The purpose of this study is to determine the clinical response to daily Indinavir oral administration in association with a conventional chemotherapy based on cycles of systemic Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated) Kaposi's sarcoma

Start Date01 Jun 2008

Sponsor / Collaborator

Istituto Superiore di Sanità

100 Clinical Results associated with Indinavir Sulfate

100 Translational Medicine associated with Indinavir Sulfate

100 Patents (Medical) associated with Indinavir Sulfate

3,642

Literatures (Medical) associated with Indinavir Sulfate

01 Jul 2026·SLAS Technology

Thermodynamics of custom-designed labware and an automated cryostorage system for human reproductive cells and tissues

Article

Author: Collins, Michael G ; Swain, Jason E ; Sarmiento, Alberto ; Spies, Kaylena

Human reproductive cells and tissues (eggs and embryos) are cryopreserved using vitrification for long-term storage at cryogenic temperatures (<-150 °C). Current equipment and processes, including data handling, are primarily manual. The central concern with any cryogenic storage system is the maintenance of specimen-level temperatures and prevention of excursions that could damage or destroy the cells and tissues. Automation and digital specimen management have recently become available to repositories storing human cells and tissues (Investigational Device (IDV)). To characterize the IDV and its components during normal operation and extreme conditions, a series of experiments were undertaken. These experiments compared the IDV labware with current industry conventional devices (CD). Vitrified single-cell mouse embryos served to determine the highest safe temperature when left in ambient conditions for the IDV labware and CD. The results show that the IDV maintains temperatures well below critical during normal storage conditions and extreme automation conditions. When exposed to ambient temperatures, the CD labware warmed significantly (P < 0.001) faster to reach -100 °C (mean ± SD;165.0 ± 4.4 s) than the IDV components (693.5 ± 33.2 s), even with a lower starting temperature. The highest safe temperature for the model embryos was determined to be -80 °C with 100% of the IDV (n= 11) and CD (n= 12) embryos developing to the expanded blastocyst stage on day 5. The mean (±SD) time for the IDV components to reach safe temperature was 1002.25 ± 82.54 s, which was significantly greater than CD (251.63 ± 12.79 s; P ≤ 0.001). The IDV can maintain a safe temperature for human reproductive cells and tissues during normal usage. In the event of mishap and exposure to ambient temperatures, components of the IDV provide a safer specimen environment than CD by extending the time cells and tissues are kept at safe temperatures before returning to a cryogenic environment. Here, we demonstrate that transient exposure of mammalian embryos, in both the IDV and CD, to temperatures above the glass transition (T_g) did not inhibit development to the expanded blastocyst stage. Further studies to determine the impact of time, and not just transient exposure to temperatures above T_g on mammalian cells and tissues for both the IDV and CD are warranted.

01 May 2026·JOURNAL OF VIROLOGICAL METHODS

Development and application of a real-time RT-PCR assay for the specific detection of influenza D virus

Article

Author: Yuan, Wanzhe ; Wang, Jianchang ; Wang, Jinfeng ; Li, Ruiwen ; Ji, Xincheng ; Li, Ning ; Yang, Yue ; Liu, Libing ; Sun, Xiaoxia ; Yu, Jieshi

Since the influenza D virus (IDV) was first isolated from a swine exhibiting respiratory disease symptoms in the United States in 2011, it has been detected in various animals across more than 20 countries worldwide, including cattle, pigs, goats, sheep, and camels. IDV has emerged as a significant pathogen associated with bovine respiratory disease complex (BRDC). In this study, specific primers and a TaqMan probe were designed based on the conserved region in the PB1 gene to develop a highly specific and efficient real-time RT-PCR assay (RT-qPCR) for IDV. The RT-qPCR assay demonstrated excellent specificity for IDV, without cross-reactions with other common BRDC-associated pathogens. Using in vitro transcribed PB1 RNA as a template, the assay's limit of detection was established at 100 copies/reaction. Furthermore, the developed RT-qPCR assay was evaluated using 417 cattle nasal swab samples collected from 10 different regions in Hebei Province, China, between 2021 and 2022. The results showed that 33 samples (7.91 %) tested positive for IDV. The IDV HEF gene was amplified and sequenced in these 33 positive samples, yielding 10 HEF gene sequences that all belonged to the D/Yama2019 lineage, with nucleotide homology ranging from 98.7 % to 99.1 %. This study successfully developed an RT-qPCR assay for the specific and sensitive detection of IDV, which performed well on the cattle nasal samples. Additionally, it is the first to demonstrate the presence of IDV in cattle herds in Hebei Province, China.

13 Apr 2026·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

Insights into the interaction mechanism of first-generation HIV-1 protease inhibitors with wild-type and mutant (D30N and L76V) enzymes through in-silico based approach

Article

Author: S, Pandarinathan ; S, Jayanthi

The combined effort of medical, scientific and pharmaceutical research has transformed the HIV infection from an inevitably fatal disease into a manageable chronic ailment. Especially after the introduction of protease (PR) inhibitors the efficacy of the treatment regimen has been increased. However, the development of mutant PR enzymes is a major concern. The present study focuses on to understand the alterations in wild-type and mutants (D30N and L76V) PR structure by interaction of first-generation PR inhibitors amprenavir, indinavir, nelfinavir, ritonavir and saquinavir. This information is extracted using molecular docking and MD simulation. Further, post-MD analysis such as RMSD, RMSF, PCA, DCCM, intermolecular interactions and binding free energy values calculation has been done. In comparison to L76V, D30N mutation affected the stable binding of the most of the studied PR inhibitors. The positively charged NH2 and thiazole group of amprenavir and nelfinavir is repelled by NH2 of Asn30 in D30N mutant. This repulsion pushes the drugs towards flap domain and causes flap opening. The MD simulation reveals that amprenavir, nelfinavir and saquinavir drugs have good compatibility with L76V mutant PR enzyme whereas indinavir was affected by the same. L76V mutant does not form any direct interaction with the first line drugs; hence the drugs forming strong interactions with the active site, flap domain and substrate binding region residues are quite enough to manage the resistance provided by L76V mutant. The results provided the insight into the drug-resistant or drug-susceptibility mechanism of L76V and D30N mutation against first-generation PR inhibitors.

News (Medical) associated with Indinavir Sulfate

05 May 2026

·www.prnewswire.com

CUMBERLAND PHARMACEUTICALS REPORTS Q1 2026 FINANCIAL RESULTS & COMPANY UPDATE

Enters into Strategic Transaction, unlocking $100 million in value Sharpens focus on Orphan Drug candidates to address unmet medical needs NASHVILLE, Tenn., May 5, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders' equity. "We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company's evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders." RECENT COMPANY DEVELOPMENTS INCLUDE: Strategic Transaction Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland's portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders' approval and certain other customary closing conditions. This transaction is designed to unlock value and sharpen Cumberland's focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland's products will create more critical mass to support patient care and expand product distribution. Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future. Development Pipeline In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential. Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval. During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland's ifetroban candidate product for DMD patients. This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA. In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results. Cumberland's third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending. FINANCIAL RESULTS: Net Revenue: For first quarter of 2026, the Company's net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ® in China. Cumberland's branded portfolio revenue included $1.0 million for Kristalose®, $2.9 million for Sancuso®, $2.1 million for Vibativ®, $1.0 million for Caldolor® and $1.9 million for Talicia.® Operating Expenses: Total operating expenses for the quarter were $12.3 million. Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million. Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share. Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company's credit facility. Total shareholders' equity was $21.6 million on March 31, 2026. EARNINGS REPORT CALL: A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is . Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: . ABOUT CUMBERLAND PHARMACEUTICALS: Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote ® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor ® (ibuprofen) injection, for the treatment of pain and fever; Kristalose ® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso ® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol ® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia ® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at . About Acetadote ® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit . About Caldolor ® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Kristalose ® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit . About Sancuso ® ( granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit . About Vaprisol ® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit . About Vibativ ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit . About Talicia ® Talicia® is an FDA approved oral capsule for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection of the stomach and leading risk factor for gastric cancer. Talicia is listed as a first line option in the 2024 ACG Guideline for the treatment of H. pylori and features three key advantages: 1) high eradication rates - >90% in confirmed adherent patients, 2) the simplicity of an all-in-one capsule, and 3) low resistance to the two antibiotics - amoxicillin and rifabutin. For more information, please visit . FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "goal", "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include risks and uncertainties related to the strategic transaction, risks related to our ability to develop our pipeline of new product candidates, macroeconomic conditions, including changes in interest rates, inflation, tariffs, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization of intangible and right-of-use assets, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): Net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. (b) Represents the straight line reduction in carrying value of right-of-use assets. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo

Phase 2Drug ApprovalOrphan DrugAcquisitionFast Track

21 Apr 2026

·endpoints.news

FDA approves once-daily HIV pill from Merck

A new HIV treatment will soon come to market, and it will spearhead Merck’s attempt to be one of the leading drugmakers in a field many biotechs have deserted . The FDA greenlit Merck’s once-daily pill for adults with HIV-1 who are virologically suppressed, as a replacement for their current antiretroviral regimen. The US regulator approved Idvynso on Monday, according to an update to the FDA database on Tuesday. It came a week in advance of an April 28 PDUFA goalpost. Idvynso is a combination of doravirine and islatravir. Doravirine is an approved HIV medicine known as Pifeltro. Islatravir, meanwhile, is being studied in a suite of clinical trials testing it as a combination tool for once-daily and weekly treatment for HIV. The two-drug regimen passed two Phase 3 studies in this patient population last year. It’s since racked up wins in other settings as well . The commercialization go-ahead kickstarts what Merck hopes will become a $5 billion HIV treatment and prevention business with a variety of drugs in development, including a once-monthly PrEP tablet that entered Phase 3 last year. The New Jersey drugmaker has been in the HIV field since the early days of the decades-long epidemic, but HIV has made up a very small portion of the company’s revenues and R&D focus in recent years as oncology has been at the forefront with cancer immunotherapy Keytruda. Merck’s first work in the HIV space began in 1986, and it brought a protease inhibitor known as Crixivan to market in 1996. At the time, it was the fastest approval in FDA history. The other main branded drugmakers in the HIV field include Gilead and ViiV Healthcare, which is mainly owned by GSK. Shionogi also owns a portion of ViiV, and Pfizer recently announced it would exit its stake. HIV medicines and PrEP drugs comprised 71% of Gilead’s revenues last year. The California biopharma is also attempting to make next-generation daily options like Merck. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.

Phase 3Drug ApprovalImmunotherapy

30 Mar 2026

·www.prnewswire.com

Calliditas Therapeutics AB to Present Exploratory Biomarker and Post-Hoc NefIgArd Analyses at the World Congress of Nephrology

Calliditas will present new secondary, biomarker, and mechanistic analyses from the Phase 3 NefIgArd study at the 2026 World Congress of Nephrology. Data further support Nefecon's gut–targeted, disease–modifying mechanism of action in IgA nephropathy. Calliditas to present seven posters and sponsor a scientific symposium highlighting the evolving IgAN treatment paradigm. STOCKHOLM, March 30, 2026 /PRNewswire/ -- Calliditas Therapeutics AB, an Asahi Kasei company, announced today that new data from the Phase 3 NefIgArd study in patients with primary immunoglobulin A nephropathy (IgAN) will be presented at the 2026 World Congress of Nephrology (WCN), taking place from March 28 to 31 in Yokohama, Japan. Nefecon's approval status, labeled indication, and availability vary globally. It is approved in the United States where it is marketed as TARPEYO® (budesonide) delayed-release capsules. It is available in Europe where it is marketed as Kinpeygo® by STADA Arzneimittel AG and in select countries in Asia, including Mainland China, Hong Kong, Macau, Taiwan, Singapore, and South Korea by Everest Medicines. It is also the subject of clinical trials in Japan by Viatris Pharamaceticals Japan Inc. The presentations will highlight secondary analyses from the Phase 3 NefIgArd study evaluating Nefecon, its effects on serum biomarkers associated with gut-associated lymphoid tissue (GALT) activity and the immunological impact of orally administered budesonide on B- and T-cell subsets in murine Peyer's patches following in vivo stimulation. These findings reinforce observations from earlier exploratory biomarker analyses and demonstrate the immunomodulatory effects in the Peyer's patches that underlie Nefecon's mechanism of action in modulating the mucosal immune system in the gut. Collectively, these data support a disease-modifying role for Nefecon in reducing levels of pathogenic galactose-deficient IgA1 in patients with IgAN. In total, 7 abstracts, of which 3 are based on secondary clinical efficacy and safety analyses from the Phase 3 NefIgArd study and 2 on mechanistic/biomarker analyses, will be presented. In addition, the initial demographics of the real-world PERFORM registry will be presented. Calliditas will also sponsor a symposium for educational scientific exchange, highlighting the evolving treatment paradigm in IgA nephropathy. Symposium and Presentation details as follows: Company Sponsored Symposium: Title: "The Evolving IgAN Treatment Paradigm: Why Target the Gut?" Date and time: March 30, 12:50 pm to 13:50 pm JST Presenters: Dr. Yusuke Suzuki, Juntendo University, Tokyo, Japan Dr. Sayna Norouzi, Loma Linda University Medical Center, Loma Linda, California, USA Dr. Chee Kay Cheung, University of Leicester, Leicester, UK Poster Presentations: Abstract No. WCN26-AB-8040 Title: "Impact of treatment with Nefecon on serum biomarkers of gut-associated lymphoid tissue function in patients with immunoglobulin A nephropathy from the Phase 3 NefIgArd trial" Date and time: March 30, 17:00 pm – 18:00 pm JST Presenter: Nadia Nawaz, College of Life Sciences, University of Leicester, Leicester, United Kingdom Abstract No. WCN26-AB-8197 Title: "Budesonide Modulates B- and T-Cell Immunity in Peyer's Patches: Implications for IgA Nephropathy" Date and time: March 28, 17:30 pm – 18:30 pm JST Presenter: Roza Ghotbi, Calliditas Therapeutics AB, Stockholm, Sweden Encore Poster Presentations: Title: "Urine protein–creatinine ratio response at 12 months in patients with immunoglobulin A nephropathy receiving Nefecon vs placebo: Analysis of NefIgArd trial data" Date and time: March 28, 17:30 pm – 18:30 pm JST Presenter: Richard Lafayette, Stanford University, CA Title: "Duration of absolute proteinuria response with Nefecon in patients with primary immunoglobulin A nephropathy: Results from the 2-year NefIgArd trial" Date and time: March 30, 17:00 pm – 18:00 pm JST Presenter: Brad Rovin , The Ohio State University Wexner Medical Center Title: "Absolute proteinuria over time with Nefecon vs placebo in patients with immunoglobulin A nephropathy: Results from the Phase 3 NefIgArd trial" Date and time: March 30, 17:00 pm – 18:00 pm JST Presenter: Heather Reich, University of Toronto Title: "The creation and initial demographics of the PERFORM™ Patient Registry: A novel real-world registry of patients treated for IgA nephropathy in the United States" Date and time: March 29, 17:00 pm – 18:00 pm JST Presenter: Russell Jones, Calliditas Therapeutics AB, Stockholm, Sweden Title: "Safety and preliminary efficacy findings from a Phase 2a randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome" Date and time: March 28, 17:30 pm – 18:30 pm JST Presenter: Daniel Gale , University College London The World Congress of Nephrology (WCN) is the flagship scientific, educational, and networking event of the International Society of Nephrology (ISN). Each year, WCN brings together kidney care professionals from around the world to exchange knowledge, showcase groundbreaking research, and participate in regionally-relevant symposia, training programs, and courses. About TARPEYO ® /Kinpeygo® TARPEYO is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-IgA1), causing IgA nephropathy. About Primary Immunoglobulin A Nephropathy Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic immune-mediated disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 containing immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s. IMPORTANT SAFETY INFORMATION FOR US AUDIENCE INDICATION TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations. WARNINGS AND PRECAUTIONS Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Immunosuppression and Increased Risk of Infection: Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed. Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi's sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, measles). Corticosteroid therapy may decrease the immune response to some vaccines. Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects. ADVERSE REACTIONS In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). DRUG INTERACTIONS Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide. USE IN SPECIFIC POPULATIONS Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information About Calliditas Therapeutics Calliditas Therapeutics is a biopharma company with offices in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. About Asahi Kase i Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world's challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit . SOURCE Calliditas Therapeutics 21% more press release views with Request a Demo

Phase 3Drug ApprovalClinical ResultPhase 2

100 Deals associated with Indinavir Sulfate

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KEGG	Wiki	ATC	Drug Bank
D00897	Indinavir Sulfate	J05AE02	DB00224

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Merck Sharp & Dohme Corp.	13 Mar 1996

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00411996 (Pubmed \| AIDS Res Hum Retroviruses)	Phase 1/2	HIV Infections nonnucleoside reverse transcriptase inhibitors (NNRTIs)	18	Indinavir/Ritonavir 600/100 mg	ireshbsmqn(tcchzqophm) = qmcakgxpat jarhxafgzw (lxlhhaniyq ) View more	-	01 Oct 2012
NCT00001566 (CTgov)	Phase 2	Rhabdomyosarcoma \| Ewing Sarcoma	42	peripheral blood stem cell transplantation+indinavir sulfate	ydwviimevl = qnswuleggd fdelmfbybk (mdwehrbcig, dfqadspdfp - ciykgdriwy) View more	-	12 Jun 2012
IAS2007	Not Applicable	Second line	492	Boosted indinavir plus NRTIs	efcmimmydl(grubnpicje) = iroprdmhtm mffczairam (wefzfjcejd )	-	01 Jan 2007
IAS2006	Not Applicable	-	61	IDV/r 800/100mg bid + EFV 600mg qd	qkklnscbkg(hdlftyyrvy) = nckdfzbazz jnoghndatd (rzxkkfvsme, 60 - 277) View more	-	01 Jan 2006
IAS2006	Not Applicable	-	22	Indinavir/ritonavir + nelfinavir	whkmeyepmi(ejhwyoxdep) = 20% gfwjhtyang (etlsbsvccv ) View more	-	01 Jan 2006
Pubmed \| AIDS	Phase 1	HIV Infections	-	Indinavir/ritonavir 800/200 mg	xinlyyhbix(setwjrvdmo) = pjcprfxdsv rueuqmfvlt (pxjgckfnak )	-	01 Jul 2005
Pubmed \| AIDS	Phase 1	HIV Infections	-	Indinavir/ritonavir 400/400 mg	xinlyyhbix(setwjrvdmo) = vkjxniwnxs rueuqmfvlt (pxjgckfnak )	-	01 Jul 2005
AMADEUS 01 Study (IAS2005)	Not Applicable	-	69	ZDV/3TC	rdxznkyxwt(qritnnmgyx) = Failure was due to adverse events in 18 patients, mainly with IDV/RTV (8 patients) and d4T/ddI (4 patients). Virological failure was present only in 2 patients, with a new major mutation (M184V) in one. Most failures were due to adverse events, significantly more frequent in patients receiving IDV/RTV. yaywgvrpof (tpimvkgfrf )	-	01 Jan 2005
AMADEUS 01 Study (IAS2005)	Not Applicable	-	69	d4T/ddI		-	01 Jan 2005
Pubmed	Phase 1/2	HIV Seropositivity	-	Indinavir 400/400 mg	zfcqydneiy(rswrcajlzw) = phczajttlo bbotiswqcs (buwqheowes )	-	01 Nov 2004
NCT00000903 (AIDS Clinical Trials Group protocol 388, Pubmed \| Antimicrob Agents Chemother)	Phase 3	HIV Infections	-	Indinavir	xirqunitqj(gqfxamasuu) = xoudpbadss egdufiawbf (erocnjuavz ) View more	-	01 Mar 2004
	Phase 3	HIV Infections	-	Nelfinavir	xirqunitqj(gqfxamasuu) = oocpzfcjzj egdufiawbf (erocnjuavz ) View more	-	01 Mar 2004
HIV-NAT 009 (IAS2004)	Not Applicable	-	61	Indinavir/ritonavir 800/100mg bid + Efavirenz 600mg qd	eqamawcxdv(mirsikhbvo) = twkqcfdnuw nrzpbnwvlw (xczcszvzac, -32.5 to to 2) View more	-	01 Jan 2004

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