Delving into the Latest Updates on Metformin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HENFORMIN F.C., ANJ 900, ANJ-900

+ [3]

Target

GPD1 x PRKAB1

Action

modulators, activators

Mechanism

GPD1 modulators(glycerol-3-phosphate dehydrogenase 1 modulators), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseOther Diseases+ [10]

Active Indication

Differentiated Thyroid Gland CarcinomaDepressive DisorderHIV Infections+ [19]

Inactive Indication

Diabetes Mellitus, Type 2Ischemic stroke

Originator Organization

Elcelyx Therapeutics, Inc.

Active Organization

Baylor College of Medicine

University of Minnesota

Peking Union Medical College Hospital

+ [10]

Inactive Organization

Anji Pharmaceuticals, Inc.

Elcelyx Therapeutics, Inc.

The Medical University of South Carolina

+ [2]

License Organization

Anji Pharmaceuticals (Shanghai) Co., Ltd.

Emory University

Elcelyx Therapeutics, Inc.

+ [3]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC4H11N5

InChIKeyXZWYZXLIPXDOLR-UHFFFAOYSA-N

CAS Registry657-24-9

Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.

Start Date01 Jul 2026

Sponsor / Collaborator

University of Minnesota

NCT07226453

/ Not yet recruitingPhase 2IIT

A Target Validation and Efficacy Study of Metformin in Patients With Recurrent or Progressive Posterior Fossa Group A (PFA) Ependymoma

This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.

Start Date04 May 2026

Sponsor / Collaborator

The University of California, San Francisco

ChiCTR2500115457

/ Not yet recruitingNot ApplicableIIT

A Multicenter Randomized Controlled Study on the Effects of High Dietary Fiber Meal Replacement on Blood Glucose and Metabolic Improvements in Newly Diagnosed Type 2 Diabetes Patients with Obesity

Start Date01 Jan 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

100 Clinical Results associated with Metformin

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100 Translational Medicine associated with Metformin

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100 Patents (Medical) associated with Metformin

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36,518

Literatures (Medical) associated with Metformin

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Annual pharmacy cost per patient achieving composite treatment endpoints: a cost to target analysis of tirzepatide versus subcutaneous semaglutide 1 mg in patients with type 2 diabetes in the UK

Article

Author: Kanumilli, Naresh ; Evans, Jerome ; Cattin, Juliette ; Debackere, Nele ; Osumili, Beatrice ; Buckingham, Mike ; Hunt, Barnaby ; Webb, Joanne ; Nowakowski, Piotr

INTRODUCTION:

Tirzepatide is a treatment for type 2 diabetes associated with improvements in glycemic control and weight loss, and a low risk of hypoglycemia when not used in combination with insulin or insulin secretagogues. A cost to target analysis of tirzepatide 5, 10 and 15 mg versus subcutaneous semaglutide 1 mg in the UK setting was performed, calculating the annual pharmacy cost per patient treated to six composite endpoints combining glycemic control (glycated hemoglobin [HbA1c] ≤ 6.5% [48 mmol/mol] and <7.0% [53 mmol/mol]) with weight loss (≥5%, ≥10%, ≥15%) and avoidance of hypoglycemia. The costing analysis was based on the tirzepatide costs appraised by NICE as part of TA924.

METHODS:

The proportions of patients achieving composite treatment targets with tirzepatide and semaglutide (both in combination with metformin) were taken from a post-hoc analysis of the SURPASS-2 clinical trial (N = 1,845). Costs per patient treated to target were calculated by dividing the annual treatment costs associated with each intervention by the proportion of patients achieving the treatment target with each intervention.

RESULTS:

Tirzepatide 5, 10 and 15 mg were associated with a lower pharmacy cost per patient achieving treatment target than semaglutide 1 mg for the majority of endpoints evaluated. Differences became greater at more strict treatment targets. For example, the cost per patient achieving HbA1c ≤6.5%, weight loss ≥15%, and no hypoglycemia was GBP 5,650, GBP 8,665 and GBP 9,462 lower with tirzepatide 5, 10 and 15 mg, respectively, compared with semaglutide 1 mg over a 1-year time horizon. The only endpoint where semaglutide 1 mg was associated with a lower cost per patient achieving target was HbA1c <7.0%, weight loss ≥5%, and no hypoglycemia.

CONCLUSIONS:

Compared to semaglutide, tirzepatide was associated with a lower annual pharmacy cost per patient with diabetes achieving treatment target in the UK for the majority of endpoints, with greater differences at more strict treatment targets.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Clinical benefits and cost saving of achieving composite treatment targets for type 2 diabetes – A modeling study

Article

Author: Ding, Yuchen ; Wang, Rui ; Liu, Yanjun ; Osumili, Beatrice ; Si, Si ; Li, Jinnan

OBJECTIVES:

This study assessed the long-term clinical benefits and cost savings associated with achieving composite treatment targets (CTT) of stringent glycemic control, weight reduction and no hypoglycemia in predominantly Chinese patients with Type 2 Diabetes (T2D) inadequately controlled with metformin and/or sulfonylurea.

METHODS:

The study was conducted using an implementation of the UK Prospective Diabetes Study Outcomes Model Version 2 (UKPDS OM2) in Microsoft Excel, with additional modules for treatment switching, weight change, and hypoglycemia. Thirty-year healthcare costs were projected to capture macro- and microvascular complications, hypoglycemia and diabetic treatment. Baseline and efficacy inputs were extracted from the SURPASS-AP-Combo trial (NCT04093752), a predominantly Chinese cohort. Cost inputs were derived from literature review. Patients were categorized as "Achieved" or "Failed" based on whether they met the CTT (i.e. HbA1c ≤6.5%, ≥10% weight reduction, and no hypoglycemia event [blood glucose < 3.0 mmol/L or severe hypoglycemia]) at the end of SURPASS-AP-Combo trial, regardless of treatment received. For the Achieved group, sustained CTT was assumed for 3, 5, or 10 years before natural disease progression per UKPDS OM2 progression trajectories. The Failed group followed UKPDS OM2 progression trajectories throughout. Treatment intensification to basal-bolus insulin was triggered when HbA1c levels reached predefined CTT-based thresholds. Scenario analyses applied less stringent CTT.

RESULTS:

Sustained achievement of CTT for 3, 5 and 10 years yielded 0.31, 0.40 and 0.56 quality-adjusted life years (QALYs) and cost savings of ¥22,336, ¥32,692, ¥53,234 per patient, respectively. These savings were attributable to reduced complications, hypoglycemia and delayed treatment intensification. Slightly smaller savings were observed applying less stringent CTT.

CONCLUSIONS:

In this modeling study, a sustained achievement of CTT led to improved clinical benefits and significant direct medical cost savings. The longer the achievement period and the more stringent CTT, the greater the clinical benefits and cost savings.

15 Dec 2026·SCANDINAVIAN JOURNAL OF PRIMARY HEALTH CARE

Comparing measured and reported change in gastrointestinal symptoms after initiation of metformin treatment: a questionnaire validation study

Article

Author: Rådholm, Karin ; Jansson, Stefan ; Wenemark, Marika ; Rolandsson, Olov ; Daka, Bledar ; Kalin, Kenny ; af Geijerstam, Peder

BACKGROUND:

The majority of individuals in Sweden with type 2 diabetes have their sole health care provider in primary health care. Metformin treatment often causes gastrointestinal side-effects. Our aim was to construct and validate a questionnaire assessing gastrointestinal symptoms before and after starting metformin treatment for type 2 diabetes.

METHODS:

In the Interaction Between Metformin and Microbiota (MEMO) study, 54 participants rated six gastrointestinal symptoms at baseline and after 2 months of metformin treatment in a questionnaire (measured change, i.e. the difference between assessments at these two time points), as well as direct assessment of perceived change in symptoms after 2 months in a separate validation questionnaire (reported change, i.e. how participants themselves have perceived the change between the same two time points). Spearman's ρ was calculated and reported with its 95% CI.

RESULTS:

The agreement between reported and measured change of symptoms, measured as Spearman's ρ, was above 0.4 for 4 out of 6 symptoms (poor appetite 0.60 [95% CI 0.39-0.75], loose stool or diarrhea 0.58 [95% CI 0.37-0.74], flatulence 0.45 [95% CI 0.21-0.64], and abdominal pain 0.45 [95% CI 0.20-0.65]). The agreement was lower for nausea and vomiting, although these were numerically above 75% in agreement, likely due to few symptomatic participants overall.

CONCLUSION:

For common side-effect symptoms associated with metformin treatment, our study shows that symptom change measured as the difference between assessments at two different time-points was in overall agreement, validating the usability of the constructed questionnaire for metformin side-effects.

161

News (Medical) associated with Metformin

03 Apr 2026

·www.drugs.com

Fluvoxamine Improves Fatigue, QoL in Long COVID

FRIDAY, April 3, 2026 -- For patients with postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), fluvoxamine seems effective for reducing fatigue and improving quality of life (QoL), according to a study published online March 31 in the Annals of Internal Medicine . Gilmar Reis, M.D., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues examined the efficacy of fluvoxamine and metformin for long COVID fatigue in a randomized adaptive trial. A total of 399 adults with fatigue persisting 90 or more days after confirmed SARS-CoV-2 infection were enrolled and randomly assigned to 60 days of fluvoxamine (100 mg twice daily), metformin (750 mg twice daily), or matching placebo. The researchers found that compared with placebo, there was a significant reduction in fatigue with fluvoxamine at day 60 as assessed by the Fatigue Severity Scale score (mean difference, -0.43), with a sustained effect at day 90 (mean difference, -0.58). Improvement was also seen in QoL scores with high posterior probability for fluvoxamine. No significant benefit was seen with metformin. Adverse events occurred less often with fluvoxamine versus metformin or placebo (20.0 versus 28.8 and 29.7 percent, respectively). Across all groups, grade 3 and higher adverse events were rare. "This trial gives clinicians their first strong evidence for a medication that helps reduce long COVID fatigue," corresponding author Jamie Forrest, Ph.D., from the University of British Columbia in Vancouver, Canada, said in a statement. "Patients want something they can try today – and this finding brings us closer to that reality." One author disclosed ties to the biopharmaceutical industry. Abstract/Full Text

Clinical Result

01 Apr 2026

·www.drugs.com

Antidepressant Might Help Long COVID Fatigue, Study Says

WEDNESDAY, April 1, 2026 — A common antidepressant appears to help reduce fatigue in people living with long COVID, a new study says. Fluvoxamine – a low-cost and widely available antidepressant – significantly improved fatigue among long COVID patients within two to three months, researchers reported March 31 in the Annals of Internal Medicine . “This is an important step forward for patients who have been desperate for evidence‑based options,” senior researcher Edward Mills , a professor at McMaster University in Ontario, Canada, said in a news release. “Fluvoxamine showed consistent and meaningful benefits, and because it's already widely used and well understood, it has clear potential for clinical use,” he said. Fatigue is the most common and debilitating symptom of long COVID , researchers said in background notes. For the new study, they recruited nearly 400 adults in Brazil who continued to experience fatigue for at least three months after they’d become infected with COVID. Participants were randomly asked to take fluvoxamine (Luvox); the diabetes medication metformin ; or a placebo for 60 days. “We wanted to test whether two existing, widely available and affordable medications could help,” Mills said. “Both had biological reasons to think they might work against long COVID fatigue, but neither had been rigorously tested for this purpose in a proper clinical trial.” Fluvoxamine reduced fatigue more than a placebo, with researchers finding a 99% probability that it outperformed the placebo. However, metformin did not offer any meaningful benefit against long COVID-related fatigue, even though it’s been shown to reduce the risk of long COVID when taken during infection, researchers said. “This trial gives clinicians their first strong evidence for a medication that helps reduce long COVID fatigue. Patients want something they can try today – and this finding brings us closer to that reality,” investigator Jamie Forrest , a postdoctoral research fellow at the University of British Columbia, said in a news release. Despite these findings, researchers said more study is needed to understand who would benefit most from fluvoxamine and how the drug works to ease fatigue among long COVID patients. Sources McMaster University, news release, March 30, 2026

01 Apr 2026

·www.drugs.com

Antidepressant, Fluvoxamine, Might Help Long COVID Fatigue, Study Says

WEDNESDAY, April 1, 2026 — A common antidepressant appears to help reduce fatigue in people living with long COVID, a new study says. Fluvoxamine – a low-cost and widely available antidepressant – significantly improved fatigue among long COVID patients within two to three months, researchers reported March 31 in the Annals of Internal Medicine . “This is an important step forward for patients who have been desperate for evidence‑based options,” senior researcher Edward Mills , a professor at McMaster University in Ontario, Canada, said in a news release. “Fluvoxamine showed consistent and meaningful benefits, and because it's already widely used and well understood, it has clear potential for clinical use,” he said. Fatigue is the most common and debilitating symptom of long COVID , researchers said in background notes. For the new study, they recruited nearly 400 adults in Brazil who continued to experience fatigue for at least three months after they’d become infected with COVID. Participants were randomly asked to take fluvoxamine ( Luvox ); the diabetes medication metformin ; or a placebo for 60 days. “We wanted to test whether two existing, widely available and affordable medications could help,” Mills said. “Both had biological reasons to think they might work against long COVID fatigue, but neither had been rigorously tested for this purpose in a proper clinical trial.” Fluvoxamine reduced fatigue more than a placebo, with researchers finding a 99% probability that it outperformed the placebo. However, metformin did not offer any meaningful benefit against long COVID-related fatigue, even though it’s been shown to reduce the risk of long COVID when taken during infection, researchers said. “This trial gives clinicians their first strong evidence for a medication that helps reduce long COVID fatigue. Patients want something they can try today – and this finding brings us closer to that reality,” investigator Jamie Forrest , a postdoctoral research fellow at the University of British Columbia, said in a news release. Despite these findings, researchers said more study is needed to understand who would benefit most from fluvoxamine and how the drug works to ease fatigue among long COVID patients. Sources McMaster University, news release, March 30, 2026

100 Deals associated with Metformin

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Metformin	A10BA02	DB00331

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Differentiated Thyroid Gland Carcinoma	Phase 3	Poland	Medical Research Agency	01 Nov 2022
Ischemic stroke	Phase 3	United States	The Medical University of South Carolina	01 Oct 2008
Diabetes Mellitus, Type 2	Phase 3	United States	National Institute of Diabetes & Digestive & Kidney Diseases	01 May 2004
Depressive Disorder	Phase 2	-	University of Minnesota	01 Jul 2026
HIV Infections	Phase 2	-	University of Minnesota	01 Jul 2026
Ependymoma	Phase 2	United States	The University of California, San Francisco	04 May 2026
Monoclonal Gammopathy of Undetermined Significance	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
Plasma Cell Leukemia	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
Smoldering Multiple Myeloma	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
COVID-19	Clinical	United States	University of Minnesota	18 Aug 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04850846 (CTgov)	Phase 2	Smoldering Multiple Myeloma \| Monoclonal Gammopathy of Undetermined Significance \| Multiple Myeloma ... View more	60	Metformin XR (Metformin)	sklfqceixt(icxsinzufq) = obazepmvfd hwgffpvvzh (vjhfpzcaiv, hfyrvnyvsa - pdsomufdkj) View more	-	09 Feb 2026
				Placebo (Placebo)	sklfqceixt(icxsinzufq) = lrtnmstobq hwgffpvvzh (vjhfpzcaiv, ygxkprvsft - hlpdjtqxpj) View more
NCT03076281 (CTgov)	Phase 2	Lymphoid Interstitial Pneumonia \| Squamous Cell Carcinoma of Head and Neck \| Laryngeal Diseases	7	Metformin Hydrochloride (Arm A (Metformin Hydrochloride))	vloegbymtv(tgvljdxeba) = yqxfycjeuh twhlribrug (jwjaravixd, jqusktbkhw - jwbxsdeqeq) View more	-	29 Jan 2026
				Doxycycline (Arm B (Doxycycline))	vloegbymtv(tgvljdxeba) = pzyahfmvhc twhlribrug (jwjaravixd, faslywtmag - qfdatkpolk) View more
NCT02946996 (CTgov)	Phase 2	Prostatic Cancer \| Metastatic Prostate Carcinoma \| Adenocarcinoma of prostate	41	Metformin (Metformin Only)	zxqizqgezf(zjyvkabgey) = vnpecqjxgi ejvlsfxddc (hxjjafzlek, vmfliwunxp - tfywbrdtjo) View more	-	03 Feb 2025
				OPC (OPC Only)	zxqizqgezf(zjyvkabgey) = oqceqyzima ejvlsfxddc (hxjjafzlek, eaisatzpie - piclymqpta) View more
Corporate Publications Manual	Phase 3	Diabetes Mellitus, Type 2	-	恒格列净+二甲双胍 (恒格列净5 mg联合组)	wwvvkmlbtj(yipsurebfu) = sdmpoluqsc qighyirfqf (znnmpbqshc ) View more	Positive	08 Jan 2024
				恒格列净+二甲双胍 (恒格列净10 mg联合组)	wwvvkmlbtj(yipsurebfu) = ygelhsnwwh qighyirfqf (znnmpbqshc ) View more
NCT04899349 (EPIK-B4, CTgov)	Phase 2	Advanced breast cancer	2	Fulvestrant+Alpelisib+Dapagliflozin+Metformin XR+Dapagliflozin + metformin XR (Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR)	tgqrgvtzae = nxiwzoaeol oppdfmoapo (qfwbwtouuh, xfxeburztp - xkvhoqglja) View more	-	12 Dec 2023
				Fulvestrant+Alpelisib+Metformin XR (Alpelisib + Fulvestrant + Metformin XR)	ynjqnvrbzy = pbzeatvbwx ouymuespnk (tpxwposwwy, rqnezdozyc - bbfaesimfc) View more
FDA Manual	Not Applicable	Diabetes Mellitus, Type 2	1,091	Placebo	acgnzhinyz(hbbiullwje) = nodreyaumt mnpndslzfc (fiorrfppjp ) View more	Positive	03 Nov 2023
				Sitagliptin 100 mg	acgnzhinyz(hbbiullwje) = lxpiykften mnpndslzfc (fiorrfppjp ) View more
JPRN-UMIN000028405 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Solid tumor	41	Metformin+nivolumab	dtxcdvrwdu(zvzhrpeaba) = avrjcengaq bzufaraarn (szpgvcadym ) View more	Positive	23 Oct 2023
NCT01968317 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia \| uterus adenocarcinoma	150	Megestrol acetat+metformin (Megestrol Acetate and Metformin)	rzshhcaqoo = krvxgvjmjg wvtpsxoenn (ntcueqtibt, hdptyvqxbf - qjkjrguyml) View more	-	13 Sep 2021
				megestrol acetate (Megestrol Acetate)	rzshhcaqoo = nmmwcziqcl wvtpsxoenn (ntcueqtibt, cafopprqsv - urqrgtsvvp) View more
CTRI/2018/07/014865 (P-24, ESMO_GI2021)	Phase 1	Advanced Hepatocellular Carcinoma	40	Sorafenib 800mg	jwqrqnbprp(xwlnektwwd) = xbnmemiiib yuwhqhscor (yqenjjtizd ) View more	Positive	03 Jul 2021
				Sorafenib 600mg	ovyfralykj(uaisfnfmqw) = ozwurbpcoi asgtwxfwng (yqmnvtlcdk, 1 - 11)
NCT02496741 (Pubmed \| Cancers (Basel)) Manual	Phase 1/2	IDH1 positive Solid Tumors IDH1 Mutation	12	Metformin+Chloroquine	rphavusbay(lvilqdkrsv) = utvavunsmd vfweiytnwj (mdrubxiuqi ) View more	Negative	19 May 2021