Approval Probability
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Label indication LIALDA ® is indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. LIALDA is an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. FDA label
Also known as SPD476 (1.2g), SPD476 (mesalazine), Lialda, mesalazine, mesalamine, MMX mesalamine
SPD476 · 7 trials · 4 indications
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.
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\].
A taste assessment was completed immediately after investigational product was administered to assess the subject's taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is 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. |
| SPD476 (1.2 g) | EXPERIMENTAL | - |
| SPD476 (2.4 g) | EXPERIMENTAL | - |
| SPD476 (4.8 g) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SPD476 | EXPERIMENTAL | Mesalazine |
| Asacol | ACTIVE_COMPARATOR | - |
| Mesalamine (Vanilla Yogurt) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt |
| Mesalamine (Applesauce) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce |
| Mesalamine (Dosing Cup) | EXPERIMENTAL | One 500mg capsule contents emptied into a dosing cup and taken with water |
| 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. |
| SPD476, MMX™ mesalazine, 1.2g extended release tablet | DRUG | SPD476 1.2g administered Once Daily (QD) |
| SPD476, MMX™ mesalazine, 2.4g extended release tablet | DRUG | SPD476 2.4g administered Once Daily (QD) |
| SPD476, MMX™ mesalazine, 4.8g extended release tablet | DRUG | SPD476 4.8g administered Once Daily (QD) |
| Placebo | DRUG | Placebo administered Once Daily (QD) |
| SPD476 (1.2g) | DRUG | 1.2g SPD476 once daily (QD) orally |
| SPD476 (2.4 g) | DRUG | 2.4g SPD476 QD orally |
| SPD476 (4.8 g) | DRUG | 4.8g SPD476 QD orally |
| SPD476 | DRUG | 2.4 g/day Once Daily (QD) |
| Asacol | DRUG | 1.6g/day administered 800 mg Twice Daily (BID) |
| SPD476 (mesalazine) | DRUG | - |
| Mesalamine | DRUG | - |
| 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...
SPD476 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited (ticker TAK). It is a 1.2g extended release tablet formulation studied in Phase 3 clinical trials for diverticulitis and ulcerative colitis, two gastrointestinal conditions. SPD476 has been evaluated in completed Phase 3 trials but is not described as approved.
SPD476 has been studied for two gastrointestinal indications: prevention of recurrence of diverticulitis and maintenance of remission in patients with ulcerative colitis. Both uses were evaluated in Phase 3 clinical trials that have completed. SPD476 is an investigational therapy and is not described as approved for any indication.
SPD476 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 3 clinical program evaluating SPD476 in diverticulitis and ulcerative colitis. The drug is also known as MMX mesalazine and as a 1.2g extended release tablet.
SPD476 is in Phase 3 clinical development. Four Phase 3 trials have been completed, two in diverticulitis and two in ulcerative colitis, with no active trials currently listed. SPD476 is investigational and is not described as FDA approved.
SPD476 has been studied in completed Phase 3 trials including NCT00545740 and NCT00545103, both titled Prevention of Recurrence of Diverticulitis, and NCT00151944 and NCT00151892, which evaluated maintenance of remission in ulcerative colitis. These trials enrolled adults aged 18 years and older across multiple countries.
Yes, SPD476 is also known as MMX mesalazine and as a 1.2g extended release tablet. These names refer to the same investigational product developed by Takeda Pharmaceutical Company Limited. Readers searching for MMX mesalazine or SPD476 1.2g are looking at the same asset.