Motegrity

Treats chronic idiopathic constipation (CIC). NDA 210166, held by Takeda Pharms USA. Prucalopride Succinate.

As of Nov 14, 2026, NDA 210166 (Motegrity), held by Takeda Pharms USA, was first approved by FDA on Dec 14, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MOTEGRITY is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Jul 10, 2025	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


MotegrityEQ 1MG BASE · tablet;oral	Prucalopride Succinate	RxReference drug
MotegrityEQ 2MG BASE · tablet;oral	Prucalopride Succinate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2020	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 14, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 210166
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters