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Last update 20 Mar 2025

Losartan Potassium

Last update 20 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(2-butyl-4-chloro-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazol-5-yl)methanol, 2-n-butyl-4-chloro-5-hydroxymethyl-1-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]imidazole, Losartan

+ [21]

Target

AT1R

Action

antagonists

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Diabetes Mellitus, Type 2Diabetic NephropathiesHypertrophy, Left Ventricular+ [2]

Inactive Indication

Diabetes Mellitus, Type 1Essential HypertensionHeart Failure+ [4]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Merck & Co., Inc.

Organon & Co.Scienture Holdings, Inc.

+ [2]

Inactive Organization

Merck Sharp & Dohme Corp.Merck Frosst Canada Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (14 Apr 1995),

Hypertension

RegulationOrphan Drug (European Union)

Structure/Sequence

Molecular FormulaC22H23ClKN6O

InChIKeyFDKIDFYIEWFERB-UHFFFAOYSA-N

CAS Registry124750-99-8

View All Structures (2)

402

Clinical Trials associated with Losartan Potassium

ChiCTR2500095733

/ SuspendedPhase 2IIT

The efficacy, safety, and tolerability of mFOLFIRINOX with or without losartan in patients after radical surgery for pancreatic cancer: an open-label, multicenter, randomized controlled phase II clinical trial.

Start Date14 Jan 2025

Sponsor / Collaborator

The Affiliated Hospital of Qingdao University

IRCT20241102063569N1

/ RecruitingPhase 3IIT

The effect of losartan drops on the healing of scars caused by corneal ulcers

Start Date16 Nov 2024

Sponsor / Collaborator

Mashhad University of Medical Sciences

CTR20243872

/ CompletedNot Applicable

氯沙坦钾片在中国健康受试者中的单次给药、随机、开放、四周期、完全重复交叉、空腹状态下的生物等效性研究

[Translation] A single-dose, randomized, open-label, four-period, complete repeated crossover, fasting bioequivalence study of losartan potassium tablets in healthy Chinese subjects

主要目的：以Merck Sharp&Dohme Limited持证的氯沙坦钾片（规格：100 mg，商品名：科素亚®）为参比制剂，以珠海润都制药股份有限公司研发的氯沙坦钾片（规格：0.1 g）为受试制剂，通过单中心、单次给药、随机、开放、四周期、完全重复交叉设计的临床研究来评价两种制剂在空腹状态下的人体生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: Using Losartan Potassium Tablets (Specification: 100 mg, Trade Name: Cozaar®) certified by Merck Sharp & Dohme Limited as the reference preparation and Losartan Potassium Tablets (Specification: 0.1 g) developed by Zhuhai Rundu Pharmaceutical Co., Ltd. as the test preparation, a single-center, single-dose, randomized, open, four-period, completely repeated crossover design clinical study was conducted to evaluate the bioequivalence of the two preparations in the fasting state. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date27 Oct 2024

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Losartan Potassium

100 Translational Medicine associated with Losartan Potassium

100 Patents (Medical) associated with Losartan Potassium

14,843

Literatures (Medical) associated with Losartan Potassium

01 Nov 2025·Current Drug Metabolism

Exploring Drug-Drug Interactions between Losartan and Carbamazepine: A Pharmacokinetic and Pharmacodynamic Study

Article

Author: Sundargowda, Shruthi A ; Kadiri, Sunil Kumar

Background:Hypertension, which affects 1.28 billion people globally aged 30 to 79, is characterized by continuously high blood pressure (140/90 or more) and raises the risk of premature death. Losartan, an angiotensin receptor blocker (ARB), is suggested for patients under the age of 55 who cannot take ACE inhibitors as a first treatment option. Epilepsy, a chronic neurological illness marked by repeated seizures, affects more than 50 million individuals worldwide and is the third most common chronic brain disorder. Both hypertension and epilepsy are frequent chronic illnesses, with increased blood pressure greatly raising the risk of epilepsy due to its relationship with cerebrovascular disease, doubling the risk when compared to people with normal blood pressure.Objective:The effect on pharmacokinetics and pharmacodynamics of losartan on concomitant administration with carbamazepine was investigated.Materials and Methods:Wistar rats of either sex, with a minimum of six animals per group, were used in the investigation. The rats were treated with Losartan and Losartan-Carbamazepine for 30 days. Blood samples were taken via retro-orbital plexus at 0, 1, 2, 4, 6, and 12 hours after treatment concluded, and they were subjected to high-performance liquid chromatography for plasma analysis to calculate AUC, t1/2, and Clearance. A pharmacodynamic evaluation was done by inducing hypertension in rats using a 10% fructose solution and the effect of pretreated Losartan and Losartan-Carbamazepine on blood pressure was determined.Results:In the Losartan and Carbamazepine treated group, there was a reduction in the AUC and t1/2 and a reported increase in the clearance value compared to Losartan alone treated rats. In fructose-induced hypertension model to evaluate the effect of losartan and carbamazepine on BP showed an increase in mean arterial pressure, plasma glucose, and a reduction in triglycerides level was noted in comparison to Losartan alone treated rats indicating therapeutic failure of Losartan.Conclusion:Based on these studies, it is concluded that CBZ has reduced the effectiveness of losartan and therefore, co-administration of these drugs should be avoided.

01 Apr 2025·Journal of Molecular Structure

Design, synthesis, and computational docking techniques of novel 1,2,3‒triazole‒tetrazole hybrids as potential leads in the development of anticancer agents

Author: Allaka, Tejeswara Rao ; Vudari, Balaraju ; Vellaiyan, Venkatesan ; Nagarajaiah, Honnappa ; Chepuri, Kalyani ; Bhoomandla, Srinu

New flurbiprofen linked 1,2,3-triazole and tetrazole scaffolds have been designed and synthesized using a Cu(I)-catalyzed azide-alkyne cycloaddition (CuAAC).All the synthesized compounds were examined for the growth inhibition of HepG2, HuH7, MCF-7, and T-47D tumor cells and binding with focusing on the human cytochrome P 450 2C9 active site was investigated using mol. modeling.There was a strong correlation between the data from the docking studies and the biol. screening results.The cell lines that responded to the novel compound′s effects the best were HepG2 and MCF-7.Compound 5j was the most efficacious derivative among the four cancer cells (HepG2, HuH7, MCF-7, and T-47D) having IC₅₀ values of 1.89 ± 0.103, 2.86 ± 0.167, 1.66 ± 0.056, and 3.55 ± 0.045 μM, resp. and it had greater activity than doxorubicin.In addition, an in silico docking anal. was carried out to confirm the results of the experimentThe results highlight the potential of our triazole-bridged tetrazoles when combined with flurbiprofen (PDB: 1R9O) to enter the active site of human cytochrome P 450 2C9.The proposed binding mode of ligand 5 g was shown three hydrogen bonding via tetrazole with Glu427 (N24...OE1), triazole with Ala280 (N17...O) and fluoro group with Arg80 (F28...NH2) residues their internuclear distances are 2.89 Å, 2.71 Å, and 3.19 Å resp.Furthermore, the ADMET profile was assessed for each mol., and the findings of the in vitro and in silico investigations indicate that the triazoles incorporating tetrazole provide important new information for the creation of innovative anti-cancer treatments.

01 Apr 2025·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Editorial Commentary: Prevention and Treatment of Hip Adhesions Associated With Hip Arthroscopy Shows Positive Outcomes

Author: McCrum, Christopher L.

Adhesions are known to occur following arthroscopic as well as open surgery of multiple joints, including after hip arthroscopy, resulting in pain, stiffness, and dysfunction. Adhesions of the labrum to the overlying hip capsule can lead to eversion of the labrum and potentially compromise the suction seal, leading to microinstability and pain. Generally, patient-reported outcomes improve after surgical lysis of adhesions, with or without concurrent correction of labral, chondral, or bony pathology. Arthroscopic placement of autograft or allograft spacers may be effective when adhesions between the labrum and capsule prevent an adequate suction seal. Prevention using biologics, such as angiotensin II receptor blockers (e.g., losartan), may inhibit transforming growth factor β1, which has been associated with fibrogenesis, tissue fibrosis, and scarring. Side effects of losartan are rare but include hypotension, dizziness, angioedema, and acute kidney injury when coprescribed with nonsteroidal anti-inflammatory drugs, which are often used in heterotopic ossification prophylaxis in hip arthroscopy and are a significant concern. More data on losartan use are required prior to broader adoption.

News (Medical) associated with Losartan Potassium

18 Mar 2025

·www.globenewswire.com

SCIENTURE announces the U.S. FDA Approval of its NDA for SCN-102, to be launched as ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024.

TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- – SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL. ArbliTM is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. ArbliTM is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market. ArbliTM is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. ArbliTM provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. ArbliTM has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook. Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. ArbliTM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market. “The approval of ArbliTM exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products,” remarked Shankar Hariharan, CEO of Scienture, LLC. “We are pleased to bring to market, ArbliTM, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers and healthcare professionals (HCPs). We expect to commercially launch and make ArbliTM available to patients in the U.S. in Q3 2025,” said Narasimhan Mani, President of Scienture, LLC. “This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc. About ArbliTM ArbliTM is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature. INDICATION ArbliTM is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. IMPORTANT SAFETY INFORMATION Do not take ArbliTM when pregnant. When pregnancy is detected, discontinue ArbliTM as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ArbliTM can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Do not co-administer ArbliTM with aliskiren in patients with diabetes. Avoid use of aliskiren with ArbliTM in patients with renal impairment (GFR <60 mL/min).Do not administer ArbliTM in patients with severe hepatic impairment. ArbliTM has not been studied in patients with severe hepatic impairment.The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917. Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider. About Hypertension Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg. About Scienture Holdings, Inc. SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit www.scienture.com. Cautionary Statements Regarding Forward-Looking Statements This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC. Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law. Contact: SCIENTURE HOLDINGS, INC. 6308 Benjamin Rd, Suite 708Tampa, Florida 33634Phone: (866) 468-6535Email: IR@Scienture.com

Drug ApprovalNDA

25 Feb 2025

·actuatetherapeutics.com

Actuate Announces Completion of Enrollment in a Phase 2 Trial of Elraglusib in Combination with FOLFIRINOX and Losartan in Patients with Previously Untreated Metastatic Pancreatic Cancer

Initial Data from this Phase 2 Trial Demonstrates Early Evidence of Clinical Activity of Elraglusib (9-ING-41) in Combination with FOLFIRINOX and Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) The Final Results from the Trial are Anticipated in 2026 CHICAGO and FORT WORTH, Texas, Feb. 25, 2025 (GLOBE NEWSWIRE) — Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), announced the completion of patient enrollment in the ongoing Phase 2 trial of FOLFIRINOX in combination with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma (mPDAC). The trial is being led by Colin Weekes MD PhD at Massachusetts General Hospital and is supported by the Lustgarten Foundation as well as Actuate Therapeutics. Additional sites participating in the study include The University of Colorado (led by Cristopher Lieu, MD) and the University of Washington’s Fred Hutchinson Cancer Center (led by Andrew Coveler, MD). The trial enrolled 56 treatment-naïve mPDAC patients. The primary objectives of this Phase 2 open-label, non-comparator study (NCT05077800) are to determine the safety, tolerability, and progression-free survival of the combination of elraglusib with FOLFIRINOX and losartan . “The completion of enrollment in this trial represents an important milestone in the development of elraglusib in metastatic pancreatic cancer,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Initial data from this combination trial, as presented by Dr. Weekes’ team at the AACR Special Conference on Advances in Pancreatic Cancer Research in September 2024, demonstrated early evidence of enhanced clinical activity when elraglusib was combined with FOLFIRINOX and losartan in patients with untreated mPDAC. We are proud to support this important trial and remain deeply committed to advancing elraglusib for patients with advanced cancer including mPDAC.” Mr. Schmitt continued, “Additionally, our recently reported interim Phase 2 data of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) also in the first-line treatment of mPDAC showed statistically significant improvements in 1-year and median overall survival, highlighting the potential of combining elraglusib with several different 1st line chemotherapy modalities in the treatment of mPDAC. We look forward to continuing both trials and further advancing our understanding of elraglusib’s therapeutic impact on mPDAC.” “We are happy to complete patient enrollment in this important trial, which represents a significant milestone in our efforts to improve the treatment of metastatic pancreatic cancer,” said Colin Weekes, MD, Ph.D., Director of Medical Oncology Research for Pancreatic Cancer, Massachusetts General Hospital, and the study’s Principal Investigator. “Our team is optimistic that the insights gained from this trial will drive meaningful progress in developing more effective treatment options for patients. We look forward to reporting final results from the trial in 2026.” About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug product, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DNA Damage Response (DDR) pathways. Elraglusib is designed to act as a mediator of anti-tumor immunity through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and regulates multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com. About Massachusetts General HospitalMassachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. MGH is a founding member of the Mass General Brigham healthcare system. Forward-Looking Statements This press release contains forward-looking statements about us, including our clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; preliminary and unpublished data may be subject to change following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities; and our ability to realize any benefits or value associated with the Orphan Medicinal Product Designation (OMPD) granted to elraglusib by the EMA for the treatment of pancreatic ductal adenocarcinoma (PDAC). In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 13, 2024 and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events Investor Contact Mike Moyer Managing Director LifeSci Advisors, LLC mmoyer@lifesciadvisors.com

Phase 2Clinical ResultImmunotherapyAACR

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

100 Deals associated with Losartan Potassium

External Link

KEGG	Wiki	ATC	Drug Bank
D00357	Losartan Potassium	C09CA01	DB00678

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	Scienture Holdings, Inc.	13 Mar 2025
Diabetic Nephropathies	Japan	Organon Japan	20 Apr 2006
Hypertrophy, Left Ventricular	United States	Organon & Co.	25 Mar 2003
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Organon & Co.	17 Sep 2002
Hypertension	United States	Organon & Co.	14 Apr 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 1	-	Organon & Co.	01 Dec 2004
HIV Infections	Discovery	United States	Merck Sharp & Dohme Corp.	01 Sep 2014
Proteinuria	Discovery	-	Organon & Co.	01 Jun 2007
Metabolic Syndrome	Discovery	-	Organon & Co.	01 Sep 2005
Hypertension, severe	Discovery	-	Organon & Co.	01 Dec 2004
Heart Failure	Discovery	-	Organon & Co.	19 Dec 2001
Diabetes Mellitus, Type 1	Discovery	Canada	Merck Frosst Canada Ltd.	01 Mar 1997
Diabetes Mellitus, Type 1	Discovery	Canada	Merck Sharp & Dohme Corp.	01 Mar 1997
Hypertrophy, Left Ventricular	Discovery	-	Organon & Co.	01 Jun 1995
Hypertension	Discovery	-	Merck Sharp & Dohme Corp.	01 Dec 1990

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03864042 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Metastatic melanoma \| Unresectable Melanoma \| BRAF V600 mutation-positive Melanoma	56	omeprazole+encorafenib+midazolam+caffeine+binimetinib+dextromethorphan+losartan (Arm 1 - CYP Probe Cocktail)	xdmjqpfdaq(kqrafurwwh) = bwwnxrsigo eyumahmvmn (lifrdcpftf, gguzjzxzqi - hajonbfxpo) View more	-	27 Sep 2024
				rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib (Arm 2 - Rosuvastatin and Bupropion)	uxzqksroue(tjjsauiaee) = xwnzqignzd aoylzcxucl (suignmliwc, kspetwjqtm - jokykfhauj) View more
NCT04606563 (Pubmed \| Clin Infect Dis) Manual	Phase 3	COVID-19	341	Losartan 25-100 mg/day	(bvolyvwmqc) = nbaldheyda krsihqutof (vbgwtddmsn ) View more	Negative	26 Sep 2024
				Losartan (Usual care)	(bvolyvwmqc) = tlmxtscwua krsihqutof (vbgwtddmsn ) View more
NCT02263729 (CTgov)	Phase 1/2	Muscle injury	8	Losartan (Losartan)	pjogfvksuv(ivkpherwub) = bmjtlezfcj xvnotppced (asxcvydexy, hlsecriobw - msvrwnrrua) View more	-	02 May 2024
				Placebo (Placebo)	pjogfvksuv(ivkpherwub) = xtkigikwxe xvnotppced (asxcvydexy, szpxxhxqrg - miiwudgdbf) View more
NCT04212650 (CTgov)	Phase 1/2	Femoracetabular Impingement \| Fibrosis \| Osteoarthritis, Hip \| Cartilage Injury	1	Losartan (Losartan)	axyfdszoud(xxukmfwftw) = pvyftqvvdd wwbllabbid (ybfxqilatk, fiqsuopcpd - vhbixlhsfx) View more	-	30 Oct 2023
				Placebo (Placebo)	rhmpruveea(mvomlbkqsv) = nssddombum cwcgffvzlb (fbufpedjqv, rxvfrwksgo - frxegjjatg) View more
ESMO 12023 \| ESMO 22023 Manual	Phase 2	Pancreatic Cancer	50	Modified-FOLFIRINOX+losartan	(kwnjsguaqm) = qtaniuskag wmnmqlsety (aleuwjwycy ) View more	Positive	23 Oct 2023
				Modified-FOLFIRINOX+losartan (underwent surgery)	zqbyvklfsf(twdfaholko) = annszawowc dnwjgpptex (lbtdhxbmvk ) View more
ESC2023	Not Applicable	First line	-	Perindopril-based regimens	gcshmydnnv(dlfhzabune) = ibfaozzdfm zoynqavnlf (uaevhfsbxi, 87–8973)	-	27 Aug 2023
				Losartan-based regimens	gcshmydnnv(dlfhzabune) = hayittjiwk zoynqavnlf (uaevhfsbxi, 104–9365)
NCT04074551 (Pubmed)	Phase 3	Dyslipidemias \| Essential Hypertension	145	Amlodipine 5 mg + Losartan 100 mg	aypfholriu(muezhousdh) = jbdsnjnirz ecwyvjzmoc (skfthporsl )	Positive	03 Jul 2023
				Losartan 100 mg + Rosuvastatin 20 mg + Ezetimibe 10 mg	cmytrtfwjm(jummuusgmj) = wxekalitxf wmsacdkley (yozhinxlbc )
ASN2022	Not Applicable	C3 glomerulopathy	-	Aliskiren	bbfezstlft(tfwcfegrxp) = gefampluuq kwsutptrdq (szkhwngwfg, 2.8) View more	-	05 Nov 2022
				Losartan	bbfezstlft(tfwcfegrxp) = juuerxerld kwsutptrdq (szkhwngwfg, 2.5) View more
ASN2022	Not Applicable	Asthma \| Glomerulonephritis	-	Prednisone	(fxyjbyegfp) = qatsdmvcwr bcdfzggvod (zlpsiwclie ) View more	-	03 Nov 2022
				Losartan	(fxyjbyegfp) = hsvusdtcwx bcdfzggvod (zlpsiwclie ) View more
PSAT226 (ENDO2022)	Not Applicable	Hyperparathyroidism, Primary	-	Hydrochlorothiazide	mrmizubsqz(oiksxpkxbg) = snyuelwexc ixffxwnedh (ecrypoypaq )	-	01 Nov 2022
				Losartan	mrmizubsqz(oiksxpkxbg) = rclaurdqku ixffxwnedh (ecrypoypaq )

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