Asset profile
obefazimod
Small molecule
Evidence outlook · lead readout
ABTECT - Maintenance (NCT05535946) · Ulcerative Colitis
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
ABTECT - Maintenance (NCT05535946): This trial randomized responder patients to obefazimod 25 mg, 50 mg, or placebo under triple-blind conditions, with a large sample size (over 1,100 participants enrolled across the program), and its primary endpoint was clinical remission, a hard, disease-defining measure of ulcerative colitis activity. The comparison clearly favored obefazimod over placebo with a large effect size and high statistical significance, meeting all the elements needed for strong evidence: real randomization, blinding, an adequately sized placebo control, a hard clinical endpoint, and a statistically significant favorable result.
Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.
Also in development:Crohn's Disease · Phase 2
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
83 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 83 same-indication; 59 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Obefazimod: this drug | Phase 3 | Small molecule | miR-124 | ||
| Adalimumab (Humira) | Approved | Monoclonal antibody | TNF-alpha | ||
| Adalimumab-Aacf (Idacio) | Approved | — | TNF-alpha | ||
| Adalimumab-Aaty (Yuflyma) | Approved | — | TNF-alpha | ||
| Adalimumab-Adaz (Hyrimoz) | Approved | — | TNF-alpha | ||
| Adalimumab-Adbm (Cyltezo) | Approved | Monoclonal antibody | TNF-alpha | ||
| Adalimumab-Afzb (Abrilada) | Approved | — | TNF-alpha | ||
| Adalimumab-Aqvh (Yusimry) | Approved | — | TNF-alpha | ||
| Adalimumab-Atto (Amjevita) | Approved | — | TNF-alpha | ||
| Adalimumab-Bwwd (Hadlima) | Approved | — | TNF-alpha | ||
| Adalimumab-Fkjp (Hulio) | Approved | — | TNF-alpha | ||
| Adalimumab-Ryvk (Simlandi) | Approved | — | TNF-alpha | ||
| Balsalazide Disodium (Colazal) | Approved | — | Aminosalicylate | ||
| Balsalazide Disodium (Giazo) | Approved | — | Aminosalicylate | ||
| Budesonide (Entocort EC) | Approved | — | Glucocorticoid receptor | ||
| Budesonide (Ortikos) | Approved | — | Glucocorticoid receptor |
…and 68 more. Research shows the complete landscape.
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Upcoming events
(2 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.