Asset profile
afimkibart
Monoclonal antibody
Evidence outlook · registrational
Ulcerative Colitis: registrational readout pending
Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2026-10-29.
NCT04090411: This was a randomized, double-blind, placebo-controlled Phase 2 study (N=246) in moderate-to-severe ulcerative colitis, with Week 14 clinical remission on the Mayo score as the primary endpoint. Although remission rates were numerically higher in all afimkibart dose groups (25.5%, 23.3%, 23.9%) than placebo (11.6%), the differences were not statistically significant (one-sided p-values 0.055–0.082; 90% confidence intervals crossed zero), so the primary efficacy comparison was not met. The well-controlled design is real evidence, but because the primary endpoint was missed, the trial does not rise to strong evidence of benefit.
Also in development:Atopic Dermatitis · Phase 2Crohn's Disease · Phase 3
How the evidence outlook works ↗
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
151 competitors in this universe: 7 direct rivals (same mechanism and indication), 1 same-class, 143 same-indication; 70 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Afimkibart: this drug | Phase 3 | Monoclonal antibody | TL1A | ||
| Duvakitug | Phase 3 | Monoclonal antibody | TL1A | ||
| Tulisokibart | Phase 3 | Monoclonal antibody | TL1A | ||
| MT-201 | Phase 2 | Multispecific antibody | TL1A, IL-23 p19 | ||
| SPY002 | Phase 2 | Monoclonal antibody | TL1A | ||
| SSGJ-627 | Phase 2 | Biologic (subtype unspecified) | TL1A | ||
| XmAb942 | Phase 1/2 | Monoclonal antibody | TL1A | ||
| TL-003 | Phase 1 | Multispecific antibody | TL1A, IL-23 p19 | ||
| SPY072 | Phase 2 | — | TL1A | ||
| Abrocitinib (Cibinqo) | Approved | Small molecule | JAK1 | ||
| 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 |
…and 136 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
1 further head-to-head pair is tracked; the rosters on each shared mechanism and indication page list every rival in the race.
Upcoming events
(12 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (2)
2027 (3)
January 2027 (1)
What to watch
April 2027 (1)
What to watch
July 2027 (1)
What to watch
2028 (3)
May 2028 (1)
What to watch
2030 (2)
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.