glutamine synthetase Inhibitors
2 drugsAbout glutamine synthetase
Glutamine synthetase (GS) catalyzes the ATP-dependent condensation of glutamate and ammonia to form glutamine, a vital amino acid involved in numerous biochemical processes and nitrogen metabolism.
While there is currently no genetic evidence directly linking glutamine synthetase to specific diseases, its fundamental role in cellular function makes it a compelling target.
Two FDA-approved small molecule drugs, MULTRYS and TRALEMENT, target glutamine synthetase, both approved in 2020 and marketed by AM REGENT for other indications.
Top glutamine synthetase Drugs
AM REGENT is the only company with approved drugs targeting glutamine synthetase.
Limited competition presents an opportunity, but also indicates potential challenges in the target's viability.
glutamine synthetase Drug Modality Landscape
Modalities
Routes of Administration
glutamine synthetase is druggable by small molecules, though no oral formulations are currently approved.
Explore alternative modalities like PROTACs or biologics to differentiate from existing therapies.
glutamine synthetase Clinical Trials 32 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on glutamine synthetase. 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% |
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By Modality
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glutamine synthetase Drug Approval Timeline (2020 - 2020)
The first and most recent drug approvals were in 2020, with a span of 1 year.
Recent approvals suggest renewed interest, but 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 glutamine synthetase. A trial counts if an approved drug acting on glutamine synthetase 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.