Skip to content
MedsAcross

Molecule

Prucalopride

Also known as prucalopride succinate
Available on requestGastroenterology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Prucalopride is a serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. It is available as tablets for oral use. MedsAcross supplies Prucalopride for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Serotonin-4 Receptor Agonist, Serotonin 4 Receptor Agonists
ATC classification
A06AX05 Prucalopride · Laxatives, subgroup A06A, subgroup A06AX
US FDA first approval
14 December 2018
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 0A09IUW5TPRxCUI 2107310CAS 179474-81-8DrugBank DB06480Q68484

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Source: US FDA prescribing information

How it works

Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A, 5-HT 2B, 5-HT 3, motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater. In isolated GI tissues from various animal species, prucalopride facilitated acetylcholine release to enhance the amplitude of contractions and stimulate peristalsis. In rats and dogs, prucalopride stimulated gastrointestinal motility with contractions starting from the proximal colon to the anal sphincter.

Source: US FDA prescribing information

Dosing overview

MOTEGRITY can be taken with or without food. The recommended dosage by patient population is shown in Table 1. Table 1: Recommended Dosage Regimen and Dosage Adjustments by Population Population with CIC Recommended Oral Dose Regimen Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min). 1 mg once daily Take with or without food. Recommended dosage by patient population: Population with CIC Recommended Oral Dose Regimen Adults 2 mg once daily. Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) 1 mg once daily.

Source: US FDA prescribing information

Contraindications

MOTEGRITY is contraindicated in patients with: A history of hypersensitivity to MOTEGRITY. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed. Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum. Hypersensitivity to MOTEGRITY.

Source: US FDA prescribing information

Warnings and precautions

Suicidal Ideation and Behavior: Monitor patients for suicidal ideation and behavior as well as self-injurious ideation and new-onset or worsening of depression. Instruct patients to discontinue MOTEGRITY immediately and contact their healthcare provider if they experience any unusual changes in mood or behavior, or they experience emerging suicidal thoughts or behaviors.

Source: US FDA prescribing information

Side effects

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

Source: US FDA prescribing information

Storage

Store MOTEGRITY at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Store MOTEGRITY in the original container to protect from moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Prucalopride, sorted by availability.

MedicineManufacturerRegisterAvailability
Prucalopride 1 mg tabletOralGeneric name—US FDAAvailable on request
Prucalopride 2 mg tabletOralGeneric name—US FDAAvailable on request
Motegrity 1 mg tabletOralTakeda PharmaceuticalsUS FDAAvailable on request
Motegrity 2 mg tabletOralTakeda PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 December 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Prucalopride available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Prucalopride and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Prucalopride have?

The catalogue lists 1 brand names for Prucalopride, including Motegrity.

Is Prucalopride approved by the US FDA?

Yes. The US FDA first approved Prucalopride on 14 December 2018, according to Drugs@FDA.

Is Prucalopride authorised in the European Union?

Yes. Prucalopride has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Prucalopride need cold chain shipping?

No listed presentation of Prucalopride is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Prucalopride in?

Prucalopride is classified under ATC code A06AX05 (Prucalopride).

References

  1. MOTEGRITY prescribing information (Takeda Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 17 July 2025
  2. Resolor: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 September 2024

Request Prucalopride for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.