our shareholders with attractive and immediate upfront value at a compelling premium, while preserving the opportunity to participate in additional upside through contingent milestone payments tied to the future growth of our core cardiometabolic products.” Archimed and Esperion broke down the sales thresholds the latter’s drugs must meet in order to unlock the deal’s full value. Contingent payments of $40 million are tied to 2027 sales of the cholesterol-lowering drugs Nexletol and Nexlizet, surpassing $350 million, per the companies’ release. If those sales breach $300 million but don’t meet the $350 million mark, Archimed is pledging a lesser payout “determined by linear interpretation” of the meds’ performance. Meanwhile, Enbumyst, the nasal spray for edema associated with congestive heart failure that Esperion picked up through its Corstasis buyout, could net Esperion shareholders another $60 million from the CVR framework if its revenues exceed $160 million in any single calendar year through 2030. Archimed’s purchase is expected to close in the third quarter. Once the deal has gone through, Esperion will become privately held and delist its stock from the Nasdaq. Esperion is no stranger to being an acquisition target, having been acquired by Pfizer after its role in developing the cholesterol drug Lipitor in 2004. Four years later, however, amid a restructuring, Pfizer turned the company and its assets back over to its original founder. Esperion then went public in 2013. Esperion’s commercial portfolio no doubt became a bigger draw for Archimed after the Michigan-headquartered company announced in early March that it would acquire Corstasis and its Enbumyst. Approved in September, the nasal spray is a loop diuretic that relieves the edema associated with congestive heart failure, chronic kidney disease and liver disease. At the time, Esperion noted that it believes Enbumyst represents a potential $4.6 billion opportunity in the U.S. alone.

AcquisitionDrug Approval

27 Apr 2026

·www.businesswire.com

SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s SAPHNELO® (anifrolumab-fnia) has been approved in the US for self-administration as a once-weekly autoinjector, the SAPHNELO Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of SAPHNELO led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy.1,2 Full results from the TULIP-SC trial were published in Arthritis & Rheumatology in January 2026. The safety profile observed was consistent with the known clinical profile of SAPHNELO administered as an intravenous (IV) infusion.3-5 Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute and principal investigator of the TULIP-SC trial, said: “The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients. With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.” Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America, said: “The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Since its launch, SAPHNELO IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the SAPHNELO Pen represents a significant step forward in expanding SAPHNELO’s clinical benefits to more people living with systemic lupus erythematosus.” SLE is among the leading causes of death in young women in the US and is more common among Asian, Black or Hispanic populations.6,7 While oral corticosteroids are often used to provide relief from SLE symptoms, they are associated with adverse events and do not target the underlying drivers of the disease.8-10 Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimizing the use of oral corticosteroids.11,12 Subcutaneous administration of SAPHNELO is approved in the EU and Japan and under regulatory review in several other countries around the world. SAPHNELO IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the US and EU. To date, more than 40,000 patients globally have been treated with SAPHNELO.13 SAPHNELO IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission.14,15 Financial considerations AstraZeneca acquired global rights to SAPHNELO through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the US. SAPHNELO® (anifrolumab-fnia) IMPORTANT SAFETY INFORMATION CONTRAINDICATION Known history of anaphylaxis with SAPHNELO. WARNINGS AND PRECAUTIONS Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Use caution in patients with severe or chronic infections. Avoid initiating treatment during an active infection and consider interrupting therapy in patients who develop a new infection during treatment Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis and infusion-related reactions, if they occur. Immediately interrupt administration and initiate appropriate therapy if a serious infusion-related or hypersensitivity reaction (eg, anaphylaxis) occurs Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO on the potential development of malignancies is not known Immunization: Avoid the use of live or live-attenuated vaccines in patients treated with SAPHNELO Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster and cough. In the controlled clinical trials, the incidence of infusion-related reactions was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness. USE IN SPECIFIC POPULATIONS Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1-877-693-9268. There are insufficient data on the use of SAPHNELO in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO. Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established. INDICATION SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations. Please see full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. Notes Systemic lupus erythematosus SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.16 It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints and fevers.11,12,16,17 Over 3.4 million people globally are affected by SLE.18 Living with SLE can be painful, debilitating, have a profound impact on patients’ mental and financial wellbeing.17,19-23 An estimated 50% of people with SLE have irreversible organ damage within five years of diagnosis due to long-term corticosteroid use and disease activity.9,23 Even a small reduction in daily steroid use (for example 1mg/day) can lower the risk of organ damage.24 TULIP-SC TULIP-SC was a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderate to severe SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants).25 The primary endpoint was the reduction of disease activity measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.25 The BICLA requires improvement in all organs with disease activity at baseline with no new flares.25 In the TULIP-SC trial, SAPHNELO demonstrated clinically meaningful effects across a range of outcome measures: reduction in SLE disease activity while tapering to low dose of OCS (≤7.5 mg/day), more patients achieving a BICLA response sooner, and numerically delayed time to first flare.25,26 In pre-specified secondary and exploratory endpoints, 29.0% of patients taking SAPHNELO achieved DORIS remission and 40.1% attained low-level disease activity, as measured by the Low-Level Disease Activity Score (LLDAS).25,26 Participants (367) were randomized 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered via a pre-filled, single-use syringe.25 A planned interim analysis was conducted when the first 220 participants reached week 52 or withdrew from the study.25 The trial also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period.25 The SAPHNELO Pen SAPHNELO will be available for subcutaneous self-administration via a once-weekly 120mg autoinjector (the SAPHNELO Pen) or a pre-filled syringe. Subcutaneous administration of SAPHNELO was approved in the EU and Japan. Since 2021, SAPHNELO has been available in an IV infusion administered by healthcare professionals in a hospital or clinic setting. The SAPHNELO Pen offers patients the choice to self-administer treatment outside of the clinic or with support from an HCP or caregiver via a simple process. SAPHNELO SAPHNELO (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN.5,27 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE.28-33 SAPHNELO IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) measured with the DORIS criteria for remission.14,15 DORIS is measured as clinical SLEDAI-2K, or “Systemic Lupus Erythematosus Disease Activity Index 2000” score of 0, physician global assessment <0.5, prednisolone/ equivalent dose of OCS dose of ≤5 mg per day and stable maintenance doses of immunosuppressants, including biologics.34 SAPHNELO continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.35-38 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. The contents of AstraZeneca’s website do not form part of this document and no one should rely on such websites or the contents thereof in reading this document. References AstraZeneca. Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis. Available at: Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis . [Last accessed: April 2026]. Furie R, et al. What does it mean to be a British Isles Lupus Assessment Group–based composite lupus assessment responder? Post hoc analysis of two Phase III trials. Arthritis Rheumatol . 2021;73(11):2059-2068. Morand E, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med . 2020;382(3):211-221. Furie R, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol . 2019;1(4):e208-e219. Furie R, et al. Anifrolumab, an anti–interferon‐α receptor monoclonal antibody, in moderate‐to‐severe systemic lupus erythematosus. Arthritis Rheumatol . 2017;69(2):376-386. The Rheumatologist. SLE Is a leading cause of death among women. Available at: https://www.the-rheumatologist.org/article/sle-is-a-leading-cause-of-death-among-women . [Last accessed: April 2026]. Izmirly PM, et al. Prevalence of Systemic Lupus Erythematosus in the United States: Estimates From a Meta-Analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol . 2021;73(6):991-996. Apostolopoulos D and Morand EF. It hasn’t gone away: the problem of glucocorticoid use in lupus remains. Rheumatology (Oxford) . 2017;56(Suppl 1):i114-i122. Ji L, et al. Low-dose glucocorticoids should be withdrawn or continued in systemic lupus erythematosus? A systematic review and meta-analysis on risk of flare and damage accrual. Rheumatology . 2021;60(12):5517-5526. Lateef A and Petri M. Unmet medical needs in systemic lupus erythematosus. Arthritis Res Ther . 2012;14(Suppl 4):S4. American College of Rheumatology. 2025 American College of Rheumatology (ACR) guideline for the treatment of systemic lupus erythematosus (SLE). Available at: lupus-guideline-sle-2025.pdf . [Last accessed: April 2026]. Fanouriakis A, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis . 2024;83(1):15-29. AstraZeneca data on file. 2025. REF-290598. Morand EF, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis . 2025; 84(5): 777-778. Mosca M, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Ann Rheum Dis . 2025. 84(1):168-169. Bruce IN, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort. Ann Rheum Dis . 2015;74(9):1706-1713. Kaul A, et al. Systemic lupus erythematosus. Nat Rev Dis Primers . 2016;2:16039. Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis . 2023;82(3):351-356. Elefante E, et al. Impact of disease activity patterns on health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE). Lupus Sci Med . 2024;11:e001202. Primavera D, et al. Quality of Life in Systemic Lupus Erythematosus and Other Chronic Diseases: Highlighting the Amplified Impact of Depressive Episodes. Healthcare . 2024;12:233. 25. Liu X, et al. Mental health conditions in patients with systemic lupus erythematosus: a systematic review and meta-analysis. Rheumatology (Oxford). 2024;63:3234-3242. Leung J, et al. “…Not Having the Real Support That We Need”: Patients’ Experiences With Ambiguity of Systemic Lupus Erythematosus and Erosion of Social Support. ACR Open Rheumatol . 2019;1:135-144. Murimi-Worstell IB, et al.: Healthcare utilization and costs of systemic lupus erythematosus by disease sever- ity in the United States. J Rheumatol 2021; 48: 385-93. Katsumata Y, et al. Risk of flare and damage accrual after tapering glucocorticoids in modified serologically active clinically quiescent patients with systemic lupus erythematosus: a multinational observational cohort study. Ann Rheum Dis . 2024;83(8):998-1005. Clinicaltrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). Available at: https://clinicaltrials.gov/study/NCT04877691 . [Last accessed: April 2026]. Manzi S, et al. Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: the Randomized, Phase 3, TULIP-SC Study. Arthritis Rheumatol. 2025. doi: 10.1002/art.70041. Riggs JM, et al. Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. Lupus Sci Med . 2018;5(1):e000261. Lauwerys BR, et al. Type I interferon blockade in systemic lupus erythematosus: where do we stand? Rheumatology . 2014;53(8):1369-1376. Sarkar MK, et al. Photosensitivity and type I IFN responses in cutaneous lupus are driven by epidermal-derived interferon kappa. Ann Rheum Dis . 2018;77(11):1653-1664. Jefferies CA. Regulating IRFs in IFN driven disease. Front Immunol . 2019;10:325. Mai L, et al. The baseline interferon signature predicts disease severity over the subsequent years in systemic lupus erythematosus. Arthritis Res Ther . 2021;23(1):29. López de Padilla CM, et al. The type I interferons: basic concepts and clinical relevance in immune-mediated inflammatory diseases. Gene . 2016;576(101):14-21. Rönnblom L, et al. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med . 2019;6(1):e000270. Vollenhoven R, et al. 2021 DORIS definition of remission in SLE: final recommendations from an international task force. Lupus Science & Medicine . 2021; 8: e000538. doi:10.1136/ lupus-2021-000538. Clinicaltrials.gov. A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/ or Subacute Cutaneous Lupus Erythematosus (LAVENDER). Available at: https://clinicaltrials.gov/study/NCT06015737 . [Last accessed: April 2026]. Clinicaltrials.gov. A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) (JASMINE). Available at: https://clinicaltrials.gov/study/NCT06455449 . [Last accessed: April 2026]. Clinicaltrials.gov. Determine Effectiveness of Anifrolumab in Systemic Sclerosis (DAISY). Available at: https://clinicaltrials.gov/study/NCT05925803 . [Last accessed: April 2026]. ClinicalTrials.gov. Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis (IRIS). Available at: https://www.clinicaltrials.gov/ct2/show/NCT05138133 . [Last accessed: April 2026].

Phase 3Clinical ResultDrug ApprovalAcquisitionLicense out/in

27 Apr 2026

·www.astrazeneca.com

Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy.1,2 Full results from the TULIP-SC trial were published in Arthritis & Rheumatologyin January 2026. The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.3-5 Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute and principal investigator of the TULIP-SC trial, said: “The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients. With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.” Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America, said: “The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo’s clinical benefits to more people living with systemic lupus erythematosus.” SLE is amongst the leading causes of death in young women in the US and is more common amongst Asian, Black or Hispanic populations.6,7 While oral corticosteroids are often used to provide relief from SLE symptoms,they are associated with adverse events and do not target the underlying drivers of the disease.8-10 Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimising the use of oral corticosteroids.11,12 Subcutaneous administration of Saphnelo is approved in the EU and Japan and under regulatory review in several other countries around the world. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the US and EU. To date, more than 40,000 patients globally have been treated with Saphnelo.13 Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission.14,15 Financial considerations AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the US. Notes Systemic lupus erythematosus SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.16 It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints and fevers.11,12,16,17 Over 3.4 million people globally are affected by SLE.18 Living with SLE can be painful, debilitating, have a profound impact on patients’ mental and financial wellbeing.17,19-23 An estimated 50% of people with SLE have irreversible organ damage within five years of diagnosis due to long-term corticosteroid use and disease activity.9,23 Even a small reduction in daily steroid use (for example 1mg/day) can lower the risk of organ damage.24 TULIP-SC TULIP-SC was a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderate to severe SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants).25 The primary endpoint was the reduction of disease activity measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.25 The BICLA requires improvement in all organs with disease activity at baseline with no new flares.25 In the TULIP-SC trial, Saphnelo demonstrated clinically meaningful effects across a range of outcome measures: reduction in SLE disease activity while tapering to low dose of OCS (≤7.5 mg/day), more patients achieving a BICLA response sooner, and numerically delayed time to first flare.25,26 In pre-specified secondary and exploratory endpoints, 29.0% of patients taking Saphnelo achieved DORIS remission and 40.1% attained low-level disease activity, as measured by the Low-Level Disease Activity Score (LLDAS).25,26 Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered via a pre-filled, single-use syringe.25 A planned interim analysis was conducted when the first 220 participants reached week 52 or withdrew from the study.25 The trial also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period.25 The Saphnelo Pen Saphnelo will be available for subcutaneous self-administration via a once-weekly 120mg autoinjector (the Saphnelo Pen) or a pre-filled syringe. Subcutaneous administration of Saphnelo was approved in the EU and Japan. Since 2021, Saphnelo has been available in an IV infusion administered by healthcare professionals in a hospital or clinic setting.The Saphnelo Pen offers patients the choice to self-administer treatment outside of the clinic or with support from an HCP or caregiver via a simple process. Saphnelo Saphnelo (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN.5,27 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE.28-33 Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) measured with the DORIS criteria for remission.14,15 DORIS is measured as clinical SLEDAI-2K, or “Systemic Lupus Erythematosus Disease Activity Index 2000” score of 0, physician global assessment <0.5, prednisolone/ equivalent dose of OCS dose of ≤5 mg per day and stable maintenance doses of immunosuppressants, including biologics.34 Saphnelo continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.35-38 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. AstraZeneca. Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis. Available at: Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis. [Last accessed: April 2026]. 2. Furie R, et al. What does it mean to be a British Isles Lupus Assessment Group–based composite lupus assessment responder? Post hoc analysis of two Phase III trials. Arthritis Rheumatol. 2021;73(11):2059-2068. 3. Morand E, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie R, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Furie R, et al. Anifrolumab, an anti–interferon‐α receptor monoclonal antibody, in moderate‐to‐severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. 6. The Rheumatologist. SLE Is a leading cause of death among women. Available at: https://www.the-rheumatologist.org/article/sle-is-a-leading-cause-of-death-among-women. [Last accessed: April 2026]. 7. Izmirly PM, et al. Prevalence of Systemic Lupus Erythematosus in the United States: Estimates From a Meta-Analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol. 2021;73(6):991-996. 8. Apostolopoulos D and Morand EF. It hasn’t gone away: the problem of glucocorticoid use in lupus remains. Rheumatology (Oxford). 2017;56(Suppl 1):i114-i122. 9. Ji L, et al. Low-dose glucocorticoids should be withdrawn or continued in systemic lupus erythematosus? A systematic review and meta-analysis on risk of flare and damage accrual. Rheumatology. 2021;60(12):5517-5526. 10. Lateef A and Petri M. Unmet medical needs in systemic lupus erythematosus. Arthritis Res Ther. 2012;14(Suppl 4):S4. 11. American College of Rheumatology. 2025 American College of Rheumatology (ACR) guideline for the treatment of systemic lupus erythematosus (SLE). Available at: lupus-guideline-sle-2025.pdf. [Last accessed: April 2026]. 12. Fanouriakis A, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29. 13. AstraZeneca data on file. 2025. REF-290598. 14. Morand EF, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. 2025; 84(5): 777-778. 15. Mosca M, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Ann Rheum Dis. 2025. 84(1):168-169. 16. Bruce IN, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort. Ann Rheum Dis. 2015;74(9):1706-1713. 17. Kaul A, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016;2:16039. 18. Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82(3):351-356. 19. Elefante E, et al. Impact of disease activity patterns on health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE). Lupus Sci Med. 2024;11:e001202. 20. Primavera D, et al. Quality of Life in Systemic Lupus Erythematosus and Other Chronic Diseases: Highlighting the Amplified Impact of Depressive Episodes. Healthcare. 2024;12:233. 25. 21. Liu X, et al. Mental health conditions in patients with systemic lupus erythematosus: a systematic review and meta-analysis. Rheumatology (Oxford). 2024;63:3234-3242. 22. Leung J, et al. “…Not Having the Real Support That We Need”: Patients’ Experiences With Ambiguity of Systemic Lupus Erythematosus and Erosion of Social Support. ACR Open Rheumatol. 2019;1:135-144. 23. Murimi-Worstell IB, et al.: Healthcare utilization and costs of systemic lupus erythematosus by disease sever- ity in the United States. J Rheumatol 2021; 48: 385-93. 24. Katsumata Y, et al. Risk of flare and damage accrual after tapering glucocorticoids in modified serologically active clinically quiescent patients with systemic lupus erythematosus: a multinational observational cohort study. Ann Rheum Dis. 2024;83(8):998-1005. 25. Clinicaltrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). Available at: https://clinicaltrials.gov/study/NCT04877691. [Last accessed: April 2026]. 26. Manzi S, et al. Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: the Randomized, Phase 3, TULIP-SC Study. Arthritis Rheumatol. 2025. doi: 10.1002/art.70041. 27. Riggs JM, et al. Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. Lupus Sci Med. 2018;5(1):e000261. 28. Lauwerys BR, et al. Type I interferon blockade in systemic lupus erythematosus: where do we stand? Rheumatology. 2014;53(8):1369-1376. 29. Sarkar MK, et al. Photosensitivity and type I IFN responses in cutaneous lupus are driven by epidermal-derived interferon kappa. Ann Rheum Dis. 2018;77(11):1653-1664. 30. Jefferies CA. Regulating IRFs in IFN driven disease. Front Immunol. 2019;10:325. 31. Mai L, et al. The baseline interferon signature predicts disease severity over the subsequent years in systemic lupus erythematosus. Arthritis Res Ther. 2021;23(1):29. 32. López de Padilla CM, et al. The type I interferons: basic concepts and clinical relevance in immune-mediated inflammatory diseases. Gene. 2016;576(101):14-21. 33. Rönnblom L, et al. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019;6(1):e000270. 34. Vollenhoven R, et al. 2021 DORIS definition of remission in SLE: final recommendations from an international task force. Lupus Science & Medicine. 2021; 8: e000538. doi:10.1136/ lupus-2021-000538. 35. Clinicaltrials.gov. A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/ or Subacute Cutaneous Lupus Erythematosus (LAVENDER). Available at: https://clinicaltrials.gov/study/NCT06015737. [Last accessed: April 2026]. 36. Clinicaltrials.gov. A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) (JASMINE). Available at: https://clinicaltrials.gov/study/NCT06455449. [Last accessed: April 2026]. 37. Clinicaltrials.gov. Determine Effectiveness of Anifrolumab in Systemic Sclerosis (DAISY). Available at: https://clinicaltrials.gov/study/NCT05925803. [Last accessed: April 2026]. 38. ClinicalTrials.gov. Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis (IRIS). Available at: https://www.clinicaltrials.gov/ct2/show/NCT05138133. [Last accessed: April 2026]. Matthew Bowden Company Secretary AstraZeneca PLC Corporate and financial

Phase 3Clinical ResultDrug ApprovalAcquisitionLicense out/in

100 Deals associated with Atorvastatin Calcium

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KEGG	Wiki	ATC	Drug Bank
D02258	Atorvastatin Calcium	C10AA05	DBSALT000011

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	United States	Upjohn Manufacturing Ireland Unlimited Co.	02 Mar 2007
Angina Pectoris	United States	Upjohn Manufacturing Ireland Unlimited Co.	21 Sep 2005
Myocardial Infarction	United States	Upjohn Manufacturing Ireland Unlimited Co.	21 Sep 2005
Stroke	United States	Upjohn Manufacturing Ireland Unlimited Co.	21 Sep 2005
Heterozygous familial hypercholesterolemia	United States	Upjohn Manufacturing Ireland Unlimited Co.	18 Oct 2002
Hypercholesterolemia, Familial	Japan	Pfizer Inc.	10 Mar 2000
Hypercholesterolemia, Familial	Japan	Astellas Pharma, Inc.	10 Mar 2000
Hypercholesterolemia, Familial	Japan	Viatris Pharmaceutical GK	10 Mar 2000
Coronary Disease	China	Beijing Jialin Pharmaceutical Co., Ltd.	01 Jan 1999
Hypercholesterolemia	Australia	Aspen Pharmacare Australia Pty Ltd.	25 Sep 1997
Hypertension	Australia	Aspen Pharmacare Australia Pty Ltd.	25 Sep 1997
Homozygous familial hypercholesterolemia	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996
Hyperlipidemia Type IIa	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996
Hyperlipoproteinemia Type IIb	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996
Hyperlipoproteinemia Type III	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996
Hyperlipoproteinemia Type IV	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996
Primary hypercholesterolemia	United States	Upjohn Manufacturing Ireland Unlimited Co.	17 Dec 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 3	Thailand	Pfizer Inc.	01 Jan 2014
Immune Reconstitution Inflammatory Syndrome	Phase 3	Thailand	Pfizer Inc.	01 Jan 2014
Tuberculosis	Phase 3	Thailand	Pfizer Inc.	01 Jan 2014
Diabetes Mellitus, Type 2	Phase 3	Malaysia	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 2	Phase 3	Mexico	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 2	Phase 3	Philippines	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 2	Phase 3	Russia	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 2	Phase 3	South Korea	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 2	Phase 3	Thailand	GSK Plc	01 Dec 2011
Diabetes Mellitus, Type 1	Phase 3	United States	Pfizer Inc.	01 Oct 2010

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02850081 (STANCE, CTgov)	Phase 3	Stroke \| Carotid Stenosis	31	Simvastatin+Atorvastatin+Rosuvastatin+amlodipine (Observational - Maximal Dose - ARM 1)	vjtktiwgzl = kgqqqhccsk ytgmilfohe (zqebpaxpgc, qeamtyiycw - bkwmuozkgk)	-	07 May 2026
				Statin (Less Than Maximal Dose - ARM 2)	vjtktiwgzl = xmqjshxplq ytgmilfohe (zqebpaxpgc, qyjolbxagc - jpkjptmwof)
NCT04747847 (CTgov)	Early Phase 1	Coronary Occlusion \| Mucocutaneous Lymph Node Syndrome	5	Atorvastatin+anakinra	islsdyvwtn = yhgplbpbhy tkwdrcepdi (dvptfvgypw, yacwzsjrkw - ezszzested) View more	-	25 Feb 2026
NCT05761444 (Pubmed \| BMC Cardiovasc Disord)	Phase 4	Atherosclerosis	137	Ezetimibe 10mg/Atorvastatin 40mg combination therapy	ckxwxiorui(xzdsmwkgha) = werhkdrejq yrlhfeurzz (fdpthstvdu ) View more	Positive	11 Feb 2026
				Atorvastatin 40mg statin alone	ckxwxiorui(xzdsmwkgha) = zwqqvjtmko yrlhfeurzz (fdpthstvdu ) View more
NCT02603328 (AT CASH EPOC, Pubmed \| J Am Heart Assoc)	Phase 1/2	Central Nervous System Cavernous Hemangioma	65	Atorvastatin	kzcfheagjy(spcbodmuoo) = eebboqkqyl damolmfwgm (jfhcvjfgmf )	Positive	03 Feb 2026
				Placebo	kzcfheagjy(spcbodmuoo) = ydoosyuirs damolmfwgm (jfhcvjfgmf )
NCT02943590 (STOP-CA, Pubmed \| JAMA Cardiol)	Phase 2	Lymphoma	300	Atorvastatin 40 mg	oalsbcuglg(csullizzky) = udfsyeufly ionrzjdftj (hrxwkarnav ) View more	Positive	08 Nov 2025
				Placebo	oalsbcuglg(csullizzky) = wsrjmjcvez ionrzjdftj (hrxwkarnav ) View more
NCT05567068 (Pubmed \| Front Pharmacol)	Phase 2	Colitis, Ulcerative	54	5-ASA plus Atorvastatin	ftusejpcdv(zvnxmrymay): P-Value = 0.027 View more	Positive	29 Oct 2025
				5-ASA plus placebo
NCT01988571 (Preventing Anthracycline Cardiovascular Toxicity With Statins, Pubmed \| JAMA Netw Open)	Phase 3	Breast Cancer \| Lymphoma	238	Atorvastatin 40 mg	chuzfeqatq(oupflhwmhk) = mfbbfblrvo zsqhajqfde (qupjsugjpy, 2.69 - 6.79) View more	Positive	21 Oct 2025
				Placebo	chuzfeqatq(oupflhwmhk) = qjeejjulsq zsqhajqfde (qupjsugjpy, 1.71 - 5.54) View more
NCT02603328 (AT CASH EPOC, Pubmed \| Neurosurgery)	Phase 2	Cavernous Hemangioma	100	Atorvastatin	zoecpwbygo(djvalrnlfa) = cwztlpdmbo nttksvwhoz (gcngsymspy, 65.0)	Negative	21 Oct 2025
				Placebo	zoecpwbygo(djvalrnlfa) = zhpofhbppg nttksvwhoz (gcngsymspy, 94.0)
NCT03308578 (Pubmed \| Am J Hypertens)	Phase 2	Sleep Apnea, Obstructive	39	High-Intensity Atorvastatin	zbiamuabbk(wnjscwtqpl): P-Value = 0.51 View more	Negative	10 Oct 2025
				Placebo
NCT02603328 (AT CASH EPOC, CTgov)	Phase 1/2	Hemorrhage \| Central Nervous System Cavernous Hemangioma	80	Atorvastatin (Treatment)	acnsqbgano(pvaivvrcje) = odyxhvjxfi znxscyictn (ntvhjibxjw, 9.77) View more	-	22 Aug 2025
				Placebo (Placebo)	acnsqbgano(pvaivvrcje) = spoljymsnx znxscyictn (ntvhjibxjw, 10.08) View more

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