Folylpolyglutamate Synthetase Inhibitors
6 drugsAbout Folylpolyglutamate Synthetase
Folylpolyglutamate Synthetase (FPGS) is an enzyme essential for folate metabolism. It catalyzes the ATP-dependent addition of glutamate residues to folate, creating polyglutamated forms that act as cofactors for nucleotide biosynthesis and amino acid metabolism.
FPGS is a therapeutic target in oncology because of its role in rapidly dividing cells. However, there is currently no genetic evidence directly linking variations in the FPGS gene to specific disease risks.
FPGS is targeted by 6 FDA-approved small molecule drugs, including PEMETREXED (ALIMTA), PEMFEXY, and AXTLE, all for oncology indications. These drugs are developed by companies such as Eli Lilly, Eagle Pharms, and Qilu Pharm Hainan.
Top Folylpolyglutamate Synthetase Drugs
Six companies have approved drugs targeting FPGS, including Qilu Pharm Hainan and Eli Lilly.
The presence of multiple players suggests moderate competition, but also established market demand.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| PEMETREXED DISODIUM | Apotex | 2022 | 2 |
| PEMETREXED | SHILPA | 2020 | 2 |
| PEMETREXED FOR INJECTION | Dr. Reddy's | - | - |
Folylpolyglutamate Synthetase Drug Modality Landscape
Modalities
Routes of Administration
Folylpolyglutamate Synthetase is druggable by small molecules, though no oral formulations are currently approved.
Exploring alternative modalities like antibodies or PROTACs could provide differentiation in this space.
Folylpolyglutamate Synthetase Clinical Trials 758 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Folylpolyglutamate Synthetase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 208 | 83 | 41 | 83 | 67% |
| Phase 2 | 344 | 103 | 81 | 158 | 56% |
| Phase 3 | 193 | 63 | 28 | 102 | 69% |
| Phase 4 | 13 | 6 | 3 | 4 | 67% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
8 Phase 3 trials testing approved Folylpolyglutamate Synthetase drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting Folylpolyglutamate Synthetase. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Folylpolyglutamate Synthetase Drug Approval Timeline (2004 - 2024)
The first drug targeting FPGS was approved in 2004 (ALIMTA), with the most recent approval in 2024 (AXTLE).
Continued approvals suggest ongoing interest, but a 21-year span indicates potential market saturation.
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Competitive Landscape
- • 6 companies competing
- • Market share by company
Full Drug Portfolio
- • All 6 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 6-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 319 (141 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 Folylpolyglutamate Synthetase. A trial counts if an approved drug acting on Folylpolyglutamate 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.