DHODH Inhibitors
4 drugsAbout DHODH
Dihydroorotate dehydrogenase (DHODH) is an enzyme essential for de novo pyrimidine biosynthesis, a metabolic pathway critical for cell growth and proliferation. It catalyzes the fourth step in pyrimidine synthesis, providing precursors for DNA and RNA synthesis.
DHODH is a compelling drug target because rapidly dividing cells, like those in autoimmune diseases, require high levels of pyrimidines. Inhibiting DHODH reduces the production of these essential building blocks, potentially slowing disease progression. There is currently no genetic evidence directly linking DHODH to specific diseases.
DHODH is targeted by two FDA-approved small molecule drugs: ARAVA (leflunomide) and LEFLUNOMIDE. These drugs are used in immunology and other therapeutic areas. Sanofi and HERITAGE are the companies marketing these drugs.
Top DHODH Drugs
The competitive landscape includes two companies, HERITAGE and Sanofi, with approved DHODH-targeting drugs.
Low market concentration suggests opportunities for new entrants, but established players pose a competitive threat.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| LEFLUNOMIDE | Lupin | 2005 | 1 |
DHODH Drug Modality Landscape
Modalities
Routes of Administration
DHODH is amenable to small molecule drugs, with oral options available for convenient dosing.
Explore alternative modalities like antibodies or PROTACs to differentiate from existing therapies.
DHODH Clinical Trials 83 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on DHODH. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 16 | 6 | 3 | 7 | 67% |
| Phase 2 | 16 | 4 | 4 | 8 | 50% |
| Phase 3 | 34 | 22 | 5 | 7 | 81% |
| Phase 4 | 17 | 14 | 1 | 2 | 93% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
3 Phase 3 trials testing approved DHODH drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting DHODH. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
DHODH Drug Approval Timeline (1998 - 2018)
The first DHODH inhibitor, ARAVA, was approved in 1998, and the most recent, LEFLUNOMIDE, in 2005.
The limited approval span indicates potential saturation; new DHODH inhibitors may face challenges gaining market share.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 3 companies competing
- • Market share by company
Full Drug Portfolio
- • All 4 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 4-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 42 (11 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 DHODH. A trial counts if an approved drug acting on DHODH 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.