arginase Inhibitors
2 drugsAbout arginase
Arginase is an enzyme that catalyzes the hydrolysis of arginine into ornithine and urea. It plays a role in the urea cycle, nitric oxide production, and polyamine synthesis.
Arginase has emerged as a drug target due to its involvement in various biological processes. Currently, there is no genetic evidence directly linking arginase to specific diseases.
There are two FDA-approved small molecule drugs targeting arginase: MULTRYS and TRALEMENT. Both drugs are marketed by AM REGENT and are approved for 'other' therapeutic areas.
Top arginase Drugs
AM REGENT is the only company with approved arginase-targeting drugs.
The market is highly concentrated, suggesting high barriers to entry or limited commercial opportunity.
arginase Drug Modality Landscape
Modalities
Routes of Administration
arginase is druggable by small molecules, though no oral formulations are currently approved.
The lack of diverse modalities represents a whitespace opportunity for novel therapeutic approaches.
arginase Clinical Trials 32 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on arginase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 | 100% |
| Phase 2 | 10 | 8 | 0 | 2 | 100% |
| Phase 3 | 8 | 6 | 0 | 2 | 100% |
| Phase 4 | 11 | 8 | 2 | 1 | 80% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
arginase Drug Approval Timeline (2020 - 2020)
The first arginase-targeting drug was approved in 2020, with the most recent approval also in 2020.
The recent approvals suggest renewed interest, but the lack of subsequent approvals may indicate market saturation.
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Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 27 (2 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on arginase. A trial counts if an approved drug acting on arginase is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.