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insulin human

Trade name: humulin

Recombinant proteinapproved

Approved

Oct 28, 1982

Human Insulin, also known as Regular Insulin, is a short-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Human insulin is produced by recombinant DNA technology and is identical to endogenously produced insulin. Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis. Human insulin begins to exert its effects within 30 minutes of subcutaneous administration, while peak levels occur 3-4 hours after administration. Due to its quick onset of action, human insulin is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia. — NCATS

Clinical trial activity

1,057 trials · 595 clinical orgs · 8 marketing orgs

Phase 1
189
Phase 2
361
Phase 3
217
Phase 4
253

Earliest trial started Sep 1, 1982 (NCT02138006)

Timeline

1980s

  1. Oct 28, 1982

    Earliest FDA Approval

  2. Oct 28, 1982

    Eli Lilly — NDA Secondary Org

  3. Aug 30, 1983

    Novo Nordisk — NDA Secondary Org

  4. Mar 11, 1988

    Bayer — Marketing Organization

  5. Mar 11, 1988

    Bayer — NDA Secondary Org

1990s

  1. Apr 29, 1992

    Eli Lilly — First NDA Organization

  2. Apr 29, 1992

    Eli Lilly — NDA Organization

  3. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 1995

    Novo Nordisk — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 27, 2006

    Pfizer — NDA Secondary Org

2010s

  1. Jun 27, 2014

    MannKind Corp — NDA Secondary Org

  2. Jun 20, 2019

    Baxalta — NDA Secondary Org

  3. Jun 20, 2019

    Capstone Therapeutics — Marketing Organization

  4. Jun 20, 2019

    Baxter — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • humalog mix 50/50 kwikpen

    with insulin lispro

    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

Approval history

  • approvedOct 28, 1982

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • actrapid insulin
  • actrapid insulin
  • actrapid insulin
  • basal insulin
  • biod-125
  • biod-531
  • biphasic human insulin
  • cp-464,005
  • crystalline (aqueous suspension)
  • exubera
  • exubera
  • exubera
  • gik
  • glucose-insulin-potassium
  • glucose potassium insulin
  • high molecular weight insulin human
  • hm12460a
  • hoe21ph
  • human insulin
  • human insulin
  • human insulin
  • human insulin (rdna)
  • human recombinant insulin
  • humulin
  • humulin
  • humulin
  • humulin
  • humulin br
  • humulin l
  • humulin n
  • humulin r
  • humulin r
  • humulin r pen
  • humulin s
  • humulin u
  • iletin i
  • iletin i
  • iletin ii
  • ins hum insulat
  • ins hum protaphane
  • ins humulin i
  • ins humulin r
  • ins humulin zn
  • ins innolet insulat
  • ins insulat
  • ins insulat novolet
  • ins insuman basal
  • ins insuman basal optiset
  • ins insuman basal solostar
  • ins novolet hum protaphane
  • ins pur-in hum isop
  • insulatard nph human
  • insulin
  • insulin
  • insulin
  • insulin, 8a-l-threonine-10a-l-isoleucine-
  • insulin human
  • insulin human
  • insulin human
  • insulin human
  • insulin human
  • insulin human
  • insulin human
  • insulin (human)
  • insulin (human)
  • insulin (human)
  • insulin, human
  • insulin human base
  • insulin human base
  • insulin human base
  • insulin human (biosynthesis)
  • insulin human (biosynthesis)
  • insulin human (genetical recombination)
  • insulin human isophane
  • insulin human [rdna origin]
  • insulin human, rdna origin
  • insulin human regular
  • insulin human regular (rdna)
  • insulin human (synthesis)
  • insulin injection
  • insulin injection
  • insulin insulatard
  • insulin isophane
  • insulin isophane
  • insulin, isophane
  • insulin, neutral
  • insulin nph
  • insulin nph
  • insulin (ox), 8(a)-l-threonine-10(a)-l-isoleucine-
  • insulin recombinant human
  • insulin recombinant human
  • insulin recombinant human
  • insulin recombinant human
  • insulin recombinant human
  • insulin recombinant purified human
  • insulin recombinant purified human
  • insulin recombinant purified human
  • insulin recombinant purified human
  • insulin regular
  • insulin susp isophane recombinant human
  • insulin susp isophane recombinant human
  • insulin susp isophane semisynthetic purified human
  • insulin susp isophane semisynthetic purified human
  • insulin zinc, extended
  • insulin zinc injection, crystalline (aqueous suspension)
  • insulin zinc suspension (crystalline)
  • insulin zinc susp recombinant human
  • insulin zinc susp recombinant human
  • insulin zinc susp semisynthetic purified human
  • insulin zinc susp semisynthetic purified human
  • insuln
  • ins ultrat
  • ins ultrat mc
  • insuman infusat
  • isophane (aqueous suspension)
  • isophane insulin
  • isophane insulin
  • isophane insulin
  • ly041001
  • nasulin
  • neutral insulin
  • nnc 0123-0000-0338
  • novolin
  • novolin
  • novolin
  • novolin l
  • novolin n
  • novolin r
  • novo mc insulin
  • nph
  • nph
  • nph iletin
  • nph iletin
  • nph iletin ii
  • nph insulin
  • nph insulin
  • nph insulin
  • nph insulin
  • penfill
  • penfill
  • regular insulin
  • regular insulin
  • regular insulin, human
  • sar439065
  • technosphere
  • ultralente
  • ultralente
  • ultralente iletin
  • ultralente insulin
  • ultralente insulin
  • velosulin br
  • velosulin br human

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07293715Phase 4Jan 15, 2026Ohio State University
NCT07252752N/AJan 1, 2026Medical University of Vienna
NCT07224321Phase 2Dec 31, 2025Jaeb Center for Health Research, MannKind Corp
NCT07265323N/ADec 31, 2025Pennington Biomedical Research Center
NCT07259564Phase 2Dec 19, 2025GeneScience Pharmaceuticals Co., Ltd.
NCT07305805Phase 1Dec 15, 2025Novo Nordisk
NCT07090824Phase 1Oct 31, 2025Stanford University
NCT07193147Phase 1Oct 20, 2025Gan and Lee Pharmaceuticals, USA
NCT07165223Phase 3Oct 17, 2025Gan and Lee Pharmaceuticals, USA
NCT07039617N/ASep 2, 2025DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., University of Virginia
NCT07112339Phase 4Aug 15, 2025Novo Nordisk
NCT07146347Phase 1Aug 15, 2025Gan and Lee Pharmaceuticals, USA, Profil GmbH
NCT07056088N/AJul 31, 2025King Faisal University
NCT07068295Phase 1Jul 11, 2025Novo Nordisk
NCT06999551Phase 4Jul 1, 2025Les Laboratoires des Médicaments Stériles
NCT07007130N/AJun 1, 2025Ain Shams University
NCT06945406Phase 1May 16, 2025Eli Lilly
NCT06974487Phase 1May 8, 2025Gan and Lee Pharmaceuticals, USA
NCT06956846Phase 4Apr 25, 2025University of Paris
NCT06939959Phase 4Apr 14, 2025Khyber Medical University Peshawer
Showing 20 of 1,057 trials
Page 1 / 53

Organizations

Research & Development (595)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Novo NordiskFor profit1129051989
SanofiFor profit623151999
MannKind CorpFor profit484251999
Eli LillyFor profit382652002
Profil GmbHFor profit35222001
PfizerFor profit302541999
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government26451994
Emory UniversityAcademic/Hospital201842004
McGill UniversityAcademic/Hospital191942010
Gan and Lee Pharmaceuticals, USAFor profit161632022
University of TuebingenAcademic/Hospital141212008
University of CopenhagenAcademic/Hospital131042006
Aarhus UniversityAcademic/Hospital121142005
AstraZenecaFor profit12842004
Juvenile Diabetes Research FoundationAcademic/Hospital12052007
Mayo ClinicAcademic/Hospital12952000
MerckFor profit121242005
Sun Yat-Sen UniversityAcademic/Hospital121122004
University of MontrealAcademic/Hospital121222011
AlkermesFor profit11022003
595 organizations
Page 1 / 30

Marketing (10)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitNDA2Jun 20, 2019
BaxterFor profitNDA2Jun 20, 2019
BayerFor profitMKTGMar 11, 1988
BayerFor profitNDA2Mar 11, 1988
Capstone TherapeuticsFor profitMKTGJun 20, 2019
Eli LillyFor profitNDA2Oct 28, 1982
Eli LillyFor profitNDAApr 29, 1992
MannKind CorpFor profitNDA2Jun 27, 2014
Novo NordiskFor profitNDA2Aug 30, 1983
PfizerFor profitNDA2Jan 27, 2006