> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/insulin-lispro-bbdac1a5-6550-4dba-84b0-ef9312c83b13
> Record changed: 2026-10-13

# Insulin lispro

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

**Drug name**

Insulin lispro

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

### Brand names (10)

- humalog
- Humalog
- ins humalog
- Ins humalog
- insulin lispro sanofi
- Insulin lispro sanofi
- liprolog
- Liprolog
- Lyumjev (previously liumjev)
- lyumjev previously liumjev

### Other names (108)

- 28 sup b l lysine 29 sup b l prolineinsulin human
- 28(SUP B)-L-LYSINE-29(SUP B)-L-PROLINEINSULIN (HUMAN)
- admelog
- ADMELOG
- admelog solostar
- ADMELOG SOLOSTAR
- csii insulin lispro
- CSII(insulin Lispro)
- Humalog
- Humalog®
- identical to human insulin except for the transposition of proline and lysine at positions 28 and 29 on the b chain
- IDENTICAL TO HUMAN INSULIN EXCEPT FOR THE TRANSPOSITION OF PROLINE AND LYSINE AT POSITIONS 28 AND 29 ON THE B CHAIN
- INSULIN (HUMAN), 28(SUP B)-L-LYSINE-29(SUP B)-L-PROLINE-
- insulin b28 lys b29 pro recombinant human protamine sulphate
- INSULIN B28(LYS)-B29(PRO) RECOMBINANT HUMAN/PROTAMINE SULPHATE
- insulin human 28 sup b l lysine 29 sup b l proline
- insulin lispro
- Insulin lispro
- Insulin Lispro
- Insulin LISPRO
- INSULIN LISPRO (GENETICAL RECOMBINATION)
- Insulin Lispro (Humalog U-100)
- Insulin lispro (Humalog)
- Insulin Lispro (Humalog)
- Insulin Lispro (Humalog®)

And 83 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 133107-64-9

**ChEMBL ID**

CHEMBL1201538

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

**PubChem compound IDs**

- 118984450

**RxNorm IDs (RxCUI)**

- 86009

**FDA ingredient codes (UNII)**

- GFX7QIS1II

### ATC classification codes (3)

- A10AB04
- A10AC04
- A10AD04

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201538)

## Regulatory information

### United States

**Applicant**

LILLY

**Approval date**

14 Jun 1996

**Application number**

BLA020563

### European Union

**Status**

Authorised

**Status date**

30 Apr 1996

**Authorisation date**

30 Apr 1996

**Approved indications**

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

**Product number**

EMEA/H/C/000088

**Authorisation holder**

Eli Lilly Nederland B.V.

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

2

**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/humalog)

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

#### 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

### Investigated indications (4)

- **Condition**  
Diabetes Mellitus

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000400

**Subject identifier**  
D003920
- **Condition**  
Hyperglycemia

**Highest recorded phase**  
3

**Condition identifier**  
HP:0003074

**Subject identifier**  
D006943
- **Condition**  
Diabetes Mellitus, Type 1

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005147

**Subject identifier**  
D003922
- **Condition**  
Diabetes Mellitus, Type 2

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005148

**Subject identifier**  
D003924

### Open Targets indications (14)

- **Condition identifier**  
EFO\_0000400
- **Condition identifier**  
EFO\_1000653
- **Condition identifier**  
GO\_0006006

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0001943

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0003074

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004975
- **Condition identifier**  
MONDO\_0005015

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005147

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005148

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005300

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005406

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005468
- **Condition identifier**  
MONDO\_0006920

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0010030

**Highest recorded phase**  
3

### Reported adverse events (29)

- **Event**  
anti-insulin antibody positive

**Reports**  
36

**Reporting signal score**

141.877
- **Event**  
blindness

**Reports**  
134

**Reporting signal score**

143.459
- **Event**  
blood glucose abnormal

**Reports**  
236

**Reporting signal score**

632.013
- **Event**  
blood glucose decreased

**Reports**  
583

**Reporting signal score**  
1,690.27
- **Event**  
blood glucose fluctuation

**Reports**  
154

**Reporting signal score**

427.248
- **Event**  
blood glucose increased

**Reports**  
2,265

**Reporting signal score**  
6,686.35
- **Event**  
diabetes mellitus inadequate control

**Reports**  
311

**Reporting signal score**

770.892
- **Event**  
diabetic ketoacidosis

**Reports**  
474

**Reporting signal score**  
1,007.36
- **Event**  
diabetic neuropathy

**Reports**  
81

**Reporting signal score**

208.914
- **Event**  
diabetic retinopathy

**Reports**  
110

**Reporting signal score**

344.595
- **Event**  
glycosylated haemoglobin increased

**Reports**  
318

**Reporting signal score**

777.996
- **Event**  
hyperglycaemia

**Reports**  
432

**Reporting signal score**

815.6
- **Event**  
hypoglycaemia

**Reports**  
1,810

**Reporting signal score**  
5,359.15
- **Event**  
hypoglycaemia neonatal

**Reports**  
95

**Reporting signal score**

294.55
- **Event**  
hypoglycaemia unawareness

**Reports**  
24

**Reporting signal score**

102.035
- **Event**  
hypoglycaemic coma

**Reports**  
173

**Reporting signal score**

542.975
- **Event**  
hypoglycaemic seizure

**Reports**  
55

**Reporting signal score**

188.682
- **Event**  
hypoglycaemic unconsciousness

**Reports**  
124

**Reporting signal score**

477.371
- **Event**  
infusion site pain

**Reports**  
63

**Reporting signal score**

118.891
- **Event**  
insulin resistance

**Reports**  
50

**Reporting signal score**

154.847
- **Event**  
intercepted product selection error

**Reports**  
31

**Reporting signal score**

126.06
- **Event**  
ketoacidosis

**Reports**  
97

**Reporting signal score**

190.717
- **Event**  
low birth weight baby

**Reports**  
97

**Reporting signal score**

161.863
- **Event**  
pharmaceutical product complaint

**Reports**  
123

**Reporting signal score**

148.965
- **Event**  
premature baby

**Reports**  
339

**Reporting signal score**

551.463

And 4 more, listed on the interactive page.

### Trial references (127)

- NCT00046501  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00046501)
- NCT00071448  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00071448)
- NCT00348374  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00348374)
- NCT00467376  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00467376)
- NCT00705536  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00705536)
- NCT00862849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00862849)
- NCT01000922  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01000922)
- NCT01067118  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01067118)
- NCT01235039  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01235039)
- NCT01908894  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01908894)
- NCT02221323  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02221323)
- NCT02324309  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02324309)
- NCT04235439  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04235439)
- NCT00097071  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00097071)
- NCT00115570  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00115570)
- NCT00191581  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191581)
- NCT00487240  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00487240)
- NCT00553488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00553488)
- NCT00652288  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00652288)
- NCT00700622  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00700622)
- NCT00747006  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00747006)
- NCT00774800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00774800)
- NCT00883558  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00883558)
- NCT00993473  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00993473)
- NCT01035801  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01035801)

And 102 more, listed on the interactive page.

## Dosing

**Dose**

Unit dose (U-100 or U-200)

**Route**

Subcutaneous

**How often**

At the start of a meal or within 20 minutes after starting a meal

### Conditions of use (2)

- Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
- Rotate injection sites within the same region

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (2)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
FVNQHLCGSHLVEALYLVCGERGFFYTKPT
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
GIVEQCCTSICSLYQLENYCN

## National Drug Codes

- 0002-0800
- 0002-7510
- 0002-7511
- 0002-7516
- 0002-7712
- 0002-7714
- 0002-7726
- 0002-7728
- 0002-7737
- 0002-7752
- 0002-8207
- 0002-8213
- 0002-8222
- 0002-8228
- 0002-8233
- 0002-8235
- 0002-8351
- 0002-8797
- 0002-8798
- 0002-8799
- 0024-5924
- 0024-5925
- 0024-5926
- 50090-1375
- 50090-1663

And 5 more, listed on the interactive page.

## Related records

### Trials (262)

- 21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
- 24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
- 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
- A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
- A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
- A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
- A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
- A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
- A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
- A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
- A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
- 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 Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
- A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
- A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
- A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial
- A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
- A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
- A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)

### Approved for (1)

- [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md)

### In development for (3)

- Hyperglycemia Phase 3
- Type 1 diabetes mellitus Phase 3
- [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Phase 3

### Targets (1)

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

---

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