Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MMX Mesalamine · 2 trials · 1 indication
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Clinical response was defined as partial UC-DAI \<=1 with (rectal bleeding = 0, stool frequency \< or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Clearance of a substance from the blood by the kidneys.
| Arm | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine (30mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (60 mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (100 mg/kg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine | DRUG | 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
Inclusion Criteria: 1. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative \[LAR\]) informed consent or assent as applicable to participate in the study. 2. Subject's parent/LAR demonstrates an understanding, ability, and willingness to f...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
MMX Mesalamine is used for ulcerative colitis, a chronic inflammatory bowel disease. It is being studied in pediatric patients with mild to moderate ulcerative colitis. The drug is a small molecule developed by Takeda Pharmaceutical Company Limited and is currently in clinical development, with Phase 3 trials completed.
MMX Mesalamine is a small molecule that works by delivering mesalamine, an anti-inflammatory agent, directly to the colon. It uses a multi-matrix (MMX) technology to release the drug throughout the colon, reducing inflammation in the intestinal lining. This mechanism helps treat ulcerative colitis by targeting the inflamed tissue.
MMX Mesalamine is developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is responsible for the research, clinical development, and potential commercialization of this drug for ulcerative colitis. The company's ticker symbol is TAK.
MMX Mesalamine is in Phase 3 clinical development for ulcerative colitis. It has completed two clinical trials, including a Phase 3 efficacy and safety study in pediatric patients. The drug is investigational and has not been approved by regulatory authorities, as it remains under clinical evaluation.
MMX Mesalamine has been studied in two completed clinical trials. NCT01130844 was a Phase 1 safety and pharmacokinetics study in children and adolescents with ulcerative colitis, enrolling 52 participants. NCT02093663 was a Phase 3 safety and efficacy study in pediatric patients with mild to moderate ulcerative colitis, enrolling 107 participants.
MMX Mesalamine is a formulation of mesalamine, also known as mesalazine. The MMX technology is a specific delivery system that releases mesalamine throughout the colon. While the active ingredient is the same, MMX Mesalamine refers to this particular extended-release formulation developed by Takeda.