Delving into the Latest Updates on Insulin glargine (Sanofi) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Insulin Glargine (Genetical Recombination), INSULIN GLARGINE RECOMBINANT, GLA-100

+ [14]

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Inactive Indication

Acute myocardial infarctionDiabetes Mellitus, Noninsulin-Dependent, 2Diabetic Coma+ [5]

Originator Organization

Sanofi

Active Organization

Sanofi-Aventis Deutschland GmbHSanofi US Services, Inc.

Sanofi

+ [2]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (20 Apr 2000),

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Regulation-

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Structure/Sequence

Sequence Code 4851

Source: *****

Sequence Code 31960

Source: *****

To estimate the relative treatment effect of iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide) versus premixed insulin IDegAsp (insulin degludec plus insulin aspart) in people with type 2 diabetes (T2D) who advanced from basal insulin to iGlarLixi or IDegAsp in non‐Asian studies.

Materials and Methods:

Randomized controlled trials (RCTs) were identified in a systematic review by searching Embase (including congress abstracts from 2021 to 2023), MEDLINE® and CENTRAL on 10 October 2023. Treatment outcomes from non‐Asian RCTs for people with T2D previously treated with basal insulin, who switched to iGlarLixi or IDegAsp, were compared using a network meta‐analysis (NMA). Data analysis was performed using R, version 4.0.2.

Results:

The NMA included four RCTs (N = 2535). The results of the NMA showed that iGlarLixi (n = 810) was associated with a significantly greater reduction in HbA1c versus IDegAsp (n = 454) (mean difference [MD]: −0.39 [95% credible interval, CrI: −0.58, −0.21] %‐units). iGlarLixi was also associated with a significantly greater likelihood of achieving an HbA1c of <7.0% (risk ratio: 1.42, 95% CrI: 1.18, 1.71). A greater reduction in postprandial glucose was observed with iGlarLixi versus IDegAsp (MD: −1.38 [95% CrI: −2.15, −0.63] mmol/L). A body weight benefit that favoured iGlarLixi versus IDegAsp was documented (MD: −1.54 [95% CrI: −2.26, −0.84] kg). Hypoglycaemia evaluation was inconclusive due to definitional differences between trials.

Conclusions:

Once‐daily iGlarLixi was associated with superior blood glucose control and body weight benefit compared with IDegAsp in insulin‐experienced populations with T2D in non‐Asian RCTs.

01 Jun 2025·DIABETES OBESITY & METABOLISM

Time spent in glycaemic control with sustained body weight reduction with tirzepatide: A post hoc analysis of the SURPASS clinical trial programme

Article

Author: Thieu, Vivian T. ; Batterham, Rachel L. ; Liu, Minzhi ; Rosenstock, Julio ; Chen, Yanyun ; Bergman, Brandon K. ; Karanikas, Chrisanthi A. ; Garvey, W. Timothy ; Sharma, Palash

Abstract:

Aims:

This participant‐level exploratory analysis assessed the continuous time spent in glycaemic control and/or with sustained weight reductions with tirzepatide treatment in participants with type 2 diabetes (T2D) from the SURPASS programme.

Materials and Methods:

Participants (N = 6246) from SURPASS 1–5 were randomized to once weekly tirzepatide (5, 10 or 15 mg) or comparator (once weekly placebo, once weekly semaglutide 1 mg, insulin degludec or insulin glargine). Continuous time spent with HbA1c < 7.0% (53 mmol/mol), ≤6.5% (48 mmol/mol) and ≥5% body weight reduction and combined HbA1c ≤ 6.5% (48 mmol/mol) with a ≥5% body weight reduction were assessed through 40 weeks (SURPASS‐1, ‐2, and ‐5) or 52 weeks (SURPASS‐3 and ‐4). The non‐parametric Wilcoxon rank sum test was used to compare the median duration of continuous time spent in control, and logistic regression was used to analyse the proportion of participants achieving glycaemic control and body weight reduction at any time points or at the end of the primary study period.

Results:

Median time spent with HbA1c < 7.0% (53 mmol/mol) was 80% (tirzepatide) versus 70% (semaglutide) and 0% (placebo) of the treatment duration in 40‐week studies, and 77%–85% (tirzepatide) versus 62% (insulin degludec) and 23% (insulin glargine) of the treatment duration in 52‐week studies (p < 0.001). Time spent with HbA1c < 7.0% (53 mmol/mol) was generally similar across all tirzepatide doses in each study. Dose‐dependent increases in time spent with ≥5% body weight reduction were observed with tirzepatide (median time spent: 20%–77% with tirzepatide versus 25% with semaglutide 1 mg) (p < 0.001). Tirzepatide‐treated participants experienced longer time spent with HbA1c ≤ 6.5% (48 mmol/mol) and ≥5% body weight reduction versus semaglutide (median: 35%–60% vs. 7%) (p < 0.001).

Conclusions:

In this post hoc analysis, people with T2D experienced substantially longer continuous time in glycaemic control and more sustained body weight reductions with tirzepatide versus placebo and active comparators.

01 Jun 2025·DIABETES OBESITY & METABOLISM

An open‐label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability

Article

Author: Plum‐Moerschel, Leona ; Samsonraj, R. ; Loganathan, Subramanian ; Panda, Jayanti ; Murugesan, Sundara Moorthi Nainar ; Lou, Olivia ; Latres, Esther ; Gopu, C. L. ; Athalye, Sandeep Nilkanth ; Marwah, Ashwani

Abstract:

Aim:

This trial evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of oral insulin Tregopil (Part 1; results discussed in this paper) and the post‐prandial glucose control with different meal types in comparison with insulin aspart (Part 2) in patients with type 1 diabetes mellitus (T1DM).

Materials and Methods:

This Phase 1, open‐label, multiple ascending dose (30/45/60 mg/60 + 30 mg rescue insulin Tregopil) trial enrolled 37 patients with T1DM (3 female [8.1%], 34 male [91.9%]; median age: 39.5 years). Following screening, patients entered a run‐in phase to optimize their basal‐bolus (insulin glargine and insulin aspart) insulin therapy, and insulin Tregopil was administered orally 10 min before the three major meals of the day in all cohorts during this period. Safety assessments included adverse events and hypo−/hyperglycaemic episodes, vital signs, electrocardiograms, laboratory safety parameters and physical examination. PK and PD were the secondary objectives.

Results:

The overall safety profile of insulin Tregopil indicated no safety concerns except a PD effect (hypoglycaemia). The incidence of hypoglycaemia did not increase with increasing doses of insulin Tregopil, and none of the episodes were severe. In general, the variability of the PK/PD parameters was high. Insulin Tregopil demonstrated a rapid onset of action, with peak blood concentrations reached within 15–20 min post‐dosing. Subsequently, insulin Tregopil exerted a PD effect for up to 105 min.

Conclusion:

Fixed‐dose insulin Tregopil reduced the requirement for insulin aspart supplementation, although it was not a viable stand‐alone option for the daily management of T1DM. Insulin Tregopil could be explored with a flexible dosing approach and be titrated based on individual needs.

Trial Registration:

The trial is registered at Clinicaltrials.gov (CT.gov identifier: NCT04141423). The ethical approval number for the protocol is 2019146.

151

News (Medical) associated with Insulin glargine (Sanofi)

24 Apr 2025

·endpts.com

Only two-thirds of FDA-approved biosimilars have launched, report finds

As President Donald Trump has sought to speed the development and approval of new biosimilar competition to expensive biologics, only 66% of FDA-approved biosimilars have actually been commercialized, more than a decade since the agency began approving them, a new Samsung Bioepis quarterly report found. The launch tally includes 10 new FDA biosimilar approvals in the first quarter of 2025 and five new launches, for 48 commercializations out of 73 approvals. Even still, blockbusters like AbbVie’s Humira and Amgen’s Enbrel have continued to thwart any major competition, as biosimilars to their cash cows first won FDA approval starting in 2016. In the case of Humira, the Samsung report explains how there are now 10 biosimilars priced at greater than 80% off the brand name, and seven at 85-87% off. And yet AbbVie still controls 77% of the overall adalimumab market. Similarly, four insulin glargine biosimilars have launched over the last five years to compete with Sanofi’s Lantus, first approved by FDA in 2000. That biosimilar competition has only captured 6% of the total market. On the flip side, biosimilar cancer treatments priced closer to their brand name counterparts are clearly capturing volume. Avastin, Herceptin and Rituxan biosimilars control more than three-quarters of their brand-name biologics’ markets. As far as reforms, the report notes that it typically costs between $100 million and $300 million and 7-8 years to develop a new biosimilar, but analyses from BCG suggest streamlining proposals could reduce development costs by $50 million to $225 million and timelines by 1-2 years.

Drug ApprovalBiosimilar

15 Apr 2025

·pharma.economictimes.indiatimes.com

Sweet Surrender: Sanofi puts star insulin brand Lantus up for sale, eyes Rs 2,000 crore from Indian pharma giants

Mumbai: Sanofi India has started the process of selling its flagship insulin brand, Lantus, with major domestic pharmaceutical companies such as Glenmark , Dr. Reddy's Laboratories , and Emcure Pharma reportedly in talks to acquire it, people familiar with the matter told ET. The French pharmaceutical giant has set a minimum price of ₹2,000 crore, a sharp reduction from its initial asking price of about ₹3,000 crore, they said. A spokesperson for Sanofi India said: "We do not comment on speculation." Dr. Reddy's, Glenmark and Emcure did not respond to queries. The deal, if it goes through, would catapult Lantus to India's most valuable pharma brand. The people cited above, however, said if there is insufficient bidder interest, Sanofi might instead pursue a licensing agreement with drug makers, similar to what it has done in the past. Prescribed extensively to diabetes patients, Lantus has built a strong reputation, making it the market leader for about two decades. Newer Insulin Options a Threat While it remains a key revenue contributor for Sanofi in India, Lantus' sales have been sliding in recent years. Additionally, a 21% price reduction mandated by the government in 2023 has squeezed margins. Also, insulins are getting better every year, and some - like a once-a-week drug - may further erode Lantus' market share. However, Lantus continues to far outsell many of its rival brands. India's pharmaceutical market is expanding rapidly, driven by over 100 million diabetes patients, making strong brands highly sought-after among drugmakers. For Sanofi, the decision to sell Lantus could be part of a broader strategy to focus on bringing its patented drugs to India, and growing Opella-its consumer healthcare business. Sanofi has of late been making brisk moves in India. Last year, it launched Soliqua, a mix of insulin glargine and lixisenatide, a drug that mimics the GLP-1 hormone to help control sugar and lose weight. The pharma giant also forged partnerships with several firms, including Emcure for the distribution of its cardiovascular drugs, Dr. Reddy's for vaccines, and Cipla for neurology products. Lantus clocked sales of ₹426 crore on a moving annual turnover (MAT) basis for the 12 months through February 2025, according to industry tracker and market researcher PharmaTrac. This marks a decline from ₹588 crore in the same period in 2022. Sales would have been much higher if institutional sales and government supplies were also included, a person said. Danish drugmaker Novo Nordisk leads the domestic market for insulins, with as many as six out of the top ten brands sold in India. The Indian market for insulins-split into a spectrum of brands-is just over ₹4,500 crore, and is growing at 6% annually. Part of a category known as insulin glargine, Lantus has a unique positioning due to its long-acting effect which only requires one shot daily. This gives it an edge over other old insulin types that are needed before meals or twice during the day, making it a sought-after brand. The second-most sold brand of insulin glargine in India is Toujeo, also from the Sanofi stable but with a higher concentration of the dose. Toujeo recorded sales of ₹140 crore this February on a MAT basis. Among Indian drugs, Lantus' rival is Basalog, a brand Eris Pharma acquired last year as part of a broader deal with Biocon Biologics. By Vikas Dandekar ,

AcquisitionLicense out/inDrug Approval

10 Apr 2025

·pipelinereview.com

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

Drug ApprovalImmunotherapy

100 Deals associated with Insulin glargine (Sanofi)

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External Link

KEGG	Wiki	ATC	Drug Bank
D03250	Insulin glargine (Sanofi)	A10AE04	DB00047

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Iceland	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Liechtenstein	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Norway	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus, Type 1	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000
Diabetes Mellitus, Type 2	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	United States	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Argentina	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Brazil	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Canada	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Mexico	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	United States	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Argentina	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Brazil	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Canada	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Mexico	Sanofi	01 Apr 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04980027 (SAFEGUARD Study, Pubmed \| Diabetes Ther)	Phase 4	-	220	Insulin Glargine 300 U/ml	axvlklaijf(jiifhcedee) = vqvgmpcdfd zejsrzlaxo (qgawglnuwe ) View more	Positive	08 May 2025
NEWS Manual	Not Applicable	Diabetes Mellitus, Type 2	568	甘精胰岛素U300 (初治)	dzbohtyqry(ylwkkjazos) = tdzwzxxrns iepeowvvve (edwxcomvoc ) View more	Positive	19 Nov 2024
				甘精胰岛素U300 (基础胰岛素转换)	dzbohtyqry(ylwkkjazos) = tbkbxwqziv iepeowvvve (edwxcomvoc ) View more
NCT03406000 (TOP1, Pubmed)	Phase 4	Diabetes Mellitus, Type 1	-	Twice-daily basal insulin	oushugmvkf(kdydapadeh) = qzfoambjuh mgrchmowwl (noejzzsgwx ) View more	Positive	09 Jul 2024
ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	bldscxkpzl(zjxquveqno) = chueottsly mdpenpregd (zscnhlvzcs, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	bldscxkpzl(zjxquveqno) = wtrntdsgfu mdpenpregd (zscnhlvzcs, ±60.6)
NCT03703869 (Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2	412	Insulin Glargine U300 (Gla-300)	hczqmoqugg(rdnuqfnqnx) = PROs improved mvsqzlqpbj (vcznohnsso ) View more	Positive	01 Mar 2024
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Metformin+Exenatide	elcprgopat(ozjnvvyjzw) = uxnwtvqpqj wfqsiigqhx (hngvbpfvwi, 7.89) View more	-	29 Dec 2023
EASD2023	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine 300 U/mL (Gla-300)	pjphjvpodt(wedzazrqba) = suztvqebnp lxbjjkrjcy (eevjodfbac )	-	05 Oct 2023
				Long-acting basal insulins (BIs)/NPH insulin	pjphjvpodt(wedzazrqba) = eghnwnaqmb lxbjjkrjcy (eevjodfbac )
THU388 (ENDO2023)	Not Applicable	Edema Anti-IA2 antibodies	-	Insulin Glargine	dhafjmcqbd(rcxadynrfl) = Patient developed extensive 2+ pitting edema in bilateral feet extending up to his calves after initiating insulin glargine, which resolved within 3 days of switching to insulin degludec yciigccfex (bjyxzkwkcj )	-	05 Oct 2023
NCT00069784 (ORIGIN, ESC2023)	Phase 3	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	layulkdswb(wxhworgton) = vgmmyhzzmu kvhrhurduy (cmmythwyaz )	-	26 Aug 2023
				Glargine	layulkdswb(wxhworgton) = kxntuljvku kvhrhurduy (cmmythwyaz )
NCT03874715 (GEMELLI X, CTgov)	Phase 3	Diabetes Mellitus, Type 1	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	arbxrqqvvu(fepvpqptjm) = lkuvaqvfbv lympjmjlfp (trhqczryzd, 18300) View more	-	21 Jul 2023
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	arbxrqqvvu(fepvpqptjm) = mvlgtsuisx lympjmjlfp (trhqczryzd, 6530) View more

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