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Last update 23 May 2026
ASP-9831
Last update 23 May 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms ASP 9831, ASP9831 |
Target |
Action inhibitors |
Mechanism PDE4 inhibitors(Phosphodieterase 4 inhibitors) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
License Organization- |
Drug Highest PhasePendingPhase 2 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Molecular FormulaC20H23N3O3 |
InChIKeyUECHVFIKTBUKTP-UHFFFAOYSA-N |
CAS Registry728013-50-1 |
Related
1
Clinical Trials associated with ASP-9831NCT00668070
Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)
100 Clinical Results associated with ASP-9831
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100 Translational Medicine associated with ASP-9831
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100 Patents (Medical) associated with ASP-9831
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2
Literatures (Medical) associated with ASP-983101 Oct 2014Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological AssociationQ1 · MEDICINE
Serum Alanine Aminotransferase as a Biomarker of Treatment Response in Nonalcoholic Steatohepatitis
Q1 · MEDICINE
Communications
Author: Loomba, Rohit
Ratziu et al report a phase I as well as aphase II randomized controlled clin. trial that aimed to examine the safety and efficacy of a phosphodiesterase-4 inhibitor, ASP9831, for the treatment of NASH.Theauthors reported that there was no significant differencein serum ALT level between the baseline and the week-12 value between the treatment arm and the placebo arm, and concluded that ASP9831, although safe in a 12-wk study, did not improve liver disease in patients with biopsy-proven NASH.It is reasonable to assume nonresponse to an agent if there is no significant decrease in serum ALT level in a NASH treatment trial.However, biomarkers that are more accurate and precise, and biol. informative, are emerging and may be used along with serum ALT level in future trials.
01 Oct 2014Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological AssociationQ1 · MEDICINE
Lack of Efficacy of an Inhibitor of PDE4 in Phase 1 and 2 Trials of Patients With Nonalcoholic Steatohepatitis
Q1 · MEDICINE
Article
Author: Lawrence Serfaty ; Victor De Lédinghen ; Mihai Voiculescu ; Pierre Bedossa ; Sven M. Francque ; Frederik Nevens ; Jun Takeda ; Guruprasad P. Aithal ; Stephen D. Ryder ; Pavel Trunecka ; Christopher P. Day ; Vlad Ratziu ; Dominique Larrey ; Gabriele I. Kirchner ; Liliana Preotescu ; Klaudia Traudtner
BACKGROUND & AIMS:
ASP9831 is a phosphodiesterase-4 inhibitor developed to treat nonalcoholic steatohepatitis (NASH); it showed potent anti-inflammatory and antifibrotic effects in preclinical studies. We evaluated the efficacy and safety of ASP9831 in patients with NASH.
METHODS:
In a phase 1 trial, we determined the optimal therapeutic window of ASP9831 in healthy volunteers and evaluated 2 doses (50 and 100 mg) in patients with NASH. Based on the positive outcomes of the phase 1 study, we performed a phase 2 trial to compare the biochemical effects of ASP9831 vs placebo. Patients with NASH were assigned randomly to groups given either 50 mg (n = 33) or 100 mg (n = 33) ASP9831 twice daily, or placebo (n = 30), for 12 weeks. The primary end point was the mean percentage change, from baseline to the end of ASP9831 administration, in serum level of alanine aminotransferase (ALT); secondary outcomes included changes in aspartate aminotransferase (AST) levels, ratio of AST:ALT, and various biomarkers of NASH.
RESULTS:
After 12 weeks of administration, there was no significant change in mean serum levels of ALT (P = .42) or AST (P = .20) or other biomarkers in any group, and no significant differences were observed among groups. Most adverse events were mild; gastrointestinal disorders occurred more frequently in the ASP9831 groups than the placebo group.
CONCLUSIONS:
Despite a relevant mechanism of action, ASP9831 did not significantly alter the biochemical markers of NASH, compared with placebo, in a clinical trial. This highlights the difficulties of developing therapeutics for NASH and the need for more extensive preclinical testing of mechanisms of potential drug candidates. Clinicaltrialsregister.eu: 2005-001687-31; EudraCT numbers: 2007-002114-19.
100 Deals associated with ASP-9831
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | Belgium | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | Czechia | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | France | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | Germany | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | Romania | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | Switzerland | 01 Apr 2008 | |
| Metabolic Dysfunction Associated Steatohepatitis | Phase 2 | United Kingdom | 01 Apr 2008 |
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