Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D9421-C · 2 trials · 1 indication
For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.
Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.
| Arm | Type | Description |
|---|---|---|
| D9421-C | EXPERIMENTAL | D9421-C 9 mg once daily |
| Mesalazine | ACTIVE_COMPARATOR | Mesalazine 1 g three times a day |
| 1 | ACTIVE_COMPARATOR | D9421-C 9 mg |
| 2 | ACTIVE_COMPARATOR | D9421-C 15 mg |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| D9421-C capsule 3 mg | DRUG | Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. |
| Mesalazine tablets | DRUG | Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. |
| D9421-C, 9mg | DRUG | D9421-C 9 mg was given once daily for 8 weeks. |
| D9421-C, 15mg | DRUG | D9421-C 15 mg was given once daily for 8 weeks. |
| Placebo | DRUG | D9421-C matching placebo was given once daily for 8 weeks. |
Inclusion Criteria: * 15 years of age or older * Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation ...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
D9421-C is an investigational small molecule developed by AstraZeneca PLC for the treatment of Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract. It is being studied in clinical trials and is not described as approved. The program includes two completed studies conducted in Japan.
D9421-C is being developed for the treatment of active Crohn's disease, a gastrointestinal inflammatory condition. Both completed clinical trials enrolled patients with active Crohn's disease in Japan, one at 9 mg and one comparing 9 mg and 15 mg against placebo. It remains an investigational therapy rather than an established treatment option.
D9421-C is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored both clinical studies of the drug in patients with active Crohn's disease in Japan, including a Phase 3 trial and an earlier Phase 2 trial.
D9421-C has reached Phase 3 development. A Phase 3 study of the 9 mg dose in patients with active Crohn's disease in Japan has been completed, following an earlier completed Phase 2 trial. The drug is investigational and is not described as approved.
Two completed trials have studied D9421-C in Crohn's disease. NCT01514240 was a Phase 3 study of the 9 mg dose in Japanese patients with active Crohn's disease, enrolling 123 participants. NCT00573469 was a Phase 2 study comparing 9 mg and 15 mg doses with placebo in 75 Japanese patients.