| Report Code: 40216 | Published: April 2019 | Pages: 291 | Available format: |
| Therapeutic Area(s): | Oncology | Immunology | Dermatology | Gastroenterology | Report Type: Mechanism of Action Reports |
Chapter 1. Research Background
1.1 Research Objectives
1.2 Definition
1.3 Research Scope
1.3.1 Pipeline Drugs by Phase
1.3.3 Pipeline and Marketed Drugs by Route of Administration
1.4 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown of Primary Research Respondents
2.2.1.1 By industry participant
2.2.1.2 By geography
2.2.1.3 By designation
2.2.2 KOLs Validation
Chapter 3. Executive Summary
3.1 Voice of KOLs
Chapter 4. Introduction
4.1 Characteristic Structural Features
4.2 Classification of JAK Proteins
4.3 Mechanism of Action
4.4 Key Drivers
4.4.1 Increasing Prevalence of JAK-STAT Malfunctioning Related Diseases
4.4.2 Expanding R&D Activities for JAK inhibitors
4.4.3 Growing Investments by Drug Manufacturers
4.5 Key Barriers
4.5.1 Stringent Regulations
4.5.2 Requirement of Technical Expertise
4.6 Technology Overview
4.6.1 Topical by Design Platform
4.6.2 DCE Platform
4.7 Drug Designations
Chapter 5. Pipeline and Marketed Drugs Outlook
5.1 JAK Inhibitors Pipeline and Marketed Drugs Snapshot
5.1.1 Pipeline Drugs Snapshot by Phase
5.1.2 Pipeline and Marketed Drugs Snapshot by Route of Administration
5.1.3 Pipeline and Marketed Drugs Snapshot by Company
Chapter 6. JAK Inhibitors Marketed Drugs Analysis
6.1 Marketed Drugs Profiles
6.1.1 Xeljanz
6.1.1.1 Dosage
6.1.1.2 Regulatory milestones
6.1.1.3 Clinical trials and results
6.1.1.3.1 UC
6.1.1.3.2 PsA
6.1.1.3.3 RA
6.1.1.4 Strategic development activities
6.1.1.5 Patents
6.1.1.6 Case study
6.1.2 Olumiant
6.1.2.1 Dosage
6.1.2.2 Regulatory milestones
6.1.2.3 Clinical trials and results
6.1.2.4 Strategic development activities
6.1.2.5 Designation
6.1.2.6 Patents
6.1.3 Jakafi
6.1.3.1 Dosage
6.1.3.2 Regulatory milestones
6.1.3.3 Clinical trials and results
6.1.3.3.1 MF
6.1.3.3.2 PV
6.1.3.4 Strategic development activities
6.1.3.5 Designation
6.1.3.6 Patents
6.1.3.7 Case study
6.2 Global Market Size and Share of JAK Inhibitors
6.2.1 Market Size
6.2.2 Market Share
6.3 Challenges Faced by Marketed Drug Manufacturers
6.3.1 Adverse Events (AE) Related to Drug Administration
6.3.2 Increasing Competition
6.3.3 High Cost of Drugs Targeting JAK
Chapter 7. Pipeline Products
7.1 Pre-Registration
7.1.1 Upadacitinib
7.1.1.1 Clinical trials
7.1.1.1.1 RA
7.1.1.1.2 PsA
7.1.1.1.3 UC
7.1.1.1.4 AD
7.1.1.1.5 CD
7.1.1.1.6 GCA
7.1.1.1.7 AS
7.1.1.1.8 JIA
7.1.1.2 Clinical results
7.1.1.2.1 RA
7.1.1.2.2 AD
7.1.1.2.3 CD
7.1.1.3 Strategic development activities
7.1.1.4 Designation
7.1.1.5 NDA 84
7.1.1.6 Patent
7.1.2 Pacritinib
7.1.2.1 Clinical trials
7.1.2.1.1 Lymphoproliferative disorders
7.1.2.1.2 MF
7.1.2.1.3 GvHD
7.1.2.2 Clinical trial results
7.1.2.3 Strategic development activities
7.1.2.4 NDA 90
7.1.2.5 Clinical hold
7.1.2.6 Designation
7.1.3 Delgocitinib
7.1.3.1 Clinical trials
7.1.3.1.1 AD
7.1.3.1.2 Chronic hand eczema
7.1.3.2 Clinical trial results
7.1.3.3 Strategic development activities
7.1.3.4 NDA 95
7.1.4 Peficitinib
7.1.4.1 Clinical trials
7.1.4.2 Clinical trial results
7.1.4.3 Strategic development activities
7.1.4.4 NDA 100
7.2 Phase III
7.2.1 Itacitinib
7.2.1.1 Pre-clinical studies
7.2.1.2 Clinical trials
7.2.1.2.1 Cancer
7.2.1.2.2 GvHD
7.2.1.2.3 UC
7.2.1.2.4 MF
7.2.1.3 Clinical results
7.2.1.4 Strategic development activities
7.2.1.5 Designations
7.2.1.6 Patents
7.2.2 Momelotinib
7.2.2.1 Clinical trials
7.2.2.2 Clinical results
7.2.2.3 Strategic development activities
7.2.2.4 Financing
7.2.2.5 Designations
7.2.2.6 Patents
7.2.3 Abrocitinib
7.2.3.1 Clinical trials
7.2.3.2 Clinical results
7.2.3.3 Designation
7.2.4 Filgotinib
7.2.4.1 Pre-clinical studies
7.2.4.2 Clinical trials
7.2.4.3 Clinical results
7.2.4.4 Strategic development activities
7.2.4.5 Designation
7.3 Phase II
7.3.1 TD-1473
7.3.1.1 Pre-clinical studies
7.3.1.2 Pre-clinical studies
7.3.1.3 Clinical trials
7.3.1.4 Clinical results
7.3.1.5 Strategic development activities
7.3.2 ATI-502
7.3.2.1 Clinical trials
7.3.2.2 Clinical results
7.3.2.3 Strategic development activities
7.3.2.4 Designations
7.3.2.5 Patent
7.3.3 ATI-501
7.3.3.1 Clinical trials
7.3.3.2 Clinical results
7.3.3.3 Strategic development activities
7.3.4 PF-06651600
7.3.4.1 Clinical trials
7.3.4.2 Clinical results
7.3.4.3 Designations
7.3.5 INCB052793
7.3.5.1 Pre-clinical studies
7.3.5.2 Clinical trials
7.3.5.3 Clinical trial results
7.3.6 SNA 125
7.3.6.1 Pre-clinical studies
7.3.6.2 Clinical trials
7.3.6.3 Clinical results
7.3.6.4 Strategic development activities
7.3.6.5 Financing
7.3.6.6 Technology
7.3.7 PF-06700841
7.3.7.1 Clinical trials
7.3.7.2 Clinical results
7.3.8 Cerdulatinib
7.3.8.1 Pre-clinical studies
7.3.8.2 Clinical trials
7.3.8.3 Clinical results
7.3.8.4 Strategic development activities
7.3.8.5 Designation
7.3.8.6 Patent
7.3.9 CTP-543
7.3.9.1 Clinical trials
7.3.9.2 Clinical results
7.3.9.3 Designation
7.3.9.4 Technology
7.3.9.5 Clinical hold
7.3.9.6 Financing
7.3.10 SHR 0302
7.3.10.1 Pre-clinical studies
7.3.10.2 Clinical trials
7.3.10.3 Strategic development activities
7.3.11 Gandotinib
7.3.11.1 Clinical trials
7.3.11.2 Clinical results
7.3.12 INCB54707
7.3.12.1 Clinical trials
7.3.13 NS 018
7.3.13.1 Clinical trials
7.3.13.2 Clinical trial results
7.3.13.3 Strategic development activities
7.4 Phase I
7.4.1 TD-8236
7.4.1.1 Pre-clinical studies
7.4.1.2 Clinical trials
7.4.2 Jaktinib
7.4.2.1 Clinical trials
7.4.3 VR588
7.4.3.1 Pre-clinical studies
7.4.3.2 Clinical trials
7.4.4 AZD4205
7.4.4.1 Pre-clinical studies
7.4.4.2 Clinical trials
7.4.4.3 Strategic development activities
7.4.5 AZD0449
7.4.5.1 Clinical trials
7.4.5.2 Strategic development activities
7.4.6 LP0184
7.5 Pre-clinical
7.5.1 ITK/JAK3 Inhibitor
7.5.2 MA2-014
7.5.2.1 Pre-clinical studies
7.5.2.2 Strategic development activities
7.5.3 ATI-1777
7.5.3.1 Pre-clinical studies
7.5.4 ARN-4079
7.5.4.1 Pre-clinical studies
7.5.5 CVXL-0074
7.5.5.1 Strategic development activities
7.6 Discovery
7.6.1 OMT-003: Ohm Oncology
7.7 Inactive
7.8 Discontinued
Chapter 8. Clinical Trials Review
8.1 Clinical Trials by Geography
8.2 Clinical Trials by Trial Status
Chapter 9. Regulatory Framework for Drug Approval
9.1 U.S.
9.2 Europe
9.2.1 Centralized Procedure
9.2.2 Mutual Recognition Procedure
9.2.3 Decentralized Procedure
9.2.4 Nationalized Procedure
9.3 Japan
Chapter 10. Competitive Landscape
10.1 Summary of Strategic Development Activities
10.2 Comparative Analysis
10.3 Attribute Analysis
10.3.1 Upadacitinib and Delgocitinib
10.3.2 Upadacitinib and Peficitinib
10.4 Expected Launch Time of Phase III Clinical Stage Products
10.5 Key Winning Strategies
10.5.1 Technological Advancements
10.5.2 Collaborations and Partnerships
10.5.3 Development through Subsidiaries
10.5.4 Acquisition of Additional Pipeline Products
10.5.5 Expanding Research Focus
10.6 Pharma Proff’s View
Chapter 11. Company Profiles
11.1 Incyte Corporation
11.1.1 Business Overview
11.1.2 Product and Service Offerings
11.1.2.1 Marketed products
11.1.2.2 Pipeline products
11.2 CTI BioPharma Corp.
11.2.1 Business Overview
11.2.2 Product and Service Offerings
11.2.2.1 Marketed products
11.2.2.2 Pipeline products
11.3 LEO Pharma A/S
11.3.1 Business Overview
11.3.2 Product and Service Offerings
11.3.2.1 Marketed products
11.3.2.2 Pipeline products
11.4 AstraZeneca PLC
11.4.1 Business Overview
11.4.2 Product and Service Offerings
11.4.2.1 Marketed products
11.4.2.2 Pipeline products
11.5 Eli Lilly and Company
11.5.1 Business Overview
11.5.2 Product and Service Offerings
11.5.2.1 Marketed products
11.5.2.2 Pipeline products
11.6 Novartis AG
11.6.1 Business Overview
11.6.2 Product and Service Offerings
11.6.2.1 Marketed products
11.6.2.2 Pipeline products
11.7 Pfizer Inc.
11.7.1 Business Overview
11.7.2 Product and Service Offerings
11.7.2.1 Marketed products
11.7.2.2 Pipeline products
11.8 AbbVie Inc.
11.8.1 Business Overview
11.8.2 Product and Service Offerings
11.8.2.1 Marketed products
11.8.2.2 Pipeline products
11.9 Sierra Oncology Inc.
11.9.1 Business Overview
11.9.2 Product and Service Offerings
11.9.2.1 Pipeline products
11.10 Gilead Sciences Inc.
11.10.1 Business Overview
11.10.2 Product and Service Offerings
11.10.2.1 Marketed products
11.10.2.2 Pipeline products
11.11 Aclaris Therapeutics Inc.
11.11.1 Business Overview
11.11.2 Product and Service Offerings
11.11.2.1 Marketed products
11.11.2.2 Pipeline products
11.12 Portola Pharmaceuticals Inc.
11.12.1 Business Overview
11.12.2 Product and Service Offerings
11.12.2.1 Marketed products
11.12.2.2 Pipeline products
11.13 Concert Pharmaceuticals Inc.
11.13.1 Business Overview
11.13.2 Product and Service Offerings
11.13.2.1 Pipeline products
11.14 Reistone Biopharma Company Limited
11.14.1 Business Overview
11.14.2 Product and Service Offerings
11.15 Theravance Biopharma Inc.
11.15.1 Business Overview
11.15.2 Product and Service Offerings
11.15.2.1 Marketed products
11.15.2.2 Pipeline products
11.16 Sienna Biopharmaceuticals Inc.
11.16.1 Business Overview
11.16.2 Products and Service Offerings
11.16.2.1 Pipeline products
11.17 Aptose Biosciences Inc.
11.17.1 Business Overview
11.17.2 Pipeline Products Offerings
11.17.2.1 Pipeline products
11.18 Arrien Pharmaceuticals LLC
11.18.1 Business Overview
11.18.2 Products and Service Offerings
11.18.2.1 Pipeline products
11.19 Clevexel Pharma SA
11.19.1 Business Overview
11.19.2 Products and Service Offerings
11.19.2.1 Pipeline products
11.20 Suzhou Zelgen Biopharmaceuticals Co. Ltd.
11.20.1 Business Overview
11.20.2 Products and Service Offerings
11.20.2.1 Pipeline products
11.21 Nippon Shinyaku Co. Ltd.
11.21.1 Business Overview
11.21.2 Product and Service Offerings
11.21.2.1 Marketed products
11.21.2.2 Pipeline products
Chapter 12. Appendix
12.1 Recently Organized/Held Seminars and Conferences
12.2 Upcoming Conferences
12.3 Sources & References
12.4 Abbreviations
12.5 Related Reports
LIST OF TABLES
TABLE 1 DESIGNATION
TABLE 2 DESCRIPTION OF XELJANZ
TABLE 3 RECOMMENDED DOSAGE OF XELJANZ AND XELJANZ XR IN PATIENTS WITH RA AND PSA
TABLE 4 RECOMMENDED DOSAGE OF XELJANZ IN PATIENTS WITH UC
TABLE 5 OTHER ACTIVE CLINICAL TRIALS OF TOFACITINIB
TABLE 6 XELJANZ PATENTS
TABLE 7 DESCRIPTION OF OLUMIANT
TABLE 8 OTHER ACTIVE CLINICAL TRIALS OF BARICITINIB
TABLE 9 OLUMIANT PATENTS
TABLE 10 DESCRIPTION OF JAKAFI
TABLE 11 OTHER ACTIVE CLINICAL TRIALS OF RUXOLITINIB
TABLE 12 JAKAFI PATENTS
TABLE 13 DESCRIPTION OF UPADACITINIB
TABLE 14 CLINICAL TRIALS OF UPADACITINIB
TABLE 15 DESCRIPTION OF PACRITINIB
TABLE 16 CLINICAL TRIALS OF PACRITINIB
TABLE 17 DESCRIPTION OF DELGOCITINIB
TABLE 18 CLINICAL TRIALS OF DELGOCITINIB
TABLE 19 DESCRIPTION OF PEFICITINIB
TABLE 20 CLINICAL TRIALS OF PEFICITINIB
TABLE 27 DESCRIPTION OF FILGOTINIB
TABLE 28 CLINICAL TRIALS OF FILGOTINIB
TABLE 37 DESCRIPTION OF INCB052793
TABLE 39 DESCRIPTION OF SNA-125
TABLE 40 DESCRIPTION OF PF-06700841
TABLE 41 CLINICAL TRIALS OF PF-06700841
TABLE 42 DESCRIPTION OF CERDULATINIB
TABLE 43 CLINICAL TRIALS OF CERDULATINIB
TABLE 46 DESCRIPTION OF SHR 0302
TABLE 47 CLINICAL TRIALS OF SHR 0302
TABLE 48 DESCRIPTION OF GANDOTINIB
TABLE 49 CLINICAL TRIALS OF GANDOTINIB
TABLE 63 CLINICAL TRIALS OF AZD0449
TABLE 66 DESCRIPTION OF ATI-1777
TABLE 67 DESCRIPTION OF ARN-4079
TABLE 68 DESCRIPTION OF CVXL-0074
TABLE 69 INACTIVE DRUG CANDIDATES
TABLE 70 DISCONTINUED DRUG CANDIDATES
TABLE 78 INCYTE CORPORATION – AT A GLANCE
TABLE 79 MARKETED PRODUCTS
TABLE 80 PIPELINE PRODUCTS
TABLE 81 CTI BIOPHARMA CORP. – AT A GLANCE
TABLE 82 PIPELINE PRODUCTS
TABLE 83 LEO PHARMA A/S – AT A GLANCE
TABLE 84 MARKETED PRODUCTS
TABLE 85 PIPELINE PRODUCTS
TABLE 86 ASTRAZENECA PLC – AT A GLANCE
TABLE 87 ELI LILLY AND COMPANY – AT A GLANCE
TABLE 88 MARKETED PRODUCTS
TABLE 89 PIPELINE PRODUCTS
TABLE 90 NOVARTIS AG – AT A GLANCE
TABLE 91 PIPELINE PRODUCTS
TABLE 92 PFIZER INC. – AT A GLANCE
TABLE 93 ABBVIE INC. – AT A GLANCE
TABLE 94 MARKETED PRODUCTS
TABLE 95 PIPELINE PRODUCTS
TABLE 96 SIERRA ONCOLOGY INC.– AT A GLANCE
TABLE 97 PIPELINE PRODUCTS
TABLE 98 GILEAD SCIENCES INC.– AT A GLANCE
TABLE 99 MARKETED PRODUCTS
TABLE 100 PIPELINE PRODUCTS
TABLE 101 ACLARIS THERAPEUTICS INC. – AT A GLANCE
TABLE 102 MARKETED PRODUCTS
TABLE 103 PIPELINE PRODUCTS
TABLE 104 PORTOLA PHARMACEUTICALS INC. – AT A GLANCE
TABLE 105 MARKETED PRODUCTS
TABLE 106 PIPELINE PRODUCTS
TABLE 108 PIPELINE PRODUCTS
TABLE 109 REISTONE BIOPHARMA COMPANY LIMITED– AT A GLANCE
TABLE 110 THERAVANCE BIOPHARMA INC. – AT A GLANCE
TABLE 111 MARKETED PRODUCTS
TABLE 112 PIPELINE PRODUCTS
TABLE 113 SIENNA BIOPHARMACEUTICALS INC. – AT A GLANCE
TABLE 114 PIPELINE PRODUCTS
TABLE 115 APTOSE BIOSCIENCES INC. – AT A GLANCE
TABLE 116 PIPELINE PRODUCTS
TABLE 117 ARRIEN PHARMACEUTICALS LLC – AT A GLANCE
TABLE 118 PIPELINE PRODUCTS
TABLE 119 CLEVEXEL PHARMA SA – AT A GLANCE
TABLE 120 PIPELINE PRODUCTS
TABLE 121 SUZHOU ZELGEN BIOPHARMACEUTICALS CO. LTD. – AT A GLANCE
TABLE 122 PIPELINE PRODUCTS
TABLE 123 NIPPON SHINYAKU CO. LTD. – AT A GLANCE
TABLE 124 PIPELINE PRODUCTS
TABLE 125 RECENTLY ORGANIZED SEMINARS AND CONFERENCES
TABLE 126 UPCOMING SEMINARS AND CONFERENCES
TABLE 127 SOURCES & REFERENCES
TABLE 128 ABBREVIATION
LIST OF FIGURES
FIG 1 RESEARCH METHODOLOGY
FIG 2 BREAKDOWN OF PRIMARY RESEARCH RESPONDENTS, BY INDUSTRY PARTICIPANT
FIG 3 BREAKDOWN OF PRIMARY RESEARCH, BY GEOGRAPHY
FIG 4 BREAKDOWN OF PRIMARY RESEARCH, BY DESIGNATION
FIG 5 CLASSIFICATION
FIG 6 MECHANISM OF ACTION
FIG 7 JAK INHIBITORS PIPELINE DRUGS SNAPSHOT, BY PHASE (2019)
FIG 8 JAK INHIBITORS PIPELINE AND MARKETED DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2019)
FIG 9 COMPANY BENCHMARKING BASED ON DRUG CANDIDATES
FIG 10 GLOBAL JAK INHIBITORS MARKET SIZE, $B (2018 & 2028)
FIG 11 MARKET SHARE OF JAK INHIBITORS MARKETED DRUGS (2018)
FIG 12 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY
FIG 13 BREAKDOWN OF CLINICAL TRIALS, BY TRIAL STATUS
FIG 14 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)
FIG 15 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)
FIG 16 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU
FIG 17 MARKETING AUTHORIZATION PROCEDURES IN EU
FIG 18 CENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 19 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL
FIG 20 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 21 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN
FIG 22 EXPECTED LAUNCH TIME