Sleep Disorders Drug Development Pipeline Review, 2017

This report provides an overview of the pipeline landscape for sleep disorders. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for Restless Legs Syndrome, Nocturia and Insomnia, and features dormant and discontinued projects.

Restless Legs Syndrome is a neurologic disorder with a core feature of a distressing, irresistible need or urge to move the legs. Risk factors for RLS include low iron levels, kidney failure, Parkinson’s disease, diabetes mellitus, rheumatoid arthritis, and pregnancy.

Nocturia, or nocturnal polyuria, describes the excessive urination during night time. Nocturia becomes more common with age and may be symptomatic of the use of diuretic substances, prescription drugs, edema from heart failure, insomnia, pain and prostate or bladder disorders.

Finally, insomnia is a sleep disorder that is characterized by difficulty in falling or staying asleep. Symptoms include difficulty falling asleep at night, waking up during the night, irritability, depression and anxiety.

The size of these pipelines ranges from eight products in restless legs syndrome and nocturia to 31 in insomnia. Across all three of these indications there is a diverse range of molecular targets due to the different pathologies of the indications. The most common targets for restless legs syndrome, nocturia and insomnia therapeutics are D2 dopamine receptor, vasopressin V2 receptor and orexin receptor, respectively.

Scope

– Which companies are the most active within the pipeline for sleep disorder therapeutics?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in the field of sleep disorders?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication, and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline, and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 7

2.1 Sleep Disorders Report Coverage 7

2.2 Restless Legs Syndrome - Overview 7

2.3 Nocturia - Overview 7

2.4 Insomnia - Overview 7

3 Therapeutics Development 8

3.1 Restless Legs Syndrome 8

3.2 Nocturia 11

3.3 Insomnia 14

4 Therapeutics Assessment 21

4.1 Restless Legs Syndrome 21

4.2 Nocturia 27

4.3 Insomnia 33

5 Companies Involved in Therapeutics Development 39

5.1 Restless Legs Syndrome 39

5.2 Nocturia 42

5.3 Insomnia 44

6 Dormant Projects 53

6.1 Restless Legs Syndrome 53

6.2 Nocturia 53

6.3 Insomnia 54

7 Discontinued Products 56

7.1 Restless Legs Syndrome 56

7.2 Insomnia 56

8 Product Development Milestones 58

8.1 Restless Legs Syndrome 58

8.2 Nocturia 63

8.3 Insomnia 64

9 Appendix 75

9.1 Methodology 75

9.2 Coverage 75

9.3 Secondary Research 75

9.4 Primary Research 75

9.5 Expert Panel Validation 75

9.6 Contact Us 76

9.7 Disclaimer 76

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Restless Legs Syndrome 8

Table 2: Number of Products under Development by Companies Restless Legs Syndrome 9

Table 3: Products under Development by Companies Restless Legs Syndrome 10

Table 4: Number of Products under Development for Nocturia 11

Table 5: Number of Products under Development by Companies Nocturia 12

Table 6: Products under Development by Companies Nocturia 13

Table 7: Number of Products under Development for Insomnia 14

Table 8: Number of Products under Development by Companies Insomnia 16

Table 9: Number of Products under Development by Universities/Institutes Insomnia 17

Table 10: Products under Development by Companies Insomnia 18

Table 11: Products under Development by Universities/Institutes Insomnia 20

Table 12: Number of Products by Stage and Target Restless Legs Syndrome 22

Table 13: Number of Products by Stage and Mechanism of Action Restless Legs Syndrome 23

Table 14: Number of Products by Stage and Route of Administration Restless Legs Syndrome 25

Table 15: Number of Products by Stage and Molecule Type Restless Legs Syndrome 26

Table 16: Number of Products by Stage and Target Nocturia 28

Table 17: Number of Products by Stage and Mechanism of Action Nocturia 29

Table 18: Number of Products by Stage and Route of Administration Nocturia 31

Table 19: Number of Products by Stage and Molecule Type Nocturia 32

Table 20: Number of Products by Stage and Target Insomnia 34

Table 21: Number of Products by Stage and Mechanism of Action Insomnia 36

Table 22: Number of Products by Stage and Route of Administration Insomnia 38

Table 23: Number of Products by Stage and Molecule Type Insomnia 38

Table 24: Restless Legs Syndrome – Pipeline by Galenica Ltd 39

Table 25: Restless Legs Syndrome – Pipeline by Hisamitsu Pharmaceutical Co Inc 39

Table 26: Restless Legs Syndrome – Pipeline by Merz Pharma GmbH & Co KgaA 40

Table 27: Restless Legs Syndrome – Pipeline by Mundipharma International Ltd 40

Table 28: Restless Legs Syndrome – Pipeline by Omeros Corp 41

Table 29: Restless Legs Syndrome – Pipeline by Serina Therapeutics Inc 41

Table 30: Nocturia – Pipeline by Astellas Pharma Inc 42

Table 31: Nocturia – Pipeline by Ferring International Center SA 42

Table 32: Nocturia – Pipeline by Sanwa Kagaku Kenkyusho Co Ltd 43

Table 33: Nocturia – Pipeline by Vantia Therapeutics 43

Table 34: Insomnia – Pipeline by Alexza Pharmaceuticals Inc 44

Table 35: Insomnia – Pipeline by Athenex Inc 44

Table 36: Insomnia – Pipeline by Eisai Co Ltd 45

Table 37: Insomnia – Pipeline by Evotec AG 46

Table 38: Insomnia – Pipeline by Grupo Ferrer Internacional SA 46

Table 39: Insomnia – Pipeline by Heptares Therapeutics Ltd 46

Table 40: Insomnia – Pipeline by Idorsia Ltd 47

Table 41: Insomnia – Pipeline by Intec Pharma Ltd 47

Table 42: Insomnia – Pipeline by Intra-Cellular Therapies Inc 48

Table 43: Insomnia – Pipeline by Johnson & Johnson 49

Table 44: Insomnia – Pipeline by Leading BioSciences Inc 49

Table 45: Insomnia – Pipeline by Merck & Co Inc 50

Table 46: Insomnia – Pipeline by Neurim Pharmaceuticals Ltd 50

Table 47: Insomnia – Pipeline by Reviva Pharmaceuticals Inc 50

Table 48: Insomnia – Pipeline by Shionogi & Co Ltd 51

Table 49: Insomnia – Pipeline by Taisho Pharmaceutical Holdings Co Ltd 51

Table 50: Insomnia – Pipeline by Yangtze River Pharmaceutical Group 52

Table 51: Restless Legs Syndrome – Dormant Projects 53

Table 52: Nocturia – Dormant Projects 53

Table 53: Insomnia – Dormant Projects 54

Table 54: Restless Legs Syndrome – Discontinued Products 56

Table 55: Insomnia – Discontinued Products 56

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Restless Legs Syndrome 8

Figure 2: Number of Products under Development by Companies Restless Legs Syndrome 9

Figure 3: Number of Products under Development for Nocturia 11

Figure 4: Number of Products under Development by Companies Nocturia 12

Figure 5: Number of Products under Development for Insomnia 14

Figure 6: Number of Products under Development by Companies Insomnia 15

Figure 7: Number of Products under Development by Universities/Institutes Insomnia 17

Figure 8: Number of Products by Targets Restless Legs Syndrome 21

Figure 9: Number of Products by Stage and Targets Restless Legs Syndrome 21

Figure 10: Number of Products by Mechanism of Actions Restless Legs Syndrome 22

Figure 11: Number of Products by Stage and Mechanism of Actions Restless Legs Syndrome 23

Figure 12: Number of Products by Routes of Administration Restless Legs Syndrome 24

Figure 13: Number of Products by Stage and Routes of Administration Restless Legs Syndrome 24

Figure 14: Number of Products by Molecule Types Restless Legs Syndrome 25

Figure 15: Number of Products by Stage and Molecule Types Restless Legs Syndrome 26

Figure 16: Number of Products by Targets Nocturia 27

Figure 17: Number of Products by Stage and Targets Nocturia 27

Figure 18: Number of Products by Mechanism of Actions Nocturia 28

Figure 19: Number of Products by Stage and Mechanism of Actions Nocturia 29

Figure 20: Number of Products by Routes of Administration Nocturia 30

Figure 21: Number of Products by Stage and Routes of Administration Nocturia 30

Figure 22: Number of Products by Molecule Types Nocturia 31

Figure 23: Number of Products by Stage and Molecule Types Nocturia 32

Figure 24: Number of Products by Top 10 Targets Insomnia 33

Figure 25: Number of Products by Stage and Top 10 Targets Insomnia 33

Figure 26: Number of Products by Top 10 Mechanism of Actions Insomnia 35

Figure 27: Number of Products by Stage and Top 10 Mechanism of Actions Insomnia 35

Figure 28: Number of Products by Routes of Administration Insomnia 37

Figure 29: Number of Products by Stage and Routes of Administration Insomnia 37

Figure 30: Number of Products by Stage and Molecule Types Insomnia 38

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