> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/insulin-human-99c024c5-521b-478f-a4e1-d5705d2c66d8
> Record changed: 2026-10-13

# Insulin human

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

First approval year

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

## Development status

**First approval year**

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

**Drug name**

Insulin human

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

### Brand names (22)

- 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

### Other names (133)

- 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.

## Identifiers

**CAS registry numbers**

- 11061-68-0

**ChEMBL ID**

CHEMBL1201631

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

**PubChem compound IDs**

- 118984375

**RxNorm IDs (RxCUI)**

- 253182

**FDA ingredient codes (UNII)**

- 1Y17CTI5SR

### ATC classification codes (5)

- A10AB01
- A10AC01
- A10AD01
- A10AE01
- A10AF01

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201631)

## Regulatory information

### United States

**Applicant**

LILLY

**Approval date**

28 Oct 1982

**Application number**

BLA018780

### European Union

**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

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/insuman)

### Other regulatory facts

**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

### Drug classification

**Pharmacology name**

insulin

**Type**

Peptide

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral
- topical

### Mechanisms of action (2)

- **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

### Investigated indications (54)

- **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.

### Open Targets indications (138)

- **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

### Reported adverse events (27)

- **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.

### Trial references (441)

- NCT00000620  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000620)
- NCT00006305  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006305)
- NCT00032487  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00032487)
- NCT00099333  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00099333)
- NCT00110864  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00110864)
- NCT00143338  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00143338)
- NCT00174668  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174668)
- NCT00191581  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191581)
- NCT00242372  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00242372)
- NCT00246623  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00246623)
- NCT00282971  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00282971)
- NCT00325364  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00325364)
- NCT00330473  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00330473)
- NCT00331604  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00331604)
- NCT00332488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00332488)
- NCT00332826  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00332826)
- NCT00343980  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00343980)
- NCT00348712  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00348712)
- NCT00355849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00355849)
- NCT00367445  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00367445)
- NCT00370565  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00370565)
- NCT00375388  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00375388)
- NCT00384085  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00384085)
- NCT00391209  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00391209)
- NCT00411892  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00411892)

And 416 more, listed on the interactive page.

## Dosing

**Dose**

4 units

**Route**

Inhalation

**How often**

At the beginning of each meal

### Conditions of use (3)

- 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

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (2)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
FVNQHLCGSHLVEALYLVCGERGFFYTPKT
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
GIVEQCCTSICSLYQLENYCN

## National Drug Codes

- 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)

- [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md)
- [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md)

### In development for (45)

- [Acute coronary syndrome](https://trialight.com/data/condition/acute-coronary-syndrome-3d7c2c1f-86ca-5a25-913a-6f9a7e95f989.md) Phase 3
- Acute kidney injury Phase 2
- [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 3
- [Alcohol dependence](https://trialight.com/data/condition/alcohol-dependence-d26b3f0d-c0fb-5084-9194-e963df0e9179.md) Phase 1
- [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) Phase 3
- Bipolar disorder Phase 3
- Burn Phase 2
- [Cardiac arrest](https://trialight.com/data/condition/cardiac-arrest-aa5c0aed-2b70-5846-9872-ccd2a7b23670.md) Phase 1
- Carpal tunnel syndrome Early phase 1
- [Chronic progressive multiple sclerosis](https://trialight.com/data/condition/chronic-progressive-multiple-sclerosis-99de35e9-2d98-5ec1-815e-693482f47d80.md) Phase 1
- Congestive heart failure Phase 3
- [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 3
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 1
- Delirium Phase 1
- [Diabetic kidney disease](https://trialight.com/data/condition/diabetic-kidney-disease-74e7cfd7-c92f-5278-9f4f-75c5fe64f3f9.md) Phase 2
- Diabetic neuropathy Phase 2
- [Dry eye syndrome](https://trialight.com/data/condition/dry-eye-syndrome-41ae8541-7903-50ab-9b50-168da1d2f619.md) Phase 1
- Frontotemporal dementia Phase 2
- Gestational diabetes Phase 3
- [Glaucoma](https://trialight.com/data/condition/glaucoma-7a3c05c0-9871-55db-af74-962761181784.md) Phase 1

### Other linked conditions (3)

- Brain aneurysm
- Diabetic ketoacidosis
- Hepatitis C virus infection

### Targets (1)

- [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) Insulin receptor agonist

---

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