guanylate cyclase-C agonist
Plecanatide dose
Answer
FDA label for Trulance Immediate release: The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily. 2.2 Preparation and Administration Instructions Take TRULANCE with or without food [see Clinical Pharmacology ]. If a dose is missed, skip the missed dose and take the next dose at the regular time. Trials with posted results tested 8 doses, most often 6 mg, 3 mg, 1 mg.
Not dosing advice.
FDA LABEL
What the approved labels state
Trulance Immediate release NDA208745 · label of 2024-04-04 Regulator
The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily. 2.2 Preparation and Administration Instructions Take TRULANCE with or without food [see Clinical Pharmacology ]. If a dose is missed, skip the missed dose and take the next dose at the regular time.
IN TRIALS
Doses tested in 11 trials with posted results
| Dose in the arm title | Trials | People on it | Phases |
|---|---|---|---|
| 6 mg | 5 | 3,798 | 3 |
| 3 mg | 8 | 2,246 | 2/3 |
| 1 mg | 4 | 416 | 2/3 |
| 0.3 mg | 2 | 322 | 2/3 |
| 9 mg | 1 | 85 | 2 |
| 0.5 mg | 2 | 61 | 2 |
| 1.5 mg | 1 | 32 | 2 |
| 2 mg | 1 | 32 | 2 |
Trial register Read from the titles of arms that received Plecanatide (n ≥ 20). An arm naming several doses counts under each; a schedule or escalation is on the trial record. All trials.
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