Insulin human
Highest phase reached
Approved
Drug type
Protein
First approval year
1982
- First approval year
- 1982
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Insulin human
- actrapid
- Actrapid
- afrezza
- Afrezza
- exubera
- Exubera
- humulin br
- Humulin br
- humulin r
- Humulin r
- inpremzia
- Inpremzia
- ins humulin r
- Ins humulin r
- insuman
- Insuman
- insuman infusat
- Insuman infusat
- myxredlin
- Myxredlin
- velosulin
- Velosulin
- abatacept ctla4 ig and nasal insulin humulin r
- Actrapid
- Actrapid (human insulin)
- Actrapid Human Insulin
- Afrezza
- Afrezza (insulin human) Inhalation Powder
- biosulin r
- Biosulin r
- capsulin
- Capsulin
- Exubera
- Exubera (inhaled insulin human)
- Exubera (inhaled insulin)
- exubera inhaled insulin human
- Exubera® (inhaled insulin)
- high molecular weight insulin human
- High molecular weight insulin human
- HIGH MOLECULAR WEIGHT INSULIN HUMAN [USP-RS]
- high molecular weight insulin human usp rs
- human insulin
- Human insulin
- Human Insulin
- HUMAN INSULIN (BIOSYNTHETIC)
- humulin
- Humulin
And 108 more, listed on the interactive page.
- CAS registry numbers
- 11061-68-0
- ChEMBL ID
- CHEMBL1201631
- PubChem compound IDs
- 118984375
- RxNorm IDs (RxCUI)
- 253182
- FDA ingredient codes (UNII)
- 1Y17CTI5SR
- A10AB01
- A10AC01
- A10AD01
- A10AE01
- A10AF01
Sources for recorded values
- Applicant
- LILLY
- Approval date
- 28 Oct 1982
- Application number
- BLA018780
- Status
- Authorised
- Status date
- 21 Feb 1997
- Authorisation date
- 21 Feb 1997
- Approved indications
- Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
- Product number
- EMEA/H/C/000201
- Authorisation holder
- Sanofi-aventis Deutschland GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- 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
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Over the counter
- Boxed warning
- Yes
- Pharmacology name
- insulin
- Type
- Peptide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- topical
- Action
- Agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Gene symbol
- INSR
- Protein identifier
- P06213
- Primary target
- Yes
- 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
- Heart Failure
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Hypertension
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Wounds and Injuries
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Stroke
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Obesity
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Stress Disorders, Post-Traumatic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001358
- Subject identifier
- D013313
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Insulin Resistance
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002614
- Subject identifier
- D007333
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003095
- Subject identifier
- D065626
- Condition
- Tobacco Use Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003768
- Subject identifier
- D014029
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003840
- Subject identifier
- D020528
- Condition
- Pain
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Atherosclerosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Premature Birth
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003917
- Subject identifier
- D047928
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Carpal Tunnel Syndrome
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0004143
- Subject identifier
- D002349
- Condition
- Keloid
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004212
- Subject identifier
- D007627
- Condition
- Diabetes, Gestational
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004593
- Subject identifier
- D016640
- Condition
- Acute Coronary Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005672
- Subject identifier
- D054058
- Condition
- Shock, Septic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0006834
- Subject identifier
- D012772
- Condition
- Persian Gulf Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007430
- Subject identifier
- D018923
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
And 29 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Condition identifier
- EFO_0000546
- Condition identifier
- EFO_0000612
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001072
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001073
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001358
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003047
- Condition identifier
- EFO_0003095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003840
- Condition identifier
- EFO_0003870
- Condition identifier
- EFO_0003913
- Condition identifier
- EFO_0003917
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003929
- Condition identifier
- EFO_0004269
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004352
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004593
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005672
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006834
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007067
- Highest recorded phase
- 1
- Condition identifier
- EFO_0007430
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007948
- Highest recorded phase
- 2
And 113 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- anti-insulin antibody increased
- Reports
- 22
- Reporting signal score
- 105.655
- Event
- anti-insulin antibody positive
- Reports
- 116
- Reporting signal score
- 467.874
- Event
- blindness
- Reports
- 97
- Reporting signal score
- 124.459
- Event
- blood glucose abnormal
- Reports
- 547
- Reporting signal score
- 1,337.97
- Event
- blood glucose decreased
- Reports
- 1,432
- Reporting signal score
- 3,895.22
- Event
- blood glucose fluctuation
- Reports
- 388
- Reporting signal score
- 1,018.12
- Event
- blood glucose increased
- Reports
- 5,167
- Reporting signal score
- 13,838.5
- Event
- clear cell renal cell carcinoma
- Reports
- 29
- Reporting signal score
- 98.3777
- Event
- device operational issue
- Reports
- 249
- Reporting signal score
- 941.292
- Event
- diabetes mellitus inadequate control
- Reports
- 913
- Reporting signal score
- 2,262.83
- Event
- diabetic ketoacidosis
- Reports
- 1,089
- Reporting signal score
- 2,055.87
- Event
- diabetic neuropathy
- Reports
- 50
- Reporting signal score
- 133.164
- Event
- diabetic retinopathy
- Reports
- 272
- Reporting signal score
- 805.938
- Event
- glycosylated haemoglobin increased
- Reports
- 797
- Reporting signal score
- 1,826.39
- Event
- hyperglycaemia
- Reports
- 1,171
- Reporting signal score
- 2,121.05
- Event
- hypoglycaemia
- Reports
- 4,944
- Reporting signal score
- 14,255
- Event
- hypoglycaemia neonatal
- Reports
- 162
- Reporting signal score
- 415.907
- Event
- hypoglycaemic coma
- Reports
- 494
- Reporting signal score
- 1,536.75
- Event
- hypoglycaemic seizure
- Reports
- 132
- Reporting signal score
- 426.496
- Event
- hypoglycaemic unconsciousness
- Reports
- 313
- Reporting signal score
- 1,157.76
- Event
- insulin resistance
- Reports
- 36
- Reporting signal score
- 119.694
- Event
- ketoacidosis
- Reports
- 270
- Reporting signal score
- 517.154
- Event
- low birth weight baby
- Reports
- 88
- Reporting signal score
- 183.557
- Event
- pharmaceutical product complaint
- Reports
- 81
- Reporting signal score
- 108.511
- Event
- premature baby
- Reports
- 500
- Reporting signal score
- 504.361
And 2 more, listed on the interactive page.
- NCT00000620
- NCT00006305
- NCT00032487
- NCT00099333
- NCT00110864
- NCT00143338
- NCT00174668
- NCT00191581
- NCT00242372
- NCT00246623
- NCT00282971
- NCT00325364
- NCT00330473
- NCT00331604
- NCT00332488
- NCT00332826
- NCT00343980
- NCT00348712
- NCT00355849
- NCT00367445
- NCT00370565
- NCT00375388
- NCT00384085
- NCT00391209
- NCT00411892
And 416 more, listed on the interactive page.
- Dose
- 4 units
- Route
- Inhalation
- How often
- At the beginning of each meal
- Discard inhaler after 15 days of use
- Use a single inhalation per cartridge
- Use more than one cartridge if dose exceeds contents of a single cartridge
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- FVNQHLCGSHLVEALYLVCGERGFFYTPKT
- Component
- Light chain
- Type
- Protein
- Sequence
- GIVEQCCTSICSLYQLENYCN
- 0002-8824
- 0338-0126
- 47918-874
- 47918-878
- 47918-880
- 47918-891
- 47918-898
- 47918-902
- 47918-904
Related records
Trials (362)
- A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
- A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
- A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
- A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
- A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
- A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
- A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
- A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
- A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes
- A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
- A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
- A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
- A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
- A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
- A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
- A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
- A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
- A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961
Approved for (2)
In development for (45)
- Acute coronary syndrome Phase 3
- Acute kidney injury Phase 2
- Acute myocardial infarction Phase 3
- Alcohol dependence Phase 1
- Atherosclerosis Phase 3
- Bipolar disorder Phase 3
- Burn Phase 2
- Cardiac arrest Phase 1
- Carpal tunnel syndrome Early phase 1
- Chronic progressive multiple sclerosis Phase 1
- Congestive heart failure Phase 3
- Coronary artery disorder Phase 3
- COVID-19 Phase 1
- Delirium Phase 1
- Diabetic kidney disease Phase 2
- Diabetic neuropathy Phase 2
- Dry eye syndrome Phase 1
- Frontotemporal dementia Phase 2
- Gestational diabetes Phase 3
- Glaucoma Phase 1
Other linked conditions (3)
- Brain aneurysm
- Diabetic ketoacidosis
- Hepatitis C virus infection
Targets (1)
- INSR Insulin receptor agonist