Approval Probability
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Also known as HMPL-004 low dose, Chuan xinlian
HMPL-004 · 2 trials · 2 indications
Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.
Percentage of subjects with CDAI clinical response -100 at Week 8 based on ITT population using the WOCF method to impute missing CDAI scores at Week 8. Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8. The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | Matching dose of placebo will be given orally in capsules three times per day for 56 days. |
| HMPL-004 low dose | EXPERIMENTAL | A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| HMPL-004 high dose | EXPERIMENTAL | A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| HMPL-004 | EXPERIMENTAL | Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up. |
| Name | Type | Description |
|---|---|---|
| HMPL-004 low dose | DRUG | HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| Placebo | DRUG | Matching dose of Placebo |
| HMPL-004 high dose | DRUG | HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day). |
| HMPL-004 | DRUG | HMPL-004 1200 mg/d |
Inclusion Criteria: * Have active confirmed mild to moderate ulcerative colitis Exclusion Criteria: * Diagnosed with Crohn's Disease or
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 |
HMPL-004 is an investigational small molecule being studied for inflammatory bowel disease, specifically Crohn's Disease and Ulcerative Colitis. It is being developed by HUTCHMED (China) Limited. The drug has completed Phase 2 clinical trials in both conditions, but it is not approved for any indication.
HMPL-004 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is advancing the drug as a small molecule candidate for gastrointestinal indications including Crohn's Disease and Ulcerative Colitis.
HMPL-004 is in Phase 2 development. It has completed Phase 2 clinical trials in Crohn's Disease and Ulcerative Colitis. The drug is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
HMPL-004 has been evaluated in two completed Phase 2 trials. NCT00659802 studied HMPL-004 in 224 patients with Ulcerative Colitis, and NCT00655733 studied it in 101 patients with Crohn's Disease. Both trials were randomized, double-blind, and placebo-controlled, enrolling adults aged 18 and older.
Yes, HMPL-004 low dose is an alternative name for HMPL-004. Both names refer to the same investigational small molecule developed by HUTCHMED (China) Limited for Crohn's Disease and Ulcerative Colitis. The low dose designation distinguishes a specific dosing regimen studied in clinical trials.