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Last update 20 Sep 2025

Insulin Glargine/Lixisenatide

Last update 20 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Hormone

Synonyms

AVE0010/Lantus, iGlarLixi, Insulin glargine/Lixisenatide

+ [13]

Target

GLP-1R x INSR

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists), INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Sanofi

Active Organization

Sanofi-Aventis Canada, Inc.

Sanofi Winthrop Industrie SASanofi KK

+ [2]

Inactive Organization

Sanofi (China) Investment Co. Ltd.Sanofi-Aventis Recherche & Développement SA

Sanofi-Aventis Deutschland GmbH

License Organization

Zealand Pharma A/S

Royalty Pharma Plc

Drug Highest PhaseApproved

First Approval Date

Switzerland (16 May 2002),

Diabetes Mellitus, Type 2

RegulationPriority Review (China)

Structure/Sequence

Sequence Code 4851β

Sequence Code 31960α

Clinical Trials associated with Insulin Glargine/Lixisenatide

NCT07173712

/ Not yet recruitingPhase 4IIT

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

Start Date01 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen University

NCT06716424

/ RecruitingPhase 4

Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA

This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.

Start Date06 Jan 2025

Sponsor / Collaborator

Sanofi

NCT06671587

/ RecruitingPhase 4

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).
Study details include:
* The study duration per participant will be approximately up to 24 weeks.
* The treatment duration will be up to 20 weeks.
* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
* Health measurement/Observation: change in TIR as the primary endpoint
* Intervention name: iGlarLixi and Gla-100
* Participant gender: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: type 2 diabetes
* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.

Start Date10 Dec 2024

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Insulin Glargine/Lixisenatide

100 Translational Medicine associated with Insulin Glargine/Lixisenatide

100 Patents (Medical) associated with Insulin Glargine/Lixisenatide

188

Literatures (Medical) associated with Insulin Glargine/Lixisenatide

01 Oct 2025·DIABETES OBESITY & METABOLISM

Evaluation of efficacy of iGlarLixi versus IDegAsp using derived time‐in‐ranges in Chinese adults with Type 2 diabetes: A post hoc analysis of the Soli‐D study

Letter

Author: Liu, Yu ; Lauand, Felipe ; Liu, Juan ; Du, Qin ; Kang, Lareina ; Xu, Weiya ; Alvarez, Agustina ; Li, Yanbing ; Huang, Qiong ; Zhang, Minlu

01 Oct 2025·DIABETES OBESITY & METABOLISM

Long‐term effectiveness of iGlarLixi treatment in people with type 2 diabetes in the United States: The soli‐durability 24‐month observational study

Article

Author: Malik, Rayaz A. ; Li, Xuan ; Lauand, Felipe ; Alvarez, Agustina ; Khunti, Kamlesh ; Adaş, Mine ; Anderson, John ; Amani, Mohammed E. A. ; Russo, Giuseppina

Abstract:

Aim:

To evaluate the effectiveness and safety of a fixed‐ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) over 24 months in people with type 2 diabetes (T2D).

Methods:

In this retrospective, observational study, data were collected from the Optum Market Clarity® database in the United States. People with T2D aged ≥18 years, previously treated with oral antidiabetic drugs ± basal insulin or glucagon‐like peptide‐1 receptor agonists, who initiated iGlarLixi between 1 January 2017 and 31 March 2020 and received ≥1 iGlarLixi prescription were included. The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, achievement of HbA1c <7%, change in body weight and rate of hypoglycaemia (defined as inpatient or outpatient claims, or blood glucose <70 mg/dL) every 3 months over 24 months.

Results:

In total, 1685 people were included in this analysis (mean age, 58.4 years; 52.6% female). In the overall population, including imputed values, mean ± standard deviation (SD) baseline HbA1c (9.3 ± 1.8%) was reduced by 0.9% to 8.3 ± 1.8% at 24 months. A HbA1c target of <7% was achieved in 22.2% of people at 24 months. Mean ± SD body weight remained stable from baseline (102.1 ± 24.2 kg) to 24 months (101.9 ± 23.3 kg). The hypoglycaemia event rate was 16.1 per 100 person‐years (P100PY) at baseline and decreased to 11.4 P100PY at 24 months.

Conclusions:

iGlarLixi initiation was associated with improved glycaemic control, without body weight change or increased hypoglycaemia over 24 months.

01 Aug 2025·DIABETES OBESITY & METABOLISM

What is the ‘real‐world’ experience with fixed‐ratio combination therapy (insulin + GLP‐1 receptor agonist) in routine clinical practice? Take‐home messages for clinicians regarding key outcomes

Review

Author: Frias, Juan Pablo

Abstract:

Aims:

The fixed‐ratio combinations (FRCs) of a basal insulin and glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA), IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), offer a once‐daily injectable treatment option for adults with type 2 diabetes (T2D), combining complementary mechanisms of action to target both fasting and postprandial hyperglycaemia. While randomized controlled trials have demonstrated their efficacy and safety, real‐world evidence (RWE) provides important insights into their effectiveness, tolerability and use across routine clinical practice.

Materials and Methods:

This is a narrative review of selected real‐world studies assessing the FRCs IDegLira and iGlarLixi in adults with T2D. Studies assessing the use of FRCs to intensify and simplify therapy, as well as their use in special populations such as older adults were reviewed and are summarized.

Results:

Among individuals inadequately controlled on oral antihyperglycaemic drugs (OADs), basal insulin ± OADs, or GLP‐1 RAs, initiation of FRC therapy consistently improved glycaemic outcomes, supported modest weight loss or stability, and was associated with a low risk of hypoglycaemia. FRCs have also been evaluated as a strategy for simplifying complex insulin regimens. Transitions from basal–bolus or premixed insulin to FRCs maintained or improved glycaemic control while reducing total daily insulin dose and injection burden.Evidence in special populations and clinical contexts further supports the utility of FRCs. In older adults, FRC use was associated with reductions in HbA1c and hypoglycaemia risk, along with improvements in treatment satisfaction and functional measures. During Ramadan fasting, iGlarLixi demonstrated favourable glycaemic control, low hypoglycaemia incidence, modest weight loss and high adherence. Studies assessing glycaemic control using continuous glucose monitoring showed improvements in time in range, reductions in time above range and stable time below range, indicating enhanced glycaemic stability without increased risk of hypoglycaemia.Two real‐world head‐to‐head studies comparing IDegLira and iGlarLixi found both FRCs to be effective and well tolerated. IDegLira was associated with greater weight loss and lower insulin dose requirements, while iGlarLixi showed advantages in postprandial glucose control. Both agents demonstrated significant improvements in HbA1c and low rates of hypoglycaemia.

Conclusions:

Collectively, these real‐world studies confirm that FRCs are effective, safe and patient‐centred treatment options for adults with T2D. Their simplified dosing, metabolic benefits and favourable safety profiles support their use for both therapy intensification and de‐intensification across a broad spectrum of clinical scenarios. These findings reinforce results from randomized controlled trials, providing further confidence in the role of FRCs in contemporary diabetes care.

News (Medical) associated with Insulin Glargine/Lixisenatide

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

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

100 Deals associated with Insulin Glargine/Lixisenatide

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Switzerland	Sanofi-Aventis U.S. LLC	16 May 2002

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05413369 (SoliD, CTgov)	Phase 3	Diabetes Mellitus, Type 2	582	Insulin glargine/Lixisenatide+SGLT2 inhibitor+Metformin (iGlarLixi)	fmugbqqxuw(vhudfvixuk) = rniwhsjkhj ihrqsvsqtx (lxkwxfoesh, 0.05) View more	-	30 Oct 2024
				SGLT2 inhibitor+IDegAsp+Metformin (IDegAsp)	fmugbqqxuw(vhudfvixuk) = efsokxwadi ihrqsvsqtx (lxkwxfoesh, 0.05) View more
NCT05413369 (SoliD, ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 2	582	iGlarLixi	igdojivfgj(nvzxcftlra): Difference = -0.20 (95% CI, -0.33 to -0.07), P-Value = <0.001 View more	Non-inferior	21 Jun 2024
				IDegAsp
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi	lropfqmasj(dyrckgjeqg) = sqtmicmzzt lounsmdyoy (vvehvghtlv ) View more	-	14 Jun 2024
				BID PI dosing	lropfqmasj(dyrckgjeqg) = xzlfseypkc lounsmdyoy (vvehvghtlv )
NCT05114590 (374-P, ADA2024)	Phase 4	Diabetes Mellitus, Type 2	124	Sulfonylurea (SU) users	whhdkwxktj(buhqrzosbd) = only reported by SU users mhauppywno (mvzjrujdes ) View more	Positive	14 Jun 2024
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi	pmqadmucps(ltpnicfypj) = hkbxngijgf ucrdmxsell (qehjyikyof ) View more	-	14 Jun 2024
NCT05114590 (374-P \| 839-P \| Soli-CGM, CTgov)	Phase 4	Diabetes Mellitus, Type 2	124	Insulin glargine/Lixisenatide	pbtmmqtpqo(pbvdqmpzpr) = ywqnwrsilb wkbzaqqjjt (dhtikqnneq, lijjcywysy - dreoqqcrqt) View more	-	24 May 2024
NCT03798054 \| NCT03798080 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	iGlarLixi	mbuccasvgn(btfvmkkgtf): P-Value = 11.45	-	30 Mar 2023
				Glargine 100 U/mL
NCT03767543 (LixiLan ONE CAN, Pubmed \| Diabetes Obes Metab)	Phase 3	Diabetes Mellitus, Type 2	265	Daily titration of iGlarLixi	ujzonawnrd(ryqniytwwk) = kbfrrcklne zhicovzrph (lhnuxclgof ) View more	Positive	07 Jun 2022
				Weekly titration of iGlarLixi	ujzonawnrd(ryqniytwwk) = bxwqrpddvi zhicovzrph (lhnuxclgof ) View more
NCT03798054 (LixiLan-O-AP, Pubmed \| Diabetes Obes Metab)	Phase 3	Diabetes Mellitus, Type 2	878	iGlarLixi	zfmqqumzep(urhyqmibvm) = bwwafdnrlx urmsealzkc (ipglcncfho ) View more	Positive	19 Apr 2022
				Insulin glargine 100 U/mL	zfmqqumzep(urhyqmibvm) = wyclrdnqzw urmsealzkc (ipglcncfho )
NCT00069784 \| NCT02058147 (Pubmed \| J Diabetes Complications)	Phase 3	Diabetes Complications	-	iGlarLixi	rkirrhdzzc(bcmoxvgvga) = mmbmlvsohc lmgggmuyql (xgulxareum ) View more	Positive	25 Jan 2022
				iGlarLixi (Standard of Care)	-

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