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Insulin for Human

Insulin for Human

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Modality

Insulin

Insulin, a hormone composed of 51 amino acids and produced by the β-cells of the islets of Langerhans, plays a crucial role in regulating blood glucose levels and participating in various metabolic processes. It promotes glycogen synthesis in the liver and muscles, facilitates fatty acid synthesis in adipocytes, and inhibits glycogenolysis and gluconeogenesis. The therapeutic use of insulin is primarily for the management of type 1 diabetes, an autoimmune metabolic disorder characterized by deficient or absent insulin production. However, in some cases, insulin may also be used for type 2 diabetes, where ineffective insulin production is observed. This highlights the importance of insulin in managing diabetes and maintaining overall metabolic health.

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Fig 1. Amino acid sequences of human insulin and insulin analogs

Development of Recombinant Insulin

Insulin was previously extracted from animal tissue, which had drawbacks such as immunogenicity, limited availability, and the risk of contamination. Additionally, the amino acid sequence of insulin varies among different species. Large-scale production of insulin began with the introduction of recombinant-DNA technology, replacing the previous method of purifying insulin from the bovine and porcine pancreas.

The first human recombinant insulin was approved in 1982 and was the first drug created using genetic engineering techniques in Escherichia coli (E. coli). Since then, various recombinant insulins have been developed, primarily produced in E. coli, with some also produced in Saccharomyces cerevisiae (S. cerevisiae) and Pichia pastoris (P. pastoris).

Genetic engineering has also allowed to produce different types of recombinant insulin, known as insulin analogs, which have altered amino acid sequences compared to native human insulin. These insulin analogs have different pharmacokinetic and pharmacodynamic profiles and are categorized as fast-acting (rapid-acting) or short-acting, intermediate-acting, and slow-acting or long-acting insulins. Fast-acting insulins increase blood insulin levels more rapidly, while slow-acting insulins enter the bloodstream more slowly but have a longer duration, helping to maintain basal insulin levels in the blood. Intermediate-acting insulin with specific activity has also been developed.

Duration of action

Insulin analogs

Structure

Available Products

Short-acting, or rapid-acting insulins

Human insulin

Native human insulin sequence

Humulin R (Lilly), Novolin R (Novo Nordisk), Actrapid (Novo Nordisk), Velosulin BR (Novo Nordisk), Afrezza (Sanofi), Insuman Rapid (Sanofi), Exubera (Pfizer), Insulin human (Winthrop), Solumarv (Marvel)

Intermediateacting insulins

Human insulin isophane

Native human insulin sequence

Humulin N (Lilly), Novolin N (Novo Nordisk), Insulatard (Novo Nordisk), Protaphane (Novo Nordisk), Insuman Comb (Sanofi)

Fast-acting insulins

Insulin lispro

Engineered insulin at B chain:Lys(B28), Pro(B29)

Humalog (Lilly), Liprolog (Lilly), Lyumjev (Lilly), Admelog (Sanofi)

Insulin aspart

Engineered insulin at B chain:Asp(B28)

NovoLog (Novo Nordisk), NovoRapid (Novo Nordisk), Fiasp (Novo Nordisk)

Insulin glulisine

Engineered insulin at B chain:Glu(B29), Lys(B3)

Apidra (Sanofi)

Long-acting or slow-acting insulins

Human insulin, zinc suspension

Native human insulin sequence

Monotard (Novo Nordisk), Ultratard (Novo Nordisk)

Insulin glargine

Engineered insulin at A and B chain:Gly(A21), Arg-Arg is inserted at the C-terminal of B chain

Lantus (Sanofi), Toujeo (Sanofi), Suliqua 100/33 (insulin glargine and lixisenatide, Sanofi), Basaglar (Lilly), Rezvoglar (Lilly), Lusduna (Merck), Semglee (Mylan)

Insulin detemir

Engineered insulin at B chain:C14 fatty acids are covalently linked to (B29) and Del(B30)

Levemir (Novo Nordisk)

Insulin degludec

Engineered insulin at B chain:C16 fatty acids are covalently linked to (B29)Lys and Del(B30)

Tresiba (Novo Nordisk), Xultophy 100/3.6 (insulin degludec and liraglutide,Novo Nordisk)

Insulin Icodec

Engineered insulin at A & B chains: LysB29(icosanedioic acid) A14E, B16H, B25H, desB30

Awiqli (Novo Nordisk)
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Insulin
Pipelines of Insulin
Generic Name Brand Name/ Alternative Name Expression System Manufacturer R&D Stage
Human insulin, recombinant Novolin R, NN-729, Novolin R, Actrapid, Velosulin BR, 诺和灵, ヒトインスリン(遺伝子組換え) Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Human insulin isophane Novolin N, Insulatard, Protaphane Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Human insulin, zinc suspension Monotard, Ultratard Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Insulin aspart NovoLog, NovoRapid, Fiasp, 诺和锐 Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
insulin aspart protamine + insulin aspart Biphasic insulin aspart, NovoMix, NovoLog Mix 50/50, 70/30 Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
insulin degludec Tresiba, IDeg, 诺和达, トレシーバ Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Insulin degludec+Liraglutide IDegLira, Tresiba, Insulin degludec/Victoza,诺和益, ゾルトファイ Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Insulin detemir Levemir, レベミル, 诺和平 Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Insulin Degludec+Insulin Aspart DegludecPlus, Ryzodeg 70/30, IDegAsp, NN1045,诺和佳 Yeast (Saccharomyces cerevisiae) Novo Nordisk Approval
Recombinant human insulin Humulin R, 优泌林 Escherichia coli (E. coli) Eli Lilly, Genentech Approval
Human insulin isophane Humulin N Escherichia coli (E. coli) Eli Lilly Approval
Lispro Insulin Humalog, Liprolog, 优泌乐, ルムジェブ Escherichia coli (E. coli) Eli Lilly Approval
lispro+protamine insulin Humalog Mix, Liprolog Mix, 优泌乐 Escherichia coli (E. coli) Eli Lilly Approval
Glargine Insulin Basagla, Rezvoglar, Abasaglar, インスリン グラルギン(遺伝子組換え) Escherichia coli (E. coli) Eli Lilly Approval
Recombinant human insulin Afrezza, Insuman Escherichia coli (E. coli) Sanofi Approval
Insulin lispro Admelog, SAR342434 Escherichia coli (E. coli) Sanofi Approval
Insulin glargine Lantus, Toujeo, 来得时 Escherichia coli (E. coli) Sanofi Approval
Insulin Glargine+Lixisenatide Suliqua 100/33, Glargine Insulin-recombination, Synthesis of Lixisenatide N.A. Sanofi, Genzyme, Zealand Pharma Approval
insulin glulisine Apidra Escherichia coli (E. coli) Sanofi, LifeScan Approval
Human isophane insulin Rinsulin Mix 30/70, Rinsulin NPH Pending update Geropharm Approval
Insulin Glargine Lusduna Escherichia coli (E. coli) Merck Approval, Withdrawn
Insulin aspart Pending update Pending update Geropharm Approval
Insulin human inhalation powder Afresa, Afrezza, Insulin, Insulin human, Insulin human (inhalation powder), Insulin inhalation, Technosphere Insulin, SAR-439065, Technosphere Insulin System E. coli (K12) MannKind Corporation, Sanofi Approval
Glargine Insulin Pending update Pending update PT Kalbe Farma Approval
Glargine Insulin bGlargine, Semglee Yeast (Pichia Pastoris) Viatris, Biocon Group, Mylan Approval
Insulin aspart bAspart Yeast (Pichia Pastoris) Viatris, Mylan, Biocon Group Approval
Human insulin, recombinant Inpremzia Yeast (Pichia Pastoris) Baxter, CELERITY PHARMS Approval
Glargine Insulin, biosimilar Pending update Yeast (Pichia Pastoris) HEC, Lannett Approval
lispro+protamine insulin 速秀霖® 25 Pending update Ganlee Approval
Insulin aspart 锐秀霖 Pending update Ganlee, Sandoz Approval
Lispro Insulin 速秀霖 Pending update Ganlee, Sandoz Approval
Glargine Insulin 长秀霖 Pending update Ganlee, Sandoz Approval
Human insulin, recombinant Pending update Pending update Hefei Tianmai Biotechnology Development Co., Ltd. Approval
Lispro Insulin Pending update Pending update Wanbang Biopharma Approval
Human insulin, recombinant Pending update Pending update Wanbang Biopharma Approval
Glargine Insulin Pending update Pending update Wanbang Biopharma, Fosun Pharma Approval
Human insulin, recombinant 优思灵 Pichia Pastoris The United Laboratories International Holdings Limited (TUL) Approval
Glargine Insulin Pending update Pending update MSD, Samsung Bioepis Approval
Insulin aspart 锐舒霖 Pending update Tonghua Dongbao Pharmaceutical Approval
Glargine Insulin Glargine insulin biosimilars (THTB), 平舒霖 Pending update Tonghua Dongbao Pharmaceutical Approval
Recombinant human insulin Pending update Pending update Tonghua Dongbao Pharmaceutical Approval
Glargine Insulin Pending update Pending update WOCKHARDT Approval
mecasermin INCRELEX Escherichia coli IPSEN, Genentech, Tercica Approval
Insulin aspart Pending update Pending update Zhejiang Hisun Pharmaceutical Co., Ltd Approval
Glargine Insulin Pending update Escherichia coli Chongqing Fujin, Lunan Pharmaceutical Approval
Insulin aspart 优倍灵 Yeast The United Laboratories International Holdings Limited (TUL) Approval
Glargine Insulin 优乐灵 Pending update The United Laboratories International Holdings Limited (TUL) Approval
Insulin prandial injectable Linjeta, VIAject Pending update Albireo Pharma, Biodel Submit for approval
Insulin Lispro GP40191 Pending update Geropharm Submit for approval
Insulin glargine GP40201 Pending update Geropharm Submit for approval
insulin Biosimilar Pending update Marvel Lifesciences Ltd Submit for approval
Insulin+Protamine Insulin Biosimilar Pending update HEC Submit for approval
Glargine Insulin Biosimilar Pending update Hefei Tianmai Biotechnology Submit for approval
insulin degludec Biosimilar Pending update Jilin Jinsheng, Huisheng Pharm, Hainan Sihuan Pharmaceutical, PEG-BIO Biopharm Submit for approval
lispro+protamine insulin Biosimilar Pending update Wanbang Biopharma, Fosun Pharma Submit for approval
insulin lispro LY900014 Pending update Eli Lilly Submit for approval
Glargine Insulin Biosimilar Pending update Liaoning Boao Bio Pharmaceutical, Lepu Medicdal Submit for approval
Insulin aspart Biosimilar Pending update Hainan Sihuan Pharmaceutical, Huisheng Pharm Submit for approval
insulin aspart protamine + insulin aspart Biosimilar Pending update Hainan Sihuan Pharmaceutical, Huisheng Pharm Submit for approval
insulin degludec Biosimilar Pending update Hainan Sihuan Pharmaceutical, Huisheng Pharm Submit for approval
Insulin aspart Biosimilar Pending update Hainan Sihuan Pharmaceutical, Huisheng Pharm Submit for approval
Icodec Insulin/NN9535 Pending update Pending update Novo Nordisk Phase III
Insulin icodec IA287, qw Preparation Yeast Novo Nordisk Phase III
Basal insulin-Fc Basal insulin-Fc, BIF, LY-3209590, LY 3209590, LY3209590 CHO cell Eli Lilly and Company Phase III
Insulin glargine HOE901-U300 Pending update Sanofi Phase III
Exubera Inhalated insulin, delisted Pending update Pfizer, Sanofi, Nektar Therapeutics Phase III
Insulin tregopil Pending update Pending update Biocon Group Phase III
ELGN-2112 Pending update Pending update Elgan Pharma Phase III
ELGN-2112 Pending update Pending update Elgan Pharma Phase III
Oral spray insulin Pending update Pending update Generex Biotechnology Phase III
insulin Pending update Pending update MannKind Corporation Phase III
Subetta adrugcontaining released-active forms of antibodies to the insulin receptor β-subunit and antibodies to endothelial nitric oxide synthase Pending update Materia Medica Holding Phase III
Oral Insulin-NTRA-2112 Oral Pending update Nutrinia Phase III
Intranasal Insulin Pending update Pending update Panamerican University Phase III
insulin aspart protamine + insulin aspart Pending update Pending update SL Pharm Phase III
insulin degludec Pending update Pending update HEC Phase III
Insulin Degludec+Insulin Aspart Pending update Pending update HEC Phase III
Insulin Degludec+Insulin Aspart Pending update Pending update Huisheng Pharm, Hainan Sihuan Pharmaceutical Co., ltd Phase III
insulin aspart protamine + insulin aspart Pending update Pending update Jilin JINsheng Phase III
INS068 Pending update Pending update Jiangsu Hengrui Pharmaceuticals , Luzsana Biotechnology, Chengdu Shengdi Phase III
insulin Pending update Pending update Merck, Merck Sharp & Dohme Phase III
insulin degludec Pending update Pending update Bovaxbio, Chenan Biopharm Phase III
Insulin Degludec+Insulin Aspart Pending update Pending update Hainan Sihuan Pharmaceutical Co., ltd, Huisheng Pharm Phase III
Insulin+Protamine Insulin Pending update Pending update Hainan Sihuan Pharmaceutical Co., ltd, Huisheng Pharm Phase III
Protamine Insulin Pending update Pending update Hainan Sihuan Pharmaceutical, Huisheng Pharm Phase III
lispro+protamine insulin Pending update Pending update Tonghua Dongbao Pharmaceutical Phase III
BC Lispro-THDB0206 Ultra-Rapid-Acting BC Lispro Pending update Tonghua Dongbao Pharmaceutical, Adocia Phase III
Insulin enteric-coated pills Pending update Pending update FOSSE BIO, Tsinghua University Phase III
Oral Insulin-ORMD-0801 Oral insulin-ORMD-0801 (PODTM) Pending update Oramed Pharmaceuticals Phase III
Human insulin Pending update Pending update Zhejiang Hisun Pharmaceutical Co., Ltd Phase III
Glargine Insulin Pending update Pending update Zhejiang Hisun Pharmaceutical Co., Ltd Phase III
insulin degludec Pending update Pending update CTTQ Pharma Phase III
insulin degludec Pending update Pending update The United Laboratories International Holdings Limited (TUL) Phase III
Insulin intranasal Intranasal insulin Pending update Adhera Therapeutics, MDRNA Phase II
Insulin Lispro+Pramlintide Compound-Omit Pending update Adocia Phase II
insulin Inhaled-AER 501 Inhaled insulin Pending update Aerami Therapeutics Phase II
BIOD-123 New formulation, Rapid-onset Pending update Albireo Pharma, Biodel Phase II
intranasal insulin Intranasal insulin Pending update Biocon Group, Cpex Pharmaceuticals Phase II
HDV Insulin Lispro Preparation Pending update Diasome Pharmaceuticals Phase II
Lispro-PH20 Subcutaneous drug delivery Pending update Halozyme Therapeutics Phase II
Aspart-PH20 Pending update Pending update Halozyme Therapeutics Phase II
Insulin338 Oral insulin Pending update Merrion Pharmaceuticals, Novo Nordisk Phase II
Oral insulin Oral Pending update Oshadi Drug Administration Phase II
Super-Long-Acting Basal Insulin-PE0139 Super-Long-Acting, fusion protein Pending update PhaseBio Pharmaceuticals Phase II
Pramlintide+ insulin XP3924 Pending update Xeris Pharmaceuticals Phase II
BMS-754807 Pending update Pending update Bristol Myers Squibb Phase II
Compound:基础长效胰岛素+GLP-1 HR17031 Pending update Jiangsu Hengrui Pharmaceuticals Co., Ltd Phase II
Insulin Glargine+Insulin Lispro BC Combo THDB 0207, BioChaperone Combo Pending update Tonghua Dongbao Pharmaceutical Co., Ltd, Adocia Phase II

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