Insulin glargine
Highest phase reached
Approved
Drug type
Protein
First approval year
2000
- First approval year
- 2000
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Insulin glargine
- abasaglar
- Abasaglar
- Abasaglar (previously abasria)
- abasaglar kwikpen
- Abasaglar kwikpen
- abasaglar previously abasria
- basaglar
- Basaglar
- ins lantus
- Ins lantus
- ins lantus opticlik
- Ins lantus opticlik
- ins lantus optiset
- Ins lantus optiset
- ins lantus solostar
- Ins lantus solostar
- insulin glargine component of basaglar
- Insulin glargine component of basaglar
- insulin glargine component of soliqua 100 33
- Insulin glargine component of soliqua 100/33
- lantus
- Lantus
- lusduna
- Lusduna
- semglee
And 7 more, listed on the interactive page.
- albiglutide insulin glargine
- basaglar component insulin glargine
- BASAGLAR COMPONENT INSULIN GLARGINE
- basalin
- Basalin
- basalog
- Basalog
- galactus
- Galactus
- Gla-100 (insulin glargine)
- glargin
- Glargin
- glargine
- Glargine
- glaricon
- Glaricon
- hoe 71gt
- HOE 71GT
- hoe 901
- HOE 901
- HOE-71GT
- HOE-901
- hoe901
- HOE901
- INSULIN (A20A-GLYCINE,B30A-ARGININE,B30B-ARGININE) (HUMAN)
And 123 more, listed on the interactive page.
- ATC classification codes
- A10AE04
Sources for recorded values
- CAS registry numbers
- 160337-95-1
- ChEMBL ID
- CHEMBL1201497
- PubChem compound IDs
- 118984454
- FDA ingredient codes (UNII)
- 2ZM8CX04RZ
- 274783
- 2589006
- Applicant
- SANOFI AVENTIS US
- Approval date
- 20 Apr 2000
- Application number
- BLA021081
- Status
- Authorised
- Status date
- 9 Jun 2000
- Authorisation date
- 9 Jun 2000
- Approved indications
- Treatment of diabetes mellitus in adults, adolescents and children aged two years and above
- Product number
- EMEA/H/C/000284
- Authorisation holder
- sanofi-aventis Deutschland GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 3
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Mellitus
European medicines record
- Patents
- 0
- Designations
- 0
- Earliest recorded loss of exclusivity
- 15 Nov 2022
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- insulin glargine
- Type
- Peptide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Protein identifier
- P06213
Open Targets mechanisms
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Hypertension
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Leukemia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Diabetic Retinopathy
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003770
- Subject identifier
- D003930
- Condition
- Atherosclerosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
- Condition
- Prediabetic State
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001121
- Subject identifier
- D011236
- Condition
- Hyperglycemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003074
- Subject identifier
- D006943
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition
- Cystic Fibrosis
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0009061
- Subject identifier
- D003550
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001068
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003770
- Condition identifier
- EFO_0003884
- Condition identifier
- EFO_0008583
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008585
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001121
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001923
- Highest recorded phase
- 3
- Condition identifier
- HP_0001297
- Condition identifier
- HP_0001943
- Highest recorded phase
- 3
- Condition identifier
- HP_0003074
- Highest recorded phase
- 3
- Condition identifier
- HP_0040270
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000873
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004995
- Condition identifier
- MONDO_0005015
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005068
- Condition identifier
- MONDO_0005136
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005147
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005148
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005154
And 10 more, listed on the interactive page.
- Event
- blood glucose abnormal
- Reports
- 262
- Reporting signal score
- 539.886
- Event
- blood glucose decreased
- Reports
- 792
- Reporting signal score
- 1,954.08
- Event
- blood glucose fluctuation
- Reports
- 230
- Reporting signal score
- 561.897
- Event
- blood glucose increased
- Reports
- 2,482
- Reporting signal score
- 5,624.23
- Event
- device operational issue
- Reports
- 244
- Reporting signal score
- 999.568
- Event
- diabetes mellitus inadequate control
- Reports
- 622
- Reporting signal score
- 1,513.27
- Event
- diabetic ketoacidosis
- Reports
- 686
- Reporting signal score
- 1,213.52
- Event
- diabetic metabolic decompensation
- Reports
- 123
- Reporting signal score
- 358.485
- Event
- diabetic retinopathy
- Reports
- 129
- Reporting signal score
- 330.594
- Event
- gait inability
- Reports
- 146
- Reporting signal score
- 205.178
- Event
- glycosylated haemoglobin increased
- Reports
- 500
- Reporting signal score
- 1,083.26
- Event
- hyperglycaemia
- Reports
- 751
- Reporting signal score
- 1,284.13
- Event
- hypoglycaemia
- Reports
- 3,628
- Reporting signal score
- 10,568.7
- Event
- hypoglycaemia neonatal
- Reports
- 111
- Reporting signal score
- 280.581
- Event
- hypoglycaemic coma
- Reports
- 339
- Reporting signal score
- 1,041.42
- Event
- hypoglycaemic unconsciousness
- Reports
- 151
- Reporting signal score
- 499.832
- Event
- ketoacidosis
- Reports
- 159
- Reporting signal score
- 275.816
- Event
- premature baby
- Reports
- 390
- Reporting signal score
- 423.127
- Event
- wrong drug administered
- Reports
- 126
- Reporting signal score
- 214.559
- Event
- wrong technique in device usage process
- Reports
- 109
- Reporting signal score
- 219.446
- NCT00000620
- NCT00069784
- NCT00082381
- NCT00097084
- NCT00097500
- NCT00097877
- NCT00099619
- NCT00106366
- NCT00110370
- NCT00135057
- NCT00135096
- NCT00147745
- NCT00151697
- NCT00174642
- NCT00174668
- NCT00174681
- NCT00174824
- NCT00184613
- NCT00184626
- NCT00191178
- NCT00191464
- NCT00258804
- NCT00268645
- NCT00272064
- NCT00272077
And 318 more, listed on the interactive page.
- Dose
- 0.2 units/kg or up to 10 units
- Route
- Subcutaneous
- How often
- Once daily
- Administer into abdomen, thigh, or deltoid
- Do not dilute or mix with other insulin or solutions
- Do not inject into lipodystrophy or lipodystrophy sites
- Rotate injection sites within the same region
- Use with caution in patients with visual impairment
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- FVNQHLCGSHLVEALYLVCGERGFFYTPKTRR
- Component
- Sequence
- Type
- Protein
- Sequence
- GIVEQCCTSICSLYQLENYCG
- 0002-7715
- 0002-8980
- 0024-5761
- 0024-5869
- 0024-5871
- 0088-2219
- 0088-2220
- 0955-2900
- 0955-3900
- 72572-422
- 72572-424
- 83257-011
- 83257-012
- 83257-014
- 83257-015
- 87682-090
- 50090-0876
- 50090-1398
- 50090-2193
- 50090-4068
- 50090-4177
- 50090-6439
- Hypolipidemic Agents
- Hypoglycemic Agents
Related records
Trials (1,136)
- 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes
- 20 Week Bridging Study in Type II DM
- 24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
- 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
- 32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
- 5 Versus 10 Units of Insulin in Hyperkalemia Management
- 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin
- A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
- A 2-Month Safety Follow-Up Trial
- A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
- A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine
- A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
- A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
- A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
- A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
- A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
- A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
Approved for (3)
- Diabetes mellitus
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
In development for (11)
- Acute myocardial infarction Phase 3
- Atherosclerosis Phase 3
- Coronary artery disorder Phase 3
- Cystic fibrosis Phase 3
- Diabetic retinopathy Early phase 1
- Hyperglycemia Phase 3
- Hypertensive disorder Phase 3
- Leukemia Phase 3
- Lymphoma Phase 3
- Malaria Phase 3
- Prediabetes syndrome Phase 3
Other linked conditions (1)
Targets (1)
- INSR Insulin receptor agonist