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Last update 12 Nov 2025

Acarbose

Last update 12 Nov 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Acarbose (JAN/USAN/INN), BAY-G-5421, Bay g 5421

+ [7]

Target

AMYs x GANC x MGAM x α-glucosidase

Action

inhibitors

Mechanism

Alpha amylases inhibitors, GANC inhibitors(glucosidase alpha, neutral C inhibitors), MGAM inhibitors(Maltase-glucoamylase inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2Hyperglycemia

Inactive Indication

Glucose Intolerance

Originator Organization

Bayer AG

Active Organization

Bayer Yakuhin Ltd.

Shanghai Shyndec Pharmaceutical Co., Ltd.

Arrotex Pharmaceuticals Pty Ltd.

+ [1]

Inactive Organization

Bayer AGEMS SA (Brazil)

Chengdu Hengrui Pharmaceutical Co. Ltd.

+ [1]

License Organization

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

Germany (01 Jan 1990),

Diabetes Mellitus, Type 2

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC25H43NO18

InChIKeyCEMXHAPUFJOOSV-XGWNLRGSSA-N

CAS Registry56180-94-0

170

Clinical Trials associated with Acarbose

NCT05487859

/ Not yet recruitingPhase 2IIT

A Pilot Study of the Immunomodulatory Agent Acarbose in Combination with Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)

The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients.

Start Date31 Dec 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT07074379

/ Not yet recruitingNot ApplicableIIT

Endotherapy and/or Extracorporeal Shockwave Lithotripsy Versus Conservative Treatment in Painless Chronic Pancreatitis

Chronic pancreatitis (CP) is caused by factors such as genetics and the environment, leading to the destruction of pancreatic tissue, infiltration of inflammatory cells, and progressive fibrosis of the pancreas. As the disease progresses, pancreatic tissue is damaged, resulting in impaired endocrine and exocrine functions, manifesting as symptoms like steatorrhea and diabetes. Pain associated with chronic pancreatitis (PACP) is the most common symptom in CP patients. Approximately 75% of patients initially present with abdominal pain, and previous studies have shown that PACP can occur in 85-97% of CP patients. However, there is a type of pancreatitis where patients do not experience abdominal pain and typically seek medical attention due to routine check-ups or symptoms of pancreatic endocrine and exocrine dysfunction; this particular type of pancreatitis is known as painless CP. A meta-analysis showed that painless CP accounts for about 12% of all CP patients.
In patients with CP, continuous pancreatic damage leads to the destruction of pancreatic tissue, subsequently causing insufficiency in both exocrine and endocrine functions. "Painless" does not equate to "harmless"; patients with painless CP often present with severe symptoms of pancreatic exocrine and endocrine dysfunction at the time of diagnosis. These findings underscore the importance of early identification and active management of patients with painless CP.
Whether active endoscopic intervention is needed for painless CP remains a matter of debate. The European Society of Gastrointestinal Endoscopy (ESGE) suggests endoscopic therapy and/or extracorporeal shockwave lithotripsy (ESWL) as the first-line therapy for painful uncomplicated chronic pancreatitis (CP) with an obstructed main pancreatic duct (MPD) in the head/ body of the pancreas; however, due to the unclear potential benefits (preservation of pancreatic function) of endoscopic and/or ESWL treatment for painless CP, it is not recommended for patients without pain, although the evidence is of low quality.
Although there is currently no consensus on whether endoscopic treatment can protect the pancreatic function of patients with painless chronic pancreatitis, preliminary evidence suggests that endoscopic treatment may have a positive impact on pancreatic atrophy and dysfunction in patients with painless CP. In a retrospective study by Ikeura et al., which included 268 patients with CP and painless pancreatic duct stones, it was found that endoscopic treatment and complete clearance of stones in patients with painless pancreatic duct stones helped maintain the volume of the pancreatic parenchyma.
Although preliminary research suggests that endoscopic treatment may protect pancreatic function in patients with painless CP, it could also trigger pain. A study by Ikeura et al. found that painless CP patients who underwent endoscopic treatment but did not have complete clearance of pancreatic duct stones were at a significantly higher risk of developing pain. This indicates that incomplete endoscopic treatment might lead patients from a painless state to one of pain. However, a study by Amodio et al. suggests that the likelihood of painless CP patients experiencing pain in the short term is low, implying that conservative treatment might be more appropriate.
Current research on the clinical characteristics of painless CP and its response to treatment is relatively limited, necessitating further clinical studies to clarify the impact of ERCP and/or ESWL on these patients. We plan to conduct a randomized controlled trial to assess whether these minimally invasive interventions can improve clinical outcomes for patients with painless CP

Start Date21 Jul 2025

Sponsor / Collaborator

Changhai Hospital of Shanghai

ChiCTR2500108461

/ Not yet recruitingPhase 4IIT

A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin versus Acarbose in Drug-Naïve Patients with Type 2 Diabetes

Start Date01 Apr 2025

Sponsor / Collaborator

Henan Provincial Peoples Hospital

[+2]

100 Clinical Results associated with Acarbose

100 Translational Medicine associated with Acarbose

100 Patents (Medical) associated with Acarbose

5,784

Literatures (Medical) associated with Acarbose

01 Jan 2026·BIOPHYSICAL CHEMISTRY

In silico and in vitro characterization of Phytolacca latbenia (Moq.): QSAR, phytochemical, and toxicological insights into antiglycation and antidiabetic potential

Article

Author: Zargaham, Muhammad Kazim ; Ross, Samir Anis ; Kamran, Muhammad ; Khalid, Tooba ; Rafey, Hafiz Abdul ; Amin, Adnan ; Niaz, Shah-Iram

Diabetes and the related comorbidities have been associated with elevated levels of advanced glycation end products (AGEs). The biochemical process of advanced glycation, is believed to be playing a pivotal role in the development of complications. Since there exists a great deal of promise for natural products offering antidiabetic potential, we studied advanced glycation inhibition and anti-diabetic profile of Phytolacca latbenia (Moq). on fractions and the sorted compounds based on the QSAR and molecular docking analysis. The top two bioactive compounds; Kaempferol and Esculentoside G, were further evaluated for the MD simulation studies at 150 ns run, compared with the standard. Among the tested compounds, Kaempferol presented significant binding energies in MM-GBSA (-48.63 Kcal/mol) and MD simulation studies (73 %) with transcriptional regulator 4F5S. Molecular docking studies revealed that kaempferol formed three hydrogen bonds with Val342, Ser343 and Ser453, along with Pi-Pi stacking and Pi-cation interactions with Trp213 and Arg217 residues of the 4F5S protein. Kaempferol also displayed significant α-glucosidase inhibition (IC₅₀ 0.042 ± 2.31 μg/ml) compared to the acarbose (IC₅₀ 0.036 ± 0.31 μg/ml). Almost all of the selected compounds demonstrated adherence to the safety requirements established by ADMET investigation. Liquid-liquid partitioning of the crude methanolic extract with solvents of increasing polarity yielded five solvent fractions;the ethyl acetate fraction (ETOA) obtained by liquid-liquid partitioning of the crude extract with ethyl acetate and water proclaimed substantial results in both the non-oxidative (61 %) and oxidative (58 %) antiglycation assays for thiol group estimation. The ethylacetae fraction (ETOA) demonstrated comparatively strong antioxidant activity, with an IC₅₀ value of 13.25 ± 0.69 μg/ml as determined by the DPPH assay. In α-glucosidase assay, Aqueous fraction demonstrated a considerable inhibition with IC₅₀ value of 0.108 ± 0.32 μg /ml compared to the standard (IC₅₀ 0.083 ± 0.43 μg/ml). The safety assessment revealed a slight decline in HeLa cell viability, dropping from 82 % at a 2.5 % concentration to 69 % at a 10 % concentration over 24 h, relative to the control.Therefore, Phytolacca latbenia (Moq). and its phytocompounds tested inhibit α-glucosidase and Advanced glycation end product-the process that underlie diabetic complications and may therefore holds great promise as therapeutic agent, with no toxicity concern,against diabetes and related comorbidities.

01 Jan 2026·TALANTA

Crosstalk-free dual-mode biosensing in a single MOF for α-glucosidase activity monitoring and inhibitor screening

Article

Author: Shen, Qian-Wen ; Hao, Shuo ; Li, Qing ; Tan, Kai-Yu ; Zhu, Chao-Jie ; He, Xiang-Yi

This study presents a novel crosstalk-free dual-mode biosensing platform based on a single cerium-incorporated metal-organic framework (UiO-66-NH₂(Ce)) for sensitive detection of α-glucosidase activity and inhibitor screening. Unlike traditional dual-mode systems affected by signal interference, this monolithic MOF platform intrinsically produces orthogonal colorimetric and fluorescent responses. Upon α-glucosidase-mediated generation of hydroquinone, simultaneous signal transduction occurs through independent pathways: colorimetric attenuation via suppression of the oxidase-like catalytic process, and fluorescence recovery due to ligand-to-metal charge transfer modulation. Rigorously optimized for clinical application, the platform achieves ultra-low detection limits of 0.0166 U/L in colorimetric mode and 0.0094 U/L in fluorescent mode, surpassing existing methods. The platform demonstrates selectivity against potential interferents and successfully quantifies α-glucosidase in human serum with satisfactory recovery rates. Furthermore, the system facilitates precise inhibitor screening with IC₅₀ values of 8.13 μM for fluorescence-based detection and 10.06 μM for colorimetric detection of acarbose. By integrating self-validating detection and drug evaluation within a single-material architecture, this work establishes a paradigm for designing robust MOF-based biosensors equipped with built-in cross-validation capabilities.

01 Jan 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Harnessing benzofuran scaffolds: A journey through design, synthesis, and biological discovery toward safer anti-diabetic and anti-oxidant candidates

Article

Author: Ismail, Rania S M ; Ghabbour, Hazem A ; Abdel-Aziz, Hatem A ; Naglah, Ahmed M ; Almehizia, Abdulrahman A ; Fakhry, Mariam M ; Ibrahim, Aya Mohamed Ahmed ; Alkabbani, Mahmoud Abdelrahman ; Eldehna, Wagdy M ; Tawfik, Haytham O ; Elkotamy, Mahmoud S ; Hamdy, Abdallah M ; Abubakr, Abdelhameed ; Shatat, Abdel-Aziz S ; Mohamed, Mayada H ; Elgohary, Mohamed K

A series of benzofuran-based compounds 7a-e, 8a-e, 13a-c, and 17a-e was designed and synthesized through bioisosteric strategies inspired by previously reported studies. These compounds were initially screened for anti-oxidant properties using the DPPH radical scavenging assay, where compounds 8c, 8d, 8e, 13c, and 17d demonstrated outstanding activity, with IC₅₀ values ranging between 13.48 and 21.73 μM. Subsequent enzymatic assays demonstrated that compounds 7d, 8d, 17c, and 17e exhibited α-amylase inhibitory activity comparable to the reference drug acarbose (IC₅₀ = 12.35-24.59 μM). In parallel, compounds 7e, 8e, and 17c showed potent α-glucosidase inhibition, with IC₅₀ values ranging from 7.30 to 15.24 μM, which are comparable to or surpass the activity of acarbose (IC₅₀ = 11.29 ± 0.10 μM), supporting their potential as anti-diabetic agents. Building upon these in vitro findings, selected candidates were evaluated in vivo using glucose intolerance and alloxan-induced diabetic models, where they significantly lowered blood glucose levels compared to standard treatments. Complementary bioinformatics studies confirmed the engagement of key anti-diabetic molecular targets. Safety was assessed via toxicity biomarkers (AST, ALT, creatinine, and urea), all of which remained within normal ranges, indicating a favorable toxicity profile. ADME analyses suggested good oral bioavailability and low risk of systemic toxicity. Additionally, molecular docking and molecular dynamics simulations demonstrated strong binding affinities and structural alignment with co-crystallized ligands. These findings collectively establish the benzofuran scaffold as a promising platform for developing novel anti-oxidant and anti-diabetic therapeutics.

News (Medical) associated with Acarbose

23 Oct 2023

·synapse.patsnap.com

Advances in Clinical Research on Amylase Inhibitor

Amylase is an essential enzyme found in the human body that plays a crucial role in the digestion of carbohydrates. Produced primarily in the salivary glands and pancreas, amylase breaks down complex starch molecules into simpler sugars like glucose, maltose, and dextrin. This process begins in the mouth, where salivary amylase initiates the breakdown of starches into smaller fragments. Once in the stomach, the enzyme continues its action until it reaches the small intestine, where pancreatic amylase takes over to complete the digestion process. Without amylase, the body would struggle to efficiently convert carbohydrates into usable energy, leading to potential digestive issues and nutrient deficiencies. Amylase Competitive LandscapeAccording to Patsnap Synapse, as of 27 Sep 2023, there are a total of 5 amylase drugs worldwide, from 6 organizations, covering 7 indications, and conducting 1 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. Based on the analysis of the provided data, the current competitive landscape of target amylase indicates that companies like Anagram Therapeutics, Inc. and Propanc Biopharma, Inc. are growing rapidly in their R&D efforts. Drugs targeting amylase have been approved for indications such as Exocrine Pancreatic Insufficiency, Neoplasms, Ovarian Cancer, Solid Tumors, Pancreatic Cancer, Malabsorption Syndromes, and Gastrointestinal Diseases. Enzyme-based drugs and small molecule drugs are progressing rapidly, indicating potential competition around innovative drugs. The countries/locations with significant development in target amylase include the United States, European Union, Australia, Spain, France, Denmark, and Belgium. However, the progress in China cannot be determined based on the provided data. Overall, the target amylase market shows promising growth potential with active R&D efforts and a diverse range of indications and drug types. Key drug: AcarboseAcarbose is a small molecule drug that falls under the therapeutic areas of endocrinology and metabolic disease. It is primarily used for the treatment of diabetes mellitus, specifically type 2 diabetes. The drug targets several enzymes including alpha-amylase, GANC, MGAM, and α-glucosidase. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The originator organization of Acarbose is Bayer AG, a well-known pharmaceutical company. The drug has reached the highest phase of approval globally, indicating its successful development and regulatory progress. Acarbose received its first approval in the United States in September 1995, making it available to patients in that country. One notable aspect of Acarbose is its regulation status, which is classified as priority review. This suggests that the drug has undergone an expedited evaluation process by regulatory authorities, possibly due to its potential benefits and urgency in addressing the medical needs of patients with type 2 diabetes. Acarbose's mechanism of action involves inhibiting the enzymes targeted, which play a role in the digestion and absorption of carbohydrates. By inhibiting these enzymes, Acarbose helps to slow down the breakdown of complex carbohydrates into simple sugars, thereby reducing the postprandial rise in blood glucose levels. This mechanism makes Acarbose a valuable treatment option for individuals with type 2 diabetes, as it helps to control their blood sugar levels. In summary, Acarbose is a small molecule drug developed by Bayer AG for the treatment of type 2 diabetes. It targets multiple enzymes involved in carbohydrate digestion and absorption, and its regulatory status as a priority review drug highlights its potential significance in managing this metabolic disease. Acarbose received its first approval in the United States in 1995 and has since been approved in other countries, including China. Its successful development and regulatory progress make it a valuable addition to the pharmaceutical industry's arsenal in combating diabetes mellitus.

17 Jun 2022

·www.prnewswire.com

Generic Pharmaceuticals Global Markets Report 2022-2026 & 2031: Biosimilar; Simple Generic and Super Generic

DUBLIN, June 17, 2022 /PRNewswire/ -- The "Generic Pharmaceuticals Global Market Report 2022: By Therapy, By Distribution, By Type, By Drug" report has been added to ResearchAndMarkets.com's offering. The global generic pharmaceuticals market is expected to grow from $302.39 billion in 2021 to $332.43 billion in 2022 at a compound annual growth rate (CAGR) of 9.9%. The market is expected to reach $426.30 billion in 2026 at a CAGR of 6.4%. The generic pharmaceuticals market consists of sales of generic pharmaceuticals. A generic medicine is a medication designed to be identical as branded drugs marketed by private companies in dosage form, strength, safety, route of administration, performance characteristics, quality, and intended use. Generic drugs work in the same way as branded drugs in terms of clinical benefits. Generic drugs are manufactured after the expiration of the exclusive rights or patent of the branded drugs. For example, some of the generic drugs in the generic pharmaceuticals market include metformin, metoprolol, acarbose, acebutolol, aztreonam and many more. The main types of generic pharmaceuticals are biosimilar; simple generic and super generic. A biosimilar is a biological product that is very similar to a reference biologic and has no clinically significant differences in terms of safety, purity, or potency. The drugs are delivered through oral, injectables, dermal/topical and inhaler that are used for various therapies such as CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes and oncology. The various distribution channel involved are hospital pharmacies, retail pharmacies and online pharmacies. North America was the largest region in the generic pharmaceuticals market in 2021. Middle East is expected to be the largest growing region in the forecast period. The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The rising incidence of chronic diseases is one of the major drivers of the generic pharmaceuticals market. As more individuals are diagnosed with chronic diseases, they look for more medicines for the treatment. Branded drugs come at a premium price, while generic drugs are available at a lower cost having the same chemical composition of branded drugs. The low cost and same chemical composition and strength of generic drugs make a patient buy generic drugs instead of branded drugs. If it is a chronic disease, the treatment goes for a longer period of time and hence, the sales of generic drugs also increase. For instance, according to the WHO (World Health Organization), over the next 10 years, the deaths due to chronic disease is projected to increase by 17%. Also, in 2020, almost 3-quarters of all deaths in the world is due to chronic diseases. The lack of awareness about generic drugs is one of the restraints on the generic pharmaceuticals market. The high marketing and advertisement of branded drugs overshadow the availability of generic drugs which are substitute for expensive branded drugs. Thus, consumers opt branded drugs despite the fact that the generic drugs carry the same chemical formulation as their counter branded drugs. According to an article published on CVS HEALTH, many doctors and pharmacists preferred to offer branded drugs to their patients over generic drugs. This prevents the patients to go for generic drugs as they develop a preconceived notion of generic drugs not being at par with branded drugs. For example, according to a research conducted by Sahana K Hebbar, on International Journal of Basic & Clinical Pharmacology, out of 100 patients and 50 non-medical staff, 95% of the patients and 60% of the non-medical staff didn't know about generic drugs. Thus, lack of awareness about the availability of generic drugs hamper the generic pharmaceuticals market. 3D printing technology has the ability to transform the manufacturing of drugs in the generic pharmaceuticals market. 3D printed pharmaceuticals help in improve R&D productivity and deliver new benefits to patients. 3D printing allows the manufacturer to produce drugs with customized size, shape, and texture which is not possible in traditional manufacturing of generic drugs. 3D printing can help the manufacturer to make generic drugs that have different release dates, appearances and taste. For example, GlaxoSmithKline (GSK) completed a study where ultraviolet (UV) and 3D printing were used to manufacture tablets to treat Parkinson's disease. Martin Wallace, director of GSK Technology, said that GSK is investing in 3D printing advantages to manufacture pills and tablets. Also, Aprecia pharmaceutical company launched 'ZipDose' technology which manufactures 3D printed drugs. The drug manufacturers must comply with the CGMP (Current Good Manufacturing Practice) regulations that come under the US Food and Drug Administration (FDA) which includes generic pharmaceuticals. The CGMP regulations require manufacturers to maintain a minimum quality standard for the methods, controls, and facilities used in manufacturing, packaging, and processing of drug product. The part- 99 of chapter 1 under title 21-Food And Drugs of CFR (Code of Federal Regulations) contains subparts from A to H. The whole part-99 describes the guidelines that need to be followed by drug manufacturers regarding the dissemination of information on human drugs, including biologics, and devices. The guidelines concern with the safety, effectiveness, or benefit of use that is not included in the approved labelling for a drug or device approved by the Food and Drug Administration for marketing. The guidelines regulate the information regarding the drugs that should be delivered to the health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or federal or state government agency. Generic Pharmaceuticals Market Competitive Landscape And Company Profiles Teva Pharmaceuticals Mylan NV Sandoz International GmbH Hospira (Pfizer inc.) Sun Pharmaceutical Lupin Limited Endo International plc. Dr Reddy's Laboratories Apotex Holdings Fresenius Kabi Ag Aurbindo Pharma Aspen Pharmacare Sanofi Cipla Hikma Pharmaceuticals Stada Arzneimittel Krka Group Nichi-Iko Pharmaceutical Valeant Zydus Cadila Merck & Co. Mitsubishi Tanabe Pharma Momenta Pharmaceuticals Nexus Pharmaceuticals Novo Nordisk Ranbaxy Laboratories Ltd. Sawai Pharmaceuticals Novartis AG Pfizer Johnson & Johnson Services Key Topics Covered: 1. Executive Summary 2. Generic Pharmaceuticals Market Characteristics 3. Generic Pharmaceuticals Market Trends And Strategies 4. Impact Of COVID-19 On Generic Pharmaceuticals 5. Generic Pharmaceuticals Market Size And Growth 5.1. Global Generic Pharmaceuticals Historic Market, 2016-2021, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Generic Pharmaceuticals Forecast Market, 2021-2026F, 2031F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market 6. Generic Pharmaceuticals Market Segmentation 6.1. Global Generic Pharmaceuticals Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion CNS Cardiovascular Dermatology Genitourinary/Hormonal Respiratory Rheumatology Diabetes Oncology 6.2. Global Generic Pharmaceuticals Market, Segmentation By Distribution Channel, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Hospital Pharmacies Retail Pharmacies Online Pharmacies 6.3. Global Generic Pharmaceuticals Market, Segmentation By Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Biosimilar Simple Generic Super Generic 6.4. Global Generic Pharmaceuticals Market, Segmentation By Drug Delivery, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Oral Injectables Dermal/Topical Inhaler 7. Generic Pharmaceuticals Market Regional And Country Analysis 7.1. Global Generic Pharmaceuticals Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion 7.2. Global Generic Pharmaceuticals Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Generic DrugBiosimilar

26 Aug 2021

·endpts.com

BioDuro-Sundia plants its flag at former Par manufacturing site in CA

A former Par Pharma site in Irvine, CA, will now have a new tenant. BioDuro-Sundia will acquire a 40,000-square-foot oral solid dose manufacturing site in Irvine, the company announced Monday. The site will allow the company to scale up and cater to companies that need larger-scale production, Kent Payne, the president of development and manufacturing, said in a press release. The new site should be operational by the start of 2022. It will be able to produce 1 billion tablets and capsules a year, the company said. “BioDuro-Sundia is a pioneer in enhancing bioavailability, with 25 years of experience applying stabilized amorphous solid dispersion technology to poorly soluble drug product candidates,” he said. “Our clients have requested our support to provide commercial scale manufacturing to save time and maximize success, and it is a pleasure to take this next step with them.” BioDuro-Sundia is a CDMO with 2,000 employees in 10 sites across the country, including China and the US. The company specializes in small- and large-molecule discovery, IND submission support and the scaling of batches. It bills itself as a one-stop shop for its clients. The site is located at 72 Fairbanks in Irvine and was previously used by Par Pharmaceuticals. They acquired the site from Anchen Pharmaceuticals back in 2011, when they acquired the company. In 2020, BioDuro invested in a 150,000-square-foot R&D site in Wuxi City, China, and says that the integrated system can help save time and produce a better quality drug. In April, the company invested in adding a cGMP manufacturing site at the facility. That location handles oral dosage tablets and capsules. That added to its already-existing site in San Diego. Among the drugs manufactured by the company is Gliclazide, a sustained release tablet to treat diabetes from Tianjin Jun’an Bio. The drug is often used with metformin tablets, acarbose tablets or pioglitazone.

100 Deals associated with Acarbose

External Link

KEGG	Wiki	ATC	Drug Bank
D00216	Acarbose	A10BF01	DB00284

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Germany	-	01 Jan 1990

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Glucose Intolerance	Phase 3	Spain	Bayer AG	01 Aug 2000
Hyperglycemia	Phase 1	China	Shanghai Shyndec Pharmaceutical Co., Ltd.	08 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2000039424 (Pubmed) Manual	Phase 4	Diabetes Mellitus, Type 2	701	Metformin combined with Acarbose 100 mg	opeqheqqid(kocwvqwwng) = tfnipawfll lonimjavci (uewfuocxnt ) View more	Positive	05 May 2025
				Metformin combined with Sitagliptin 100 mg	opeqheqqid(kocwvqwwng) = ucjxmzsbng lonimjavci (uewfuocxnt ) View more
NCT02999841 (Pubmed \| Diabetologia)	Phase 4	Diabetes Mellitus, Type 2	-	Acarbose	zfrjlovqob(mpkpnzhbvq) = common reductions mahcmfenjr (npnorddmvl )	-	01 Oct 2022
				Vildagliptin
NCT01490918 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	165	Placebo acarbose (Acarbose Placebo, Metformin, Sitagliptin)	kyyjwyhgyw(grotralyah) = tjmijnedzl usrusacick (hkcfhpxarg, qtzezfbjrm - yzaoevbcws) View more	-	17 Aug 2020
				Acarbose (Sitagliptin, Metformin, Acarbose)	kyyjwyhgyw(grotralyah) = kyktymyqng usrusacick (hkcfhpxarg, zkdxrdzsjd - okwzklvsng) View more
NCT00829660 (ACE, Pubmed \| Diabetes Care)	Phase 4	Coronary Artery Disease	6,526	Acarbose	rrcbvwiqdz(rafznvhydf) = pchmtpybwa wiaawnqkbj (xkowxrfqnr ) View more	Positive	08 Jul 2020
				Placebo	rrcbvwiqdz(rafznvhydf) = mtbiokfcwl wiaawnqkbj (xkowxrfqnr ) View more
NCT01181674 (REMIT Pilot, CTgov)	Phase 4	Diabetes Mellitus, Type 2	83	insulin glargine+metformin+acarbose (Group 1 (Short))	ibxnhofnmu = iermlrekvz ptoixvczic (oripkmityz, cmhauhyxqh - qkqihxcymt) View more	-	21 May 2020
				insulin glargine+metformin+acarbose (Group 2 (Long))	zhxelydnmn = bgefygajmc riikpqlzbi (wdmfxtchih, uveivflejd - uspygnstvu) View more
NCT00829660 (ACE trial, EASD2019)	Phase 4	Coronary Disease fasting plasma glucose \| 2 hour post load plasma glucose	6,522	Acarbose	varaivqovr(zahejhwswf) = rpkfiaupwx ilhhziqvep (gsrywhvcko )	Positive	18 Sep 2019
NCT02865499 (CTgov)	Phase 2	disorder of aging	8	acarbose	hqtvjkldqq = gkcxxxsjwa qpemfizbkw (lziarwiqna, slvucrdlag - gvpaloiugo) View more	-	14 Mar 2019
ChiCTR-IPR-14005716 (EASD2018)	Phase 4	Diabetes Mellitus, Type 2	648	Saxagliptin plus Acarbose	whkwsimpvy(lxtqtyzqza) = Hypoglycemic events, almost all are mild, were reported during treatment period in acrabose (0.38%), gliclazide MR (1.42%), and metformin (0.68%) cltsosocxf (fiqyttfyah )	Positive	03 Oct 2018
				Saxagliptin plus Gliclazide MR
ACTRN12618000152224 (EASD2018)	Phase 4	-	10	acarbose (Control treatment)	swwasbkjzk(jkhydcdocm) = faujnbdjzy vyarycpkei (mibqhzgmvp )	Positive	02 Oct 2018
				acarbose (Distension treatment)	swwasbkjzk(jkhydcdocm) = lvuhhjkwfy vyarycpkei (mibqhzgmvp )
ISRCTN91899513 (ACE, EASD2018)	Phase 4	Glucose Intolerance	-	Acarbose	igsqzuytib(ahawfjfaxy) = ypbylbgrfb xefpgoarmy (ypdcuzrgbl, 6.08) View more	Negative	02 Oct 2018
				Placebo	igsqzuytib(ahawfjfaxy) = cawsicogtp xefpgoarmy (ypdcuzrgbl, 6.99)

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