Delving into the Latest Updates on Metformin Hydrochloride with Synapse

Overview

Basic Info

SummaryMetformin Hydrochloride, sold under the trade name GLUCOPHAGE, is a medication used in the treatment of type 2 diabetes mellitus. It was first approved in France in 1957 and is now manufactured by Bristol Myers Squibb Co. GLUCOPHAGE works by activating PRKAB1, which helps to improve glycemic control in both adult and pediatric patients aged 10 years and older, when used in combination with diet and exercise. This medication is a biguanide, and it is commonly used as an adjunct therapy to help manage blood sugar levels in individuals with type 2 diabetes.

Drug Type

Small molecule drug

Synonyms

Meiformin Hydrochloride, Metformin hydrochloride (JP17/USP), Metformin Hydrochlorride

+ [67]

Target

PRKAB1

Action

activators

Mechanism

PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic DiseaseNeoplasmsImmune System Diseases+ [12]

Active Indication

Diabetes MellitusDiabetes Mellitus, Type 2Invasive Mammary Carcinoma+ [48]

Inactive Indication

Acinar Cell CarcinomaAcquired Immunodeficiency SyndromeAdenocarcinoma of large intestine+ [70]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

National Cancer Institute

Curative Biotechnology, Inc.

NRG Oncology

+ [30]

Inactive Organization

National Institute of Diabetes & Digestive & Kidney Diseases

University of Arizona

National Institute on Aging

+ [21]

License Organization

Merck KGaA

The Fox Chase Cancer Center

Sylvester Comprehensive Cancer Center

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1992),

Diabetes Mellitus, Type 2

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS Registry1115-70-4

This is a double blinded, randomized, placebo controlled clinical trial of 40 participants with pulmonary sarcoidosis.
Primary Objective: To assess the steroid-sparing efficacy and safety of oral metformin therapy in participants with confirmed progressive pulmonary sarcoidosis for participants with steroid dependent disease.

Start Date10 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

CTRI/2024/10/074853

/ Not yet recruitingPhase 4IIT

Efficacy and safety of Curcuma longa either alone or in combination with metformin on glycemic status in prediabetes population: A Randomized, double-blinded, double-dummy, placebo-controlled, factorial design trial - NIL

Start Date15 Oct 2025

Sponsor / Collaborator-

NCT06999343

/ Not yet recruitingPhase 3

Exploring the Anti-ageing Effects of Metformin in COPD

Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1.
Main objective:
To compare the change in FEV1 at 3 years follow-up in patients receiving metformin versus placebo.
Participants will take metformin (850mg) or placebo twice daily for 3 years.

Start Date01 Sep 2025

Sponsor / Collaborator

Fundación Instituto de Investigación Sanitaria Aragón

100 Clinical Results associated with Metformin Hydrochloride

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100 Translational Medicine associated with Metformin Hydrochloride

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100 Patents (Medical) associated with Metformin Hydrochloride

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28,718

Literatures (Medical) associated with Metformin Hydrochloride

25 Dec 2025·Oriental Journal of Chemistry

Quantitative UV-Spectrophotometric Method for the Analysis of Teneligliptin HBr and Metformin HCl in Pharmaceutical Dosage form: Development and Validation

Author: Gahtori, Archana ; Khanduri, Praveen

This study developed a UV-spectrophotometric method for the simultaneous quantification of Metformin HCl and Teneligliptin HBr. Both active pharmaceutical ingredients were found to be soluble in 0.1N sulfuric acid, which was thus chosen as the solvent for analysis. The maximum absorption wavelengths for Metformin HCl and Teneligliptin HBr were identified at 220 nm and 240 nm, respectively. Standard stock solutions were prepared, and samples from commercially available tablets were accurately measured and dissolved for testing. Method validation included evaluations of linearity, precision (intra-day and inter-day), accuracy, robustness, as well as detection (LOD) and quantification limits (LOQ). The method exhibited strong precision and accuracy, with %RSD values less than 2%. Both LOD and LOQ demonstrated sufficient sensitivity, and the method proved effective for analyzing commercial formulations, achieving compliance levels of 99.20% for Metformin and 102.00% for Teneligliptin.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Pharmacological approaches to enhance mitochondrial biogenesis: focus on PGC-1Α, AMPK, and SIRT1 in cellular health

Review

Author: Palabiyik, Esra ; Palabiyik, Ahmet Alperen

BACKGROUND:

Mitochondrial biogenesis is essential for cellular energy balance and metabolic stability. Its dysregulation is linked to various metabolic and neurodegenerative diseases, making it a significant therapeutic target. Pharmacological approaches aimed at enhancing mitochondrial function have gained attention for their potential to restore cellular metabolism.

OBJECTIVES:

This review examines recent advancements in pharmacological strategies targeting mitochondrial biogenesis, focusing on the roles of PGC-1α, AMPK, and SIRT1, alongside novel therapeutic agents and drug delivery systems.

METHODS:

A systematic review of studies published between 2018 and 2023 was conducted using databases such as PubMed, Web of Science, and Elsevier. Keywords related to mitochondrial biogenesis and pharmacological modulation were used to identify relevant literature.

RESULTS:

Various pharmacological agents, including resveratrol, curcumin, and metformin, activate mitochondrial biogenesis through different pathways. SIRT1 activators and AMPK agonists have shown promise in improving mitochondrial function. Advances in mitochondria-targeted drug delivery systems enhance therapeutic efficacy, yet challenges remain in clinical translation due to the complexity of mitochondrial regulation.

CONCLUSION:

Pharmacological modulation of mitochondrial biogenesis holds therapeutic potential for metabolic and neurodegenerative diseases. While preclinical studies are promising, further research is needed to optimize drug efficacy, delivery methods, and personalized treatment strategies.

01 Aug 2025·BIOMATERIALS

Zn2+-driven metformin conjugated with siRNA attenuates osteoarthritis progression by inhibiting NF-κB signaling and activating autophagy

Article

Author: Huang, Chanting ; Liu, Gang ; Qin, Zainen ; Zhao, Jinmin ; Zheng, Li ; Huang, Hongjun ; Lan, Nihan ; Liu, Siyi ; Luo, Yan ; He, Haoqiang

Osteoarthritis (OA) is a type of joint disease that influences millions of individuals. Regrettably, effective treatment for OA is currently unavailable. The challenge lies in the deep location of chondrocytes within the dense cartilage matrix that hinders the delivery and efficiency of clinical OA drugs. To overcome this obstacle, the present study proposed a hybrid nanodrug by Zinc(II) metal-drug coordination-driven self-assembly as highly efficient delivery system. This nano-assembly formulations possessed the ability to deliver two types of drugs, namely metformin (Met) and therapeutic genes (p65 siRNA). Results showed that this nano-assembly not only exhibited positive charge-driven anchoring to the cartilage matrix and effective drug delivery capacity, but also synergistically inhibited NF-κB activity and activates autophagy of OA chondrocytes, thus safeguarding the cartilage. The successful achievement of this project not only contribute to the advancement of research on bio-nanomaterials for treating OA, but also establish a robust theoretical foundation for realizing promising and functional integration of nanomedicine targeting OA.

370

News (Medical) associated with Metformin Hydrochloride

21 May 2025

·pharma.economictimes.indiatimes.com

196 Drug Samples Fail CDSCO Quality Test; One Deca-Durabolin Sample Flagged as Spurious

New Delhi: Drug regulators, during their monthly quality review, have identified around 196 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” The drug alert issued by the Central Drugs Standard Control Organization ( CDSCO ) states that out of the 196 NSQ samples, 60 were identified by central drug laboratories, while the remaining 136 were flagged by state laboratories. In addition, one drug sample identified as spurious is a “ Nandrolone Decanoate Injection,” marketed as Deca-Durabolin —an anabolic steroid used for various medical conditions, including osteoporosis and anemia. According to a note from the Union Health Ministry , the spurious sample was picked from Bihar and “is manufactured by an unauthorized manufacturer using the brand name owned by another company.” In its alert, the CDSCO specified that the tested sample failed due to issues with the “Identification and Assay of Nandrolone Decanoate .” In India, “Deca-Durabolin 50 mg” is marketed by Ahmedabad-based Zydus Healthcare, following its acquisition of the brand from MSD (Merck Sharp & Dohme) in December 2016. The matter is currently under investigation, and the purported spurious drug is subject to the outcome of the inquiry. A drug is deemed spurious if it resembles another drug in a manner likely to deceive, or if it bears upon its label or container the name of another drug—among several other conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Among the 60 NSQ samples flagged by central laboratories are Nimesulide and Paracetamol tablets manufactured by Pro-Pharma Care; Cefpodoxime Proxetil tablets by Sunvij Drugs; Ciprofloxacin tablets by Cadila Pharmaceuticals; and 57 other samples. The 136 NSQ samples identified by state laboratories include Glimepiride 1 mg and Metformin HCl 500 mg tablets manufactured by Surge Pharmaceuticals; Albendazole tablets by Samkem; and Oxfendazole and Ivermectin Bolus by Argon Remedies, among 133 other samples. The identification of drug samples as NSQ is based on the failure of the sample to meet one or more specified quality parameters. The term NSQ is defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “the failure is specific to the drug products of the batch tested by the Government Laboratory and does not warrant concerns about other drug products available in the market.” The ministry added that the identification of NSQ and spurious medicines is undertaken regularly (monthly), in collaboration with state regulators, to ensure such drugs are detected and removed from the market. By Online Bureau ,

AcquisitionDrug Approval

09 May 2025

·pharma.economictimes.indiatimes.com

NPPA sets Empagliflozin combos retail prices, as domestic brands initiate generic contest

New Delhi: As domestic brands in India began introducing their generic versions of key anti-diabetic medicine empagliflozin following the expiry of its patent, the National Pharmaceutical Pricing Authority (NPPA), has fixed the retail prices of the drug combinations and different dosage strengths. Issuing a gazette notification, the Ministry of Chemicals and Fertilizers and the country’s drug price regulator announced that “based on the decision of 132nd Authority meeting dated 29.4.2025 the authority has fixed retail prices of 84 formulations under Drugs (Prices Control) Order, 2013.” The price list attached with the official notification includes around 36 variants of empagliflozin, linagliptin and metformin hydrochloride Fixed-Dose Combinations (FDC) of various brands and manufacturers. Empagliflozin, indicated for Type-2 diabetes, inhibits the release of SGLT2 protein in the kidneys which reduces glucose reabsorption in blood and helps in lowering the blood sugar level of patients. Under the notified list the combination of empagliflozin 12.5mg and metformin hydrochloride 1000mg tablet of Corona Remedies is priced at ₹19.64, while a combination including linagliptin along with these active ingredients of Lupin is priced at ₹22.32. The notified retail prices excludes the applicable Goods and Services Tax (GST) and are applicable to the respective manufacturer and marketer specified in the list. As per a market research firm Pharmarack as of April 2025 the total market of empagliflozin and its related combination is valued around ₹745 crore. Of this, plain empagliflozin and its combination with linagliptin accounts for nearly 86 per cent of the total market. In FY25 empagliflozin plain tablets reported a Moving Annual Turnover of ₹337 crore, reflecting a market share of 45 per cent while its combination version with linagliptin had a MAT value of ₹308 crore and a market share of 41 per cent. Besides this the drug's other combinations such as empagliflozin and metformin reported an annual turnover of ₹102 crore with a 14 per cent market share. The retail price fixation exercise has been undertaken in the aftermath of the expiry of empagliflozin’s patent in March this year followed by a series of generic entrants in the market. In India, the drug patent was owned by Germany-based Boehringer Ingelheim and the drug was marketed under the brand name Jardiance. After the drug went off patent, companies like Alkem and Glenmark launched their generic versions under the brand names ‘Empanorm’ and ‘Glempa’ respectively. Besides them other major generic players like Mankind and USV also joined the fray. For patients, the development gave a major price relief as the generic versions are stated to cost around 80-90 per cent less than the patented version. As per the NPPA price list the innovator's version single tablet is priced at ₹53, whereas the other brands from the license holders Torrent, Cipla and Lupin are priced between ₹46-48 per tablet. While announcing the launch, Rajeev Juneja, Vice Chairman and Managing Director, Mankind Pharma said that, “the company will market its respective brand at ₹5.49 per tablet for the 10 mg variant and ₹9.90 per tablet for the 25 mg variant. The latest monthly progress report of Indian pharma market by Pharmarack suggests that as of April close to 147 brands from 37 companies have forayed in the empagliflozin plain and combinations market, reflecting a two-fold jump from the previous month status of 86 brands and 19 Companies. Under the provisions of Drugs (Prices Control) Order, 2013, the retail price of a new drug is fixed by NPPA and the applicant manufacturer and marketer, are required to sell the new drug within the notified price. By Abhijeet Singh ,

09 May 2025

·pharma.economictimes.indiatimes.com

NPPA sets Empagliflozin combos retail prices, as domestic brands initiate generic contest

New Delhi: As domestic brands in India began introducing their generic versions of key anti-diabetic medicine empagliflozin following the expiry of its patent, the National Pharmaceutical Pricing Authority (NPPA), has fixed the retail prices of the drug combinations and different dosage strengths. Issuing a gazette notification, the Ministry of Chemicals and Fertilizers and the country’s drug price regulator announced that “based on the decision of 132nd Authority meeting dated 29.4.2025 the authority has fixed retail prices of 84 formulations under Drugs (Prices Control) Order, 2013.” The price list attached with the official notification includes around 36 variants of empagliflozin, linagliptin and metformin hydrochloride Fixed-Dose Combinations (FDC) of various brands and manufacturers. Empagliflozin, indicated for Type-2 diabetes, inhibits the release of SGLT2 protein in the kidneys which reduces glucose reabsorption in blood and helps in lowering the blood sugar level of patients. Under the notified list the combination of empagliflozin 12.5mg and metformin hydrochloride 1000mg tablet of Corona Remedies is priced at ₹19.64, while a combination including linagliptin along with these active ingredients of Lupin is priced at ₹22.32. The notified retail prices excludes the applicable Goods and Services Tax (GST) and are applicable to the respective manufacturer and marketer specified in the list. As per a market research firm Pharmarack as of April 2025 the total market of empagliflozin and its related combination is valued around ₹745 crore. Of this, plain empagliflozin and its combination with linagliptin accounts for nearly 86 per cent of the total market. In FY25 empagliflozin plain tablets reported a Moving Annual Turnover of ₹337 crore, reflecting a market share of 45 per cent while its combination version with linagliptin had a MAT value of ₹308 crore and a market share of 41 per cent. Besides this the drug's other combinations such as empagliflozin and metformin reported an annual turnover of ₹102 crore with a 14 per cent market share. The retail price fixation exercise has been undertaken in the aftermath of the expiry of empagliflozin’s patent in March this year followed by a series of generic entrants in the market. In India, the drug patent was owned by Germany-based Boehringer Ingelheim and the drug was marketed under the brand name Jardiance. After the drug went off patent, companies like Alkem and Glenmark launched their generic versions under the brand names ‘Empanorm’ and ‘Glempa’ respectively. Besides them other major generic players like Mankind and USV also joined the fray. For patients, the development gave a major price relief as the generic versions are stated to cost around 80-90 per cent less than the patented version. As per the NPPA price list the innovator's version single tablet is priced at ₹53, whereas the other brands from the license holders Torrent, Cipla and Lupin are priced between ₹46-48 per tablet. While announcing the launch, Rajeev Juneja, Vice Chairman and Managing Director, Mankind Pharma said that, “the company will market its respective brand at ₹5.49 per tablet for the 10 mg variant and ₹9.90 per tablet for the 25 mg variant. The latest monthly progress report of Indian pharma market by Pharmarack suggests that as of April close to 147 brands from 37 companies have forayed in the empagliflozin plain and combinations market, reflecting a two-fold jump from the previous month status of 86 brands and 19 Companies. Under the provisions of Drugs (Prices Control) Order, 2013, the retail price of a new drug is fixed by NPPA and the applicant manufacturer and marketer, are required to sell the new drug within the notified price. By Abhijeet Singh ,

100 Deals associated with Metformin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00944	Metformin Hydrochloride	A10BA02	DBSALT000114

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	United States	Andrx Labs LLC	27 Apr 2004
Diabetes Mellitus, Type 2	China	Ankang Zhengda Pharmaceutical Co. Ltd.	01 Jan 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Mammary Carcinoma	Phase 3	United States	City of Hope National Medical Center	16 Dec 2024
Chronic Disease	Phase 3	United States	Oklahoma Medical Research Foundation	29 Jul 2020
Acquired Immunodeficiency Syndrome	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Feb 2019
Aortic Aneurysm, Abdominal	Phase 3	Austria	Merck Serono GmbH	26 Sep 2018
Fragile X Syndrome	Phase 3	United States	University of California, Davis	30 Apr 2018
Fragile X Syndrome	Phase 3	Canada	University of California, Davis	30 Apr 2018
Metabolic Syndrome	Phase 3	United States	Rutgers State University of New Jersey	07 Aug 2017
Atypical hyperplasia	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015
Breast Cancer	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015
Breast hyperplasia	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Not Applicable	Acidosis, Lactic	-	Metformin	dsqatkwrii(pdsknmvpah) = iailgelbdd oqcgrlsbnq (gvedqklovi ) View more	-	16 May 2025
NCT01905046 (CTgov)	Phase 3	Breast hyperplasia \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma ... View more	86	metformin hydrochloride (Arm I)	oczgepqfkr: Odds Ratio (OR) = 0.97 (95% CI, 0.36 - 2.62), P-Value = 0.951	-	13 Apr 2025
				placebo+Metformin (Arm II)
NCT02980276 (2016-001644-19 \| ###DELETE \| EMERGE, CTgov)	Phase 3	Diabetes, Gestational	535	Metformin Hydrochloride (Treatment)	ndnewtqjrg = cnibdvsxzg hocprrlzrg (metmirjrrr, sxpwbqrpsc - gisxcinczc) View more	-	17 Mar 2025
				Placebo (Control)	ndnewtqjrg = kqsgwsqppk hocprrlzrg (metmirjrrr, kjzogvorbp - lniwpntoqk) View more
NCT03229057 (COMET-PCOS, CTgov)	Phase 3	Polycystic Ovary Syndrome \| Obesity	240	OCP + Placebo (OCP + Placebo)	jsowxkhfnb = ancfbtzxet ejzeswdwuz (drldrbhjyq, evlyremphd - jmhjlqdcwf) View more	-	10 Mar 2025
				Metformin + Placebo (Metformin + Placebo)	jsowxkhfnb = xepvtwsbyr ejzeswdwuz (drldrbhjyq, ukfcpxrjhm - ylowvlvjwc) View more
NCT04055012 (CTgov)	Phase 2	Low Back Pain	23	Metformin (High Dose Metformin)	ghiyywzodr(opsbyuwqpn) = cdazzjjyyp zzlfyxcmra (zrsfozyfcq, 0.98) View more	-	21 Feb 2025
				Metformin (Low Dose Metformin)	ghiyywzodr(opsbyuwqpn) = nnxqfcqghu zzlfyxcmra (zrsfozyfcq, 0.58) View more
NCT03651895 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	14	metformin (Treatment Group)	sajfkolqjb(kfnwwusmjl) = bxqichzmrc utzygthtqh (awivhddazp, pgwvohiuip - xbrixqhybr) View more	-	18 Feb 2025
				Placebo (Placebo Group)	sajfkolqjb(kfnwwusmjl) = aiqfpkfmtt utzygthtqh (awivhddazp, qaekdjluiq - lqajrduylt) View more
NCT02946996 (CTgov)	Phase 2	Prostatic Cancer \| Metastatic Prostate Carcinoma \| Adenocarcinoma of prostate	41	Metformin (Metformin Only)	fohenulorq(qyzfrrtldo) = sihpzljgwt iudqsrriot (ishqtplyag, lbgtwjxhtk - szftdeiohc) View more	-	03 Feb 2025
				OPC (OPC Only)	fohenulorq(qyzfrrtldo) = milyskmtvj iudqsrriot (ishqtplyag, maqfwffmuz - tgcbwzlndx) View more
NCT02515773 (MOBILITY, CTgov)	Phase 4	Diamond-Blackfan Anemia 1 \| Bipolar Disorder \| Obesity	1,565	healthy lifestyle intervention (LIFE)+Metformin (MET and LIFE)	wcqhnkvjgg(aoyiniqiry) = snubfcepjk juofihlgqo (tzuwvcychx, 0.29) View more	-	14 Jan 2025
				healthy lifestyle intervention (LIFE) (Healthy Lifestyle Intervention (LIFE))	wcqhnkvjgg(aoyiniqiry) = sbfqtqqvyy juofihlgqo (tzuwvcychx, 0.29) View more
NCT03746106 (CTgov)	Phase 4	Thiamine Deficiency	7	Thiamine (Thiamine Alone)	yowfpgbxdq(hzahvqlcop) = awscwbfplh kitqxhevmh (eqrhlxfifa, 9.5) View more	-	03 Jan 2025
				Thiamine+Trimethoprim (Thiamine Co-administered With Trimethoprim)	yowfpgbxdq(hzahvqlcop) = fhektcfbxe kitqxhevmh (eqrhlxfifa, 22) View more
Pubmed \| NEWS Manual	Not Applicable	Skin Neoplasms	-	Metformin	dkbbyndvbb(pebtcjdlcl) = Our results indicate a reduced risk of non-melanoma skin cancer following exposure to metformin in individuals diagnosed with both SCC and BCC. gspllzbjai (aborvlcwcd )	Positive	01 Dec 2024