Table 1.
Main industry-sponsored studies for oral NME currently in development for multiple sclerosis
| Name | Development Phase | Clinicaltrials.gov identifier | Company | Route | Mechanism | Comparator | MS type |
| Cladribine | Phase 3 completed (CLARITY) | NCT00213135 | Merck-Serono | p.o. | Purine analogue | Placebo IFNb1a s.c. (rescue) | RMS |
| Phase 3 ongoing (ORACLE) | NCT00725985 | Merck-Serono | p.o. | Purine analogue | Placebo | CIS | |
| Fingolimod | Phase 3 completed (FREEDOMS I & II, TRANSFORMS) | NCT00340834 | Novartis | p.o. | Sphingosine 1 phosphate agonist | Placebo | RMS |
| NCT00289978 | Placebo | ||||||
| NCT00355134 | IFNb1a i.m. | ||||||
| Phase 3 ongoing (INFORM) | NCT00731692 | Novartis | p.o. | Sphingosine 1 phosphate agonist | Placebo | PPMS | |
| Teriflunomide | Phase 3 ongoing (TOWER, TEMSO, TENERE) | NCT00751881 | Sanofi-Aventis | p.o. | Dihydroorotate dehydrogenase inhibitor | Placebo | RMS |
| NCT00134563 | Placebo | ||||||
| NCT00883337 | IFNb1a s.c. | ||||||
| Phase 3 ongoing (TOPIC) | NCT00622700 | Sanofi-Aventis | p.o. | Dihydroorotate dehydrogenase inhibitor | Placebo | CIS | |
| Laquinimod | Phase 3 ongoing (ALLEGRO & BRAVO) | NCT00509145 | Teva/Active Biotech | p.o. | Dihydro-quinoline derivative | Placebo | RMS |
| NCT00605215 | Placebo & IFNb1a i.m. | ||||||
| Dimethylfumarate (BG-12) | Phase 2 POC completed, ongoing (EXPLORE) Phase 3 starting (DEFINE, CONFIRM) | NCT00168701 | Biogen Idec | p.o. | Second generation fumaric acid derivative Nrf2 pathway activator | Placebo | RMS |
| NCT01156311 | Add-on to IFN and GA | ||||||
| NCT00420212 | Placebo | ||||||
| NCT00451451 | Placebo & GA | ||||||
| BAF312 | Phase 2 ongoing | NCT00879658 | Novartis | p.o. | Sphingosine 1 phosphate agonist | Placebo | RMS |
| ACT-128800 | Phase 2 ongoing | NCT01006265 | Actelion | p.o. | Sphingosine 1 phosphate agonist | Placebo | RMS |
| CDP 323 | Phase 2 terminated | NCT00484536 | Biogen Idec UCB | p.o. | Integrin alpha4 antagonist | Placebo | RMS |
| Firategrast | Phase 2 completed (no POC study) | NCT00469378 | GSK | p.o. | Integrin alpha4 antagonist | N/A | RMS |
CIS, clinical isolated syndrome; GA, glatiramer acetate; IFN, interferon; i.m., intramuscular; MS, multiple sclerosis; p.o., per os; POC, proof-of-concept; PPMS, primary progressive MS; RMS, relapsing MS; s.c., subcutaneous.