Folylpolyglutamyl synthetase Inhibitors
1 drugsAbout Folylpolyglutamyl synthetase
Folylpolyglutamate synthetase (FPGS) is an enzyme essential for folate metabolism, catalyzing the polyglutamylation of folates, which are crucial for DNA synthesis and repair. Polyglutamylated folates are retained within cells and represent the primary functional form of vitamin B9.
Targeting FPGS disrupts folate-dependent pathways, impacting rapidly dividing cells; however, there is currently no genetic evidence directly linking FPGS to specific diseases. The only approved drug, Pralatrexate (FOLOTYN), modulates folate metabolism.
FPGS is targeted by one FDA-approved small molecule drug, FOLOTYN, developed by ACROTECH BIOPHARMA. FOLOTYN was first approved in 2009 and is used in "other" therapeutic areas.
Top Folylpolyglutamyl synthetase Drugs
ACROTECH BIOPHARMA is the only company with an approved drug targeting FPGS.
Low competition suggests an opportunity for new entrants, but also indicates potential market risk.
Folylpolyglutamyl synthetase Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Folylpolyglutamyl synthetase, using small molecule modality.
Explore alternative modalities like PROTACs or biologics to differentiate from existing therapies.
Folylpolyglutamyl synthetase Clinical Trials 33 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Folylpolyglutamyl synthetase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 16 | 7 | 3 | 6 | 70% |
| Phase 2 | 11 | 10 | 0 | 1 | 100% |
| Phase 3 | 6 | 2 | 2 | 2 | 50% |
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By Modality
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Top Drugs
Phase 3 Readout Calendar Pro
1 Phase 3 trial testing approved Folylpolyglutamyl synthetase drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting Folylpolyglutamyl synthetase. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Folylpolyglutamyl synthetase Drug Approval Timeline (2009 - 2009)
The first and only drug targeting FPGS, FOLOTYN, was approved in 2009.
The lack of recent approvals indicates a potentially saturated market or challenges in developing new FPGS-targeting drugs.
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Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 1 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 1-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 18 (7 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 Folylpolyglutamyl synthetase. A trial counts if an approved drug acting on Folylpolyglutamyl 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.