insulin lispro

Trade name: humalog

Recombinant proteinapproved

Approved

Jun 14, 1996

Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is delivered subcutaneously either by injection or from an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed. — Wikipedia

Clinical trial activity

573 trials · 187 clinical orgs · 4 marketing orgs

Phase 1
182
Phase 2
207
Phase 3
156
Phase 4
147

Earliest trial started Dec 1, 1989 (NCT00410033)

Timeline

1990s

  1. Jan 1, 1995

    Novo Nordisk — Earliest Phase 1 Sponsor(trial)

  2. Jun 14, 1996

    Eli Lilly — Earliest FDA Approval

  3. Jun 14, 1996

    Eli Lilly — NDA Organization

  4. Jan 1, 1997

    Novo Nordisk — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1997

    Novo Nordisk — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jun 7, 2000

    Novo Nordisk — NDA Secondary Org

2010s

  1. May 26, 2015

    Eli Lilly — NDA Secondary Org

  2. Sep 25, 2015

    Novo — NDA Secondary Org

  3. Dec 11, 2017

    Sanofi-Aventis — NDA Secondary Org

Indications

Mechanism of action

Combination products

  • humalog mix 50/50 kwikpen

    with insulin human

    Also known as humalog mix, humalog mix 50/50 pen, humalog mix 75/25 kwikpen, humalog mix 75/25 pen, novolog mix, novolog mix 70/30 flexpen, novolog mix 70/30 penfill

  • ryzodeg

    with insulin degludec

Approval history

  • approvedJun 14, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CCC(=O)O[C@@](Cc1ccccc1)(c1ccccc1)[C@@H](C)CN(C)C.O=S(=O)(O)c1ccc2ccccc2c1
Mol. weight
547.72 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 29866
  • 29866
  • aspart
  • aspart
  • aspart insulin
  • aspart insulin
  • aspart insulin
  • b28-aspart-insulin
  • b28-asp-insulin
  • b28-asp-insulin
  • biasp30
  • biasp30
  • biasp30
  • biasp 30
  • biod-123
  • biphasic insulin aspart 30
  • biphasic insulin aspart 30:70
  • humalog
  • humalog
  • humalog
  • humalog
  • humalog kwikpen
  • humalog kwikpen
  • humalog lispro
  • humalog pen
  • ina-x14
  • ina-x14
  • ina-x14
  • ins humalog
  • ins novorapid
  • insulin apart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart
  • insulin aspart protamine
  • insulin aspart protamine
  • insulin aspart protamine
  • insulin aspart protamine
  • insulin aspart protamine
  • insulin aspart protamine
  • insulin aspart protamine crystalline
  • insulin aspart protamine recombinant
  • insulin aspart protamine recombinant
  • insulin aspart recombinant
  • insulin aspart recombinant
  • insulin aspart recombinant
  • insulin aspart recombinant
  • insulin aspart recombinant
  • insulin, asp(b28)
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro
  • insulin lispro (genetical recombination)
  • insulin,lispro,human/rdna
  • insulin lispro protamine
  • insulin lispro protamine
  • insulin lispro protamine
  • insulin lispro protamine
  • insulin lispro protamine
  • insulin lispro protamine
  • insulin,lispro,protamine/rdna
  • insulin lispro protamine recombinant
  • insulin lispro protamine recombinant
  • insulin lispro (rdna origin)
  • insulin lispro recombinant
  • insulin lispro recombinant
  • insulin lispro recombinant
  • insulin lispro recombinant
  • insulin peglispro
  • insulin peglispro
  • insulin peglispro
  • insulin x14
  • insulin x14
  • insulin x14
  • levopropoxyphene napsylate
  • levopropoxyphene napsylate
  • levopropoxyphene napsylate anhydrous
  • levopropoxyphene napsylate anhydrous
  • liprolog
  • lispro insulin
  • ly2605541
  • ly2605541
  • ly900014
  • novolog
  • novolog
  • novolog
  • novolog
  • novolog
  • novolog flexpen
  • novolog flexpen
  • novolog innolet
  • novolog innolet
  • novolog mix 70:30
  • novolog penfill
  • novolog penfill
  • novomix
  • novomix
  • novomix 30
  • novorapid
  • novorapid
  • novorapid
  • novrad
  • novrad

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07165652Phase 1Oct 13, 2025Xentria, Inc.
NCT07171684N/AOct 1, 2025Rutgers University
NCT07109245Phase 4Sep 1, 2025The Physicians' Services Incorporated Foundation, University of Toronto
NCT06945406Phase 1May 16, 2025Eli Lilly
NCT06854861Phase 1/Phase 2 (Phase 2)Apr 1, 2025Norwegian University of Science and Technology
NCT06600776Phase 4Oct 6, 2024Tel Aviv University
NCT06532461N/AJul 20, 2024Steno Diabetes Center Copenhagen
NCT06251635N/AJun 3, 2024University of Toronto
NCT06280703Phase 1May 15, 2024Eli Lilly
NCT06370715Phase 4Apr 18, 2024Cipla, Eli Lilly
NCT07257627Phase 1Apr 17, 2024Tonghua Dongbao Pharmaceutical Co.,Ltd
NCT06765655N/AApr 9, 2024St. Peter's Hospital, Albany, NY
NCT06931041Phase 3Feb 1, 2024University of Valencia
NCT06238778Phase 2Jan 23, 2024Diasome Pharmaceuticals, State University of New York, Syracuse
NCT05689424Phase 1Jan 10, 2024The Leona M. and Harry B. Helmsley Charitable Trust, University of California, San Diego
NCT06046417Phase 2/Phase 3 (Phase 3)Nov 30, 2023Juvenile Diabetes Research Foundation, McGill University
NCT05893797N/AOct 5, 2023Eli Lilly
NCT05660941N/AMar 1, 2023University of Manchester
NCT05508061N/AOct 19, 2022Inreda Diabetic B.V., Rijnstate Hospital
NCT05462756Phase 3Aug 11, 2022Eli Lilly
Showing 20 of 573 trials
Page 1 / 29

Organizations

Research & Development (187)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Novo NordiskFor profit21919851989
Eli LillyFor profit12611452001
Profil GmbHFor profit37332002
AdociaFor profit252422012
SanofiFor profit231852001
Emory UniversityAcademic/Hospital151422006
BiodelFor profit121132006
Halozyme TherapeuticsFor profit111132007
Tonghua Dongbao Pharmaceutical Co.,LtdFor profit8522015
Aarhus UniversityAcademic/Hospital7642006
Boehringer IngelheimFor profit7022011
MannKind CorpFor profit7732006
MerckFor profit7532011
Rush UniversityAcademic/Hospital7522005
Medical University of GrazAcademic/Hospital6532008
AstraZenecaFor profit5532003
Diasome PharmaceuticalsFor profit5512016
Harvard UniversityAcademic/Hospital5222014
Medical University of WarsawAcademic/Hospital5512011
GeropharmFor profit4422016
187 organizations
Page 1 / 10

Marketing (6)

OrganizationOrg typeRelationshipDate
Eli LillyFor profitNDA2May 26, 2015
Eli LillyFor profitSYNJun 14, 1996
Eli LillyFor profitNDAJun 14, 1996
NovoFor profitNDA2Sep 25, 2015
Novo NordiskFor profitNDA2Jun 7, 2000
Sanofi-AventisFor profitNDA2Dec 11, 2017