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Hypogonadism Market Spotlight 2019 - Clinical Trial Activity is Dominated by Completed Trials, and AbbVie Leads with 8 Completed Trials

DUBLIN, June 27, 2019 /PRNewswire/ -- The "Market Spotlight: Hypogonadism" report has been added to ResearchAndMarkets.com's offering.

This Market Spotlight report covers the Hypogonadism market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, key upcoming and regulatory events, probability of success, patent information, epidemiology, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • The approved drugs in the hypogonadism space target androgen receptors, estrogen receptor alpha, and estrogen receptor beta. These are commonly administered via the transdermal route, with a smaller number of products being available in intramuscular, intranasal, sublingual, oral transmucosal, subcutaneous, and topical formulations.
  • The majority of industry-sponsored drugs in active clinical development for hypogonadism are in Phase III, with only one drug in the NDA/BLA phase.
  • Therapies in mid- and late-stage development for hypogonadism focus on targets such as androgen receptors, estrogen receptor alpha, estrogen receptor beta, gonadotropin-releasing hormone, and aromatase. The majority of pipeline drugs are administered via the oral route, with the remainder being subcutaneous and transdermal formulations.
  • An estimated PDUFA date for Jatenzo's NDA is the only high-impact upcoming event in the hypogonadism space. The overall likelihood of approval of a Phase I endocrine-other asset is 34.6%, and the average probability a drug advances from Phase III is 82.1%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 8.9 years in the overall endocrine space. - There have been 16 licensing and asset acquisition deals involving hypogonadism drugs during 2014-19. The $317.5m exclusive license agreement signed in 2014 between Apricus and Forendo, for fispemifene, an investigational treatment for urological conditions in men, was the largest deal during the period.
  • The distribution of clinical trials across Phase I-IV indicates that trials for hypogonadism have been evenly split between the early and late phases of development, with 52% of trials in Phase I-II, and 48% in Phase III-IV.
  • The US has a substantial lead in the number of hypogonadism clinical trials globally. The UK leads the major EU markets, while India has the top spot in Asia.
  • Clinical trial activity in the hypogonadism space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for hypogonadism, with eight trials.
  • AbbVie leads the industry sponsors with the highest number of clinical trials for hypogonadism, followed by GlaxoSmithKline.

Key Topics Covered

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Hypogonadism subtypes

TREATMENT

  • Treatment of hypogonadism in females
  • Treatment of hypogonadism in males

EPIDEMIOLOGY

MARKETED DRUGS


PIPELINE DRUGS


RECENT EVENTS AND ANALYST OPINION

  • Tlando for Hypogonadism (May 9, 2018)
  • BGS649 for Hypogonadism (March 19, 2018)
  • Xyosted for Hypogonadism (February 21, 2018)
  • Tlando for Hypogonadism (January 10, 2018)
  • Jatenzo for Hypogonadism (January 9, 2018)
  • Tlando for Hypogonadism (January 8, 2018)
  • Jatenzo for Hypogonadism (January 5, 2018)
  • Xyosted for Hypogonadism (October 20, 2017)

KEY UPCOMING EVENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES
Figure 1: Overview of pipeline drugs for hypogonadism in the US
Figure 2: Pipeline drugs for hypogonadism, by company
Figure 3: Pipeline drugs for hypogonadism, by drug type
Figure 4: Pipeline drugs for hypogonadism, by classification
Figure 5: BGS649 for Hypogonadism (March 19, 2018): Phase IIb - MBGS205
Figure 6: Key upcoming events in hypogonadism
Figure 7: Probability of success in the hypogonadism pipeline
Figure 8: Licensing and asset acquisition deals in hypogonadism, 2014-19
Figure 9: Parent patents in hypogonadism
Figure 10: Clinical trials in hypogonadism
Figure 11: Top 10 drugs for clinical trials in hypogonadism
Figure 12: Top 10 companies for clinical trials in hypogonadism
Figure 13: Trial locations in hypogonadism
Figure 14: Hypogonadism trials status
Figure 15: Hypogonadism trials sponsors, by phase

LIST OF TABLES
Table 1: Marketed drugs for hypogonadism
Table 2: Pipeline drugs for hypogonadism in the US
Table 3: Tlando for Hypogonadism (May 9, 2018)
Table 4: BGS649 for Hypogonadism (March 19, 2018)
Table 5: Xyosted for Hypogonadism (February 21, 2018)
Table 6: Tlando for Hypogonadism (January 10, 2018)
Table 7: Jatenzo for Hypogonadism (January 9, 2018)
Table 8: Tlando for Hypogonadism (January 8, 2018)
Table 9: Jatenzo for Hypogonadism (January 5, 2018)
Table 10: Xyosted for Hypogonadism (October 20, 2017)
Table 11: Historical global sales, by drug ($m), 2013-17
Table 12: Forecasted global sales, by drug ($m), 2019-23

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