Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System Disease Article Swipe
Paul Rolan
,
Jonathan R. Seckl
,
Jack A. Taylor
,
John Harrison
,
Paul Maruff
,
Mark Woodward
,
Richard J. Mills
,
Mark Jaros
,
Dana Hilt
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/cpdd.1496
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/cpdd.1496
This review demonstrates the value of central pharmacodynamics (PD), including positron emission tomography (PET) and computerized cognitive testing, to supplement pharmacokinetic (PK) and peripheral PD for determining the target dose range for clinical efficacy testing of emestedastat, an 11β‐hydroxysteroid dehydrogenase 1 (11β‐HSD1) inhibitor. Combined data from 6 clinical trials in cognitively normal volunteers and patients with Alzheimer disease included a population PK model, endocrine PD, a human PET trial (11β‐HSD1 brain imaging), and computerized cognitive testing. PK and PET findings were similar in volunteers and patients with Alzheimer disease. PK modeling suggested that 20 mg daily would be optimal to maintain cerebrospinal fluid concentrations above the brain half maximal inhibitory concentration. However, subsequent PET scanning suggested that emestedastat doses of 10 or even 5 mg daily may be sufficient to adequately inhibit 11β‐HSD1. With once‐daily doses of 5‐20 mg in cognitively normal, older volunteers, a consistent pattern of pro‐cognitive benefit, without dose‐response, was seen as improvement in attention and working memory but not episodic memory. Thus, emestedastat therapeutic activity might be attained at doses lower than those predicted from cerebrospinal fluid drug levels. Doses as low as 5 mg daily may be efficacious and were studied in subsequent trials.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1002/cpdd.1496
- OA Status
- hybrid
- Cited By
- 1
- References
- 38
- Related Works
- 10
- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4406038945Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1002/cpdd.1496Digital Object Identifier
- Title
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Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System DiseaseWork title
- Type
-
reviewOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-01-02Full publication date if available
- Authors
-
Paul Rolan, Jonathan R. Seckl, Jack A. Taylor, John Harrison, Paul Maruff, Mark Woodward, Richard J. Mills, Mark Jaros, Dana HiltList of authors in order
- Landing page
-
https://doi.org/10.1002/cpdd.1496Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
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https://doi.org/10.1002/cpdd.1496Direct OA link when available
- Concepts
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Medicine, Pharmacodynamics, Pharmacokinetics, Standardized uptake value, Pharmacology, Positron emission tomography, Population, Cerebrospinal fluid, Cognitive decline, Clinical trial, Disease, Internal medicine, Dementia, Nuclear medicine, Environmental healthTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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38Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.concentrations | 104 |
| abstract_inverted_index.pharmacokinetic | 21 |
| abstract_inverted_index.pro‐cognitive | 149 |
| abstract_inverted_index.dose‐response, | 152 |
| abstract_inverted_index.pharmacodynamics | 8 |
| abstract_inverted_index.11β‐hydroxysteroid | 39 |
| cited_by_percentile_year.max | 95 |
| cited_by_percentile_year.min | 91 |
| corresponding_author_ids | https://openalex.org/A5040398083 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 9 |
| corresponding_institution_ids | https://openalex.org/I5681781 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.6100000143051147 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.8110943 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |