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Oral Mucositis (OM) Therapeutics – Pipeline Analysis 2019

Oral Mucositis (OM) Therapeutics – Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments

Report Code: 40243 Published: October 2019 Pages: 200 Available format: 
Therapeutic Area(s): Oncology Report Type: Indication Pipeline Reports
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Chapter 1. Research Background

1.1 Research Objectives

1.2 Definition

1.3 Research Scope

1.3.1 Marketed Drugs by Route of Administration

1.3.2 Pipeline Drugs by Phase

1.3.3 Pipeline 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 Key Opinion Leaders (KOLs) Validation

2.3 Coverage of Epidemiology Analysis

2.4 Forecast Methodology

2.5 Assumptions for the Study

Chapter 3. Executive Summary

3.1 KOLs Opinions

Chapter 4. Introduction

4.1 Disease Overview

4.2 Causes and Risk Factors

4.3 Signs and Symptoms

4.4 Pathophysiology

4.5 Treatment

4.6 Key Drivers

4.6.1 Rising Incidence of HNC

4.6.2 Increasing Awareness

4.6.3 Rising R&D Investments

4.6.4 Positive Clinical Results of Pipeline Drugs

4.6.5 Growing Development of Small Molecule Therapeutics

4.7 Key Barriers

4.7.1 Risk of Complications from Radiation for HNC

4.7.2 Case of HPV Patients

4.7.3 Research on Cancer Prevention Vaccines/Modalities

4.7.4 Availability of Alternative Treatment

4.8 Opportunities

4.8.1 OM Associated with Targeted Therapies and Immunotherapies

4.9 Drug Designations

4.10 Unmet Medical Needs

4.10.1 Improvement in Drug Efficacy

4.10.2 Increasing Usage of Available Approved Therapy

4.10.3 Need of Defined Treatment Algorithm

Chapter 5. OM Epidemiology Forecast for 7MMs

5.1 Epidemiology Forecast for 7MMs

5.1.1 By Severity

5.2 Epidemiology Forecast for the U.S.

5.2.1 By Severity

5.3 Epidemiology Forecast for EU5

5.3.1 By Severity

5.3.2 By Country

5.3.2.1 Germany

5.3.2.1.1 By severity

5.3.2.2 France

5.3.2.2.1 By severity

5.3.2.3 Italy

5.3.2.3.1 By severity

5.3.2.4 U.K.

5.3.2.4.1 By severity

5.3.2.5 Spain

5.3.2.5.1 By severity

5.4 Epidemiology Forecast for Japan

5.4.1 By Severity

Chapter 6. Pipeline Drugs Outlook

6.1 OM Pipeline Drugs Snapshot

6.1.1 Pipeline Drugs Snapshot by Phase

6.1.2 Pipeline Drugs Snapshot by Route of Administration

6.1.3 Pipeline Drugs Snapshot by Molecule Type

Chapter 7. Marketed Drugs Analysis

7.1 Marketed Drugs Profiles

7.1.1 GelX

7.1.1.1 Regulatory milestones

7.1.1.2 Clinical trials and results

7.1.1.3 Strategic development activities

7.1.2 NeutraSal

7.1.2.1 Strategic development activities

7.1.3 Xxxx

7.1.3.1 Dosage

7.1.3.2 Regulatory milestones

7.1.3.3 Clinical trials and results

7.1.3.4 Strategic development activities

7.1.4 Xxxx

7.1.4.1 Regulatory milestones

7.1.4.2 Clinical trials and results

7.1.4.3 Strategic development activities

7.1.5 Xxxx

7.1.5.1 Regulatory milestones

7.1.5.2 Clinical trials and results

7.1.5.3 Strategic development activities

7.1.6 Xxxx

7.1.6.1 Regulatory milestones

7.1.6.2 Clinical trials and results

7.1.6.3 Strategic development activities

7.1.6.4 Patent

7.1.7 Xxxx

7.1.7.1 Regulatory milestones

7.1.7.2 Clinical trials and results

7.1.7.3 Strategic development activities

7.1.8 Xxxx

7.1.8.1 Clinical trials and results

7.1.8.2 Strategic development activities

7.1.9 Xxxx

7.1.9.1 Clinical trials

Chapter 8. OM Therapeutics Pipeline Analysis by Phase

8.1 Phase III

8.1.1 Brilacidin

8.1.1.1 Pre-clinical studies

8.1.1.2 Clinical trials

8.1.1.3 Clinical results

8.1.1.4 Designation

8.1.1.5 Name change

8.1.1.6 Financing

8.1.1.7 Patent

8.1.2 Xxxx

8.1.2.1 Clinical trials

8.1.2.2 Clinical results

8.1.2.3 Designation

8.1.2.4 Patent

8.1.3 Xxxx

8.1.3.1 Clinical trials

8.1.3.2 Designation

8.1.4 Xxxx

8.1.4.1 Clinical trials

8.1.5 Xxxx

8.1.5.1 Clinical trials

8.1.5.2 Clinical results

8.1.5.3 Strategic development

8.1.5.4 Patent

8.2 Phase II

8.2.1 IZN-6N4

8.2.1.1 Clinical trials

8.2.1.2 Clinical results

8.2.2 Xxxx

8.2.2.1 Pre-clinical studies

8.2.2.2 Clinical trials

8.2.2.3 Clinical results

8.2.2.4 Strategic development activities

8.2.2.5 Designation

8.2.3 Xxxx

8.2.3.1 Clinical trials

8.2.3.2 Clinical results

8.2.3.3 Designation

8.2.3.4 Financing

8.2.3.5 Patent

8.2.4 Xxxx

8.2.4.1 Clinical trials

8.2.4.2 Designation

8.2.4.3 Patent

8.2.5 Xxxx

8.2.5.1 Clinical trials

8.2.5.2 Clinical results

8.2.6 Xxxx

8.2.6.1 Clinical trials

8.2.6.2 Patents

8.2.7 Xxxx

8.2.7.1 Clinical trials

8.2.7.2 Clinical results

8.2.8 Xxxx

8.2.9 Xxxx

8.2.9.1 Clinical trials

8.2.9.2 Clinical results

8.2.9.3 Strategic development

8.2.10 Xxxx

8.2.11 Xxxx

8.2.11.1 Clinical trials

8.2.11.2 Clinical results

8.3 Phase I

8.3.1 Nu-3

8.4 Pre-clinical

8.4.1 CVXL-0095

8.4.2 Xxxx

8.4.3 Xxxx

8.4.4 Xxxx

8.4.5 Xxxx

8.4.5.1 Pre-clinical studies

8.4.5.2 Clinical results

8.4.6 Xxxx

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. Clinical Trials Review

10.1 Clinical Trials by Geography

Chapter 11. Competitive Landscape

11.1 Summary of Strategic Development Activities

11.2 Attribute Analysis

11.2.1 Safety

11.2.2 Efficacy

11.2.3 Tolerability

11.3 Expected Launch Time of Phase III Clinical Stage Products

11.3.1 OM Market Size

11.3.2 Market Share of Phase III Drugs in 2024

11.4 SWOT Analysis

11.5 Key Strategies

11.5.1 Collaborations and Partnerships

11.5.2 Strategic Product Promotion

11.5.3 Product Acquisitions

11.6 Key Highlights

11.6.1 Rise in Funding for Smooth Phase Transition

11.6.2 Robust Product Approvals

11.7 Pharma Proff’s View

Chapter 12. Company Profiles

12.1 Sunstar Suisse SA

12.1.1 Business Overview

12.1.2 Product and Service Offerings

12.1.3 Key Financial Summary

12.2 Xxxx.

12.2.1 Business Overview

12.2.2 Product and Service Offerings

12.3 Xxxx

12.3.1 Business Overview

12.3.2 Product and Service Offerings

12.3.3 Key Financial Summary

12.4 Izun Pharmaceuticals Corporation

12.4.1 Business Overview

12.4.2 Product and Service Offerings

12.5 Xxxx

12.5.1 Business Overview

12.5.2 Product and Service Offerings

12.5.3 Key Financial Summary

12.6 Xxxx.

12.6.1 Business Overview

12.6.2 Product and Service Offerings

12.7 Xxxx

12.7.1 Business Overview

12.7.2 Product and Service Offerings

12.8 Innovation Pharmaceuticals Inc.

12.8.1 Business Overview

12.8.2 Product and Service Offerings

12.9 Xxxx

12.9.1 Business Overview

12.9.2 Product and Service Offerings

12.9.3 Key Financial Summary

12.10 Xxxx

12.10.1 Business Overview

12.10.2 Product and Service Offerings

12.11 Xxxx

12.11.1 Business Overview

12.11.2 Product and Service Offerings

12.12 Xxxx

12.12.1 Business Overview

12.12.2 Product and Service Offerings

12.12.3 Key Financial Summary

12.13 Xxxx

12.13.1 Business Overview

12.13.2 Product and Service Offerings

12.13.3 Key Financial Summary

12.14 Xxxx

12.14.1 Business Overview

12.14.2 Product and Service Offerings

12.15 Xxxx.

12.15.1 Business Overview

12.15.2 Product and Service Offerings

12.15.3 Key Financial Summary

12.16 Xxxx

12.16.1 Business Overview

12.16.2 Product and Service Offerings

Chapter 13. Appendix

13.1 Recently Organized/Held Seminars and Conferences

13.2 Upcoming Conferences

13.3 Sources & References

13.4 Abbreviations

13.5 Related Reports

 

List of Tables

 

TABLE 1 CAUSES OF OM

TABLE 2 OM EPIDEMIOLOGY IN 7MMS, ‘000 (2014–2018)

TABLE 3 OM EPIDEMIOLOGY IN 7MMS, ‘000 (2019–2024)

TABLE 4 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2014–2018)

TABLE 5 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2019–2024)

TABLE 6 OM EPIDEMIOLOGY IN THE U.S. (2014–2018)

TABLE 7 OM EPIDEMIOLOGY IN THE U.S. (2019–2024)

TABLE 8 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2014–2024)

TABLE 9 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2019–2024)

TABLE 10 OM EPIDEMIOLOGY IN EU5 (2014–2018)

TABLE 11 OM EPIDEMIOLOGY IN EU5 (2019–2024)

TABLE 12 OM INCIDENT CASES IN EU5, BY SEVERITY (2014–2018)

TABLE 13 OM INCIDENT CASES IN EU5, BY SEVERITY (2019–2024)

TABLE 14 OM EPIDEMIOLOGY IN GERMANY (2014–2018)

TABLE 15 OM EPIDEMIOLOGY IN GERMANY (2019–2024)

TABLE 16 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2014–2018)

TABLE 17 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2019–2024)

TABLE 18 OM EPIDEMIOLOGY IN FRANCE (2014–2018)

TABLE 19 OM EPIDEMIOLOGY IN FRANCE (2019–2024)

TABLE 20 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2014–2018)

TABLE 21 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2019–2024)

TABLE 22 OM EPIDEMIOLOGY IN ITALY (2014–2018)

TABLE 23 OM EPIDEMIOLOGY IN ITALY (2019–2024)

TABLE 24 OM INCIDENT CASES IN ITALY, BY SEVERITY (2014–2018)

TABLE 25 OM INCIDENT CASES IN ITALY, BY SEVERITY (2019–2024)

TABLE 28 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2014–2018)

TABLE 29 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2019–2024)

TABLE 30 OM EPIDEMIOLOGY IN SPAIN (2014–2018)

TABLE 31 OM EPIDEMIOLOGY IN SPAIN (2019–2024)

TABLE 32 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2014–2018)

TABLE 33 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2019–2024)

TABLE 34 OM EPIDEMIOLOGY IN JAPAN (2014–2018)

TABLE 35 OM EPIDEMIOLOGY IN JAPAN (2019–2024)

TABLE 36 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2014–2018)

TABLE 37 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2019–2024)

TABLE 38 DESCRIPTION OF GELX

TABLE 39 DESCRIPTION OF NEUTRASAL

TABLE 40 DESCRIPTION OF XXXX

TABLE 41 DESCRIPTION OF XXXX

TABLE 42 DESCRIPTION OF XXXX

TABLE 43 DESCRIPTION OF XXXX

TABLE 44 DESCRIPTION OF XXXX

TABLE 45 DESCRIPTION OF XXXX

TABLE 46 DESCRIPTION OF XXXX

TABLE 47 CLINICAL TRIALS OF XXXX

TABLE 48 DESCRIPTION OF BRILACIDIN

TABLE 49 CLINICAL TRIALS OF BRILACIDIN

TABLE 50 DESCRIPTION OF XXXX

TABLE 51 CLINICAL TRIALS OF XXXX

TABLE 52 DESCRIPTION OF XXXX

TABLE 53 CLINICAL TRIALS OF XXXX

TABLE 54 DESCRIPTION OF XXXX

TABLE 55 CLINICAL TRIALS OF XXXX

TABLE 56 DESCRIPTION OF XXXX

TABLE 57 CLINICAL TRIALS OF XXXX

TABLE 58 DESCRIPTION OF IZN-6N4

TABLE 59 CLINICAL TRIALS OF IZN-6N4

TABLE 60 DESCRIPTION OF XXXX

TABLE 61 CLINICAL TRIALS OF XXXX

TABLE 62 DESCRIPTION OF XXXX

TABLE 63 CLINICAL TRIALS OF XXXX

TABLE 64 DESCRIPTION OF XXXX

TABLE 65 CLINICAL TRIALS OF XXXX

TABLE 66 DESCRIPTION OF XXXX

TABLE 67 CLINICAL TRIALS OF XXXX

TABLE 68 DESCRIPTION OF XXXX

TABLE 69 CLINICAL TRIALS OF XXXX

TABLE 70 DESCRIPTION OF XXXX

TABLE 71 CLINICAL TRIALS OF XXXX

TABLE 72 DESCRIPTION OF XXXX

TABLE 73 DESCRIPTION OF XXXX

TABLE 74 CLINICAL TRIALS OF XXXX

TABLE 75 DESCRIPTION OF XXXX

TABLE 76 DESCRIPTION OF XXXX

TABLE 77 CLINICAL TRIALS OF XXXX

TABLE 78 DESCRIPTION OF NU-3

TABLE 79 DESCRIPTION OF CVXL-0095

TABLE 80 DESCRIPTION OF XXXX

TABLE 81 DESCRIPTION OF XXXX

TABLE 82 DESCRIPTION OF XXXX

TABLE 83 DESCRIPTION OF XXXX

TABLE 84 DESCRIPTION OF XXXX

TABLE 85 COLLABORATIONS AND LICENSING AGREEMENTS

TABLE 86 ACQUISITIONS

TABLE 87 ATTRIBUTE ANALYSIS

TABLE 88 EXPECTED LAUNCH TIME OF PHASE III CLINICAL STAGE PRODUCTS

TABLE 89 SUNSTAR SUISSE SA – AT A GLANCE

TABLE 90 SUNSTAR SUISSE SA – KEY FINANCIAL SUMMARY

TABLE 91 XXXX – AT A GLANCE

TABLE 92 XXXX – AT A GLANCE

TABLE 93 XXXX – KEY FINANCIAL SUMMARY

TABLE 94 IZUN PHARMACEUTICALS CORPORATION – AT A GLANCE

TABLE 95 XXXX – AT A GLANCE

TABLE 96 XXXX - PRODUCTS OFFERINGS

TABLE 97 XXXX – KEY FINANCIAL SUMMARY

TABLE 98 XXXX – AT A GLANCE

TABLE 99 XXXX – AT A GLANCE

TABLE 100 INNOVATION PHARMACEUTICALS INC. – AT A GLANCE

TABLE 101 XXXX – AT A GLANCE

TABLE 102 XXXX – KEY FINANCIAL SUMMARY

TABLE 103 XXXX – AT A GLANCE

TABLE 104 XXXX – AT A GLANCE

TABLE 105 PIPELINE PRODUCTS OF XXXX

TABLE 106 XXXX – AT A GLANCE

TABLE 107 PIPELINE PRODUCTS OF XXXX

TABLE 108 XXXX – KEY FINANCIAL SUMMARY

TABLE 109 XXXX – AT A GLANCE

TABLE 110 MARKETED PRODUCTS OF XXXX

TABLE 111 PIPELINE PRODUCTS OF XXXX

TABLE 112 XXXX – KEY FINANCIAL SUMMARY

TABLE 113 XXXX – AT A GLANCE

TABLE 114 XXXX – AT A GLANCE

TABLE 115 MARKETED PRODUCTS OF XXXX

TABLE 116 PIPELINE PRODUCTS OF XXXX

TABLE 117 XXXX – KEY FINANCIAL SUMMARY

TABLE 118 XXXX – AT A GLANCE

TABLE 119 PIPELINE PRODUCTS OF XXXX

TABLE 120 RECENTLY ORGANIZED SEMINARS AND CONFERENCES

TABLE 121 UPCOMING SEMINARS AND CONFERENCES

TABLE 122 SOURCES & REFERENCES

TABLE 123 ABBREVIATIONS

 

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 OM PATHOPHYSIOLOGY

FIG 6 UNMET NEEDS

FIG 7 TOTAL NUMBER OF INCIDENT CASES IN 7MM, ‘000 (2018 & 2024)

FIG 8 OM INCIDENT CASES IN 7MM (2014–2024)

FIG 9 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2014–2024)

FIG 10 OM EPIDEMIOLOGY IN THE U.S. (2014–2024)

FIG 11 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2014–2024)

FIG 12 OM EPIDEMIOLOGY IN EU5 (2014–2024)

FIG 13 OM INCIDENT CASES IN EU5, BY SEVERITY (2014–2024)

FIG 14 OM EPIDEMIOLOGY IN GERMANY (2014–2024)

FIG 15 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2014–2024)

FIG 16 OM EPIDEMIOLOGY IN FRANCE (2014–2024)

FIG 17 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2014–2024)

FIG 18 OM EPIDEMIOLOGY IN ITALY (2014–2024)

FIG 19 OM INCIDENT CASES IN ITALY, BY SEVERITY (2014–2024)

FIG 20 OM EPIDEMIOLOGY IN THE U.K. (2014–2024)

FIG 21 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2014–2024)

FIG 22 OM EPIDEMIOLOGY IN SPAIN (2014–2024)

FIG 23 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2014–2024)

FIG 24 OM EPIDEMIOLOGY IN JAPAN (2014–2024)

FIG 25 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2014–2024)

FIG 26 OM PIPELINE DRUGS SNAPSHOT, BY PHASE (2019)

FIG 27 OM PIPELINE DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2019)

FIG 28 OM THERAPEUTICS PIPELINE DRUGS SNAPSHOT, BY MOLECULE TYPE (2019)

FIG 29 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)

FIG 30 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)

FIG 31 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU

FIG 32 MARKETING AUTHORIZATION PROCEDURES IN EU

FIG 33 CENTRALIZED PROCEDURE FOR DRUG APPROVAL

FIG 34 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL

FIG 35 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL

FIG 36 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN

FIG 37 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY

FIG 38 EXPECTED LAUNCH TIME

FIG 39 GLOBAL OM MARKET, 2018 & 2024 ($M)

FIG 40 MARKET SHARE OF PHASE III DRUGS IN 2024

FIG 41 SUNSTAR SUISSE SA – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2018)

FIG 42 XXXX – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2018)

FIG 43 XXXX – REVENUE SPLIT BY GEOGRAPHY (2018)

FIG 44 XXXX – REVENUE SPLIT BY BUSINESS AREA AND GEOGRAPHY (2018)