Wednesday, July 8, 2026

Drug profile · INN

linaclotide

linaclotide (CONSTELLA) is a heat-stable enterotoxin receptor agonist. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Alimentary tract and metabolism (A06) A06AX04
US status approved
Patents linked 20
Pipeline programs 15
News articles 0
Drug details — linaclotide
US status
approved
Class
Alimentary tract and metabolism (A06)
Route
ORAL
Patents
20
Programs
15
Data quality
0.84

Quick answer

linaclotide (CONSTELLA) is a heat-stable enterotoxin receptor agonist. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN linaclotide
Brand CONSTELLA
Mechanism Heat-stable enterotoxin receptor agonist
Target Guanylyl cyclase C
Therapeutic class Alimentary tract and metabolism (A06)
Route ORAL
Formulation CAPSULE
ATC code A06AX04

Mechanism of action

Heat-stable enterotoxin receptor agonist

Primary target: Guanylyl cyclase C

Approval history

Authority Status Date
FDA approved
EMA approved
NMPA clinical trials

Pipeline programs

  1. Linaclotide Phase 3 · IRONWOOD PHARMACEUTICALS · Chronic Idiopathic Constipation
  2. Linaclotide Phase 3 · IRONWOOD PHARMACEUTICALS · Functional Constipation
  3. Linaclotide Phase 3 · IRONWOOD PHARMACEUTICALS · Chronic Constipation
  4. Linaclotide 290 micrograms Phase 3 · IRONWOOD PHARMACEUTICALS · Irritable Bowel Syndrome Characterized by Constipation
  5. Linaclotide 290 micrograms Phase 3 · IRONWOOD PHARMACEUTICALS · Chronic Constipation
  6. Linaclotide or Matching Placebo Phase 3 · IRONWOOD PHARMACEUTICALS · Irritable Bowel Syndrome With Constipation
  7. Placebo for Linaclotide Phase 3 · IRONWOOD PHARMACEUTICALS · Functional Constipation (FC)
  8. linaclotide Phase 3 · Astellas Pharma · Chronic Constipation

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Related patents

  1. WO 2026100645

    MÉTHODES DE TRAITEMENT DES SYMPTÔMES VASOMOTEURS CHEZ DES PATIENTES ATTEINTES DE CANCER DU SEIN AVEC LE FÉZOLINÉTANT

    Expires Thu May 10 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2026033885

    POLYTHÉRAPIE FAISANT INTERVENIR DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

    Expires Wed Feb 07 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2025207099

    INHIBITEURS DE PPAR-DELTA POUR PRÉVENIR UNE FIBRILLATION AURICULAIRE POST-OPÉRATOIRE

    Expires Wed Sep 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. AR 133027

    COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UN COMPUESTO DE QUINAZOLINA

    Expires Tue Aug 15 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. WO 2025159142

    COMPOSÉ HÉTÉROCYCLIQUE POUR INDUIRE LA DÉGRADATION DE LA PROTÉINE KRAS

    Expires Wed Jul 26 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. WO 2025143118

    COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT D'UNE LÉSION DE LA MOELLE ÉPINIÈRE ET PROCÉDÉ DE PRODUCTION D'UN MODÈLE ANIMAL DE PRIMATE NON HUMAIN POUR UNE LÉSION DE LA MOELLE ÉPINIÈRE

    Expires Wed Jun 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. WO 2025121445

    POLYTHÉRAPIE IMPLIQUANT DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

    Expires Wed Jun 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. WO 2025120866

    POLYTHÉRAPIE IMPLIQUANT DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

    Expires Wed Jun 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. WO 2025047847

    VARIANT DE RÉGION Fc

    Expires Wed Mar 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. WO 2025018295

    BACTÉRIOPHAGE MODIFIÉ

    Expires Wed Jan 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. WO 2024261256

    COMPOSITION PHARMACEUTIQUE COMPRENANT UN AGENT DE DÉGRADATION PAN-KRAS

    Expires Wed Dec 21 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. WO 2024219427

    PROCÉDÉ DE PRODUCTION DE LYMPHOCYTES INNÉS DE TYPE 2

    Expires Wed Oct 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. WO 2024162304

    LIPIDE CARBAMOYLE OU LIPIDE D'URÉE AYANT CHACUN UNE AMINE CYCLIQUE, NANOPARTICULES LIPIDIQUES LE CONTENANT ET COMPOSITION PHARMACEUTIQUE

    Expires Wed Aug 03 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. WO 2024141977

    CELLULES TUEUSES NATURELLES MODIFIÉES ET PROCÉDÉS ASSOCIÉS

    Expires Wed Jun 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10702576

    Stable formulations of linaclotide

    Expires Mon Jul 02 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10675325

    Stable formulations of linaclotide

    Expires Mon Jun 04 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9708371

    Treatments for gastrointestinal disorders

    Expires Mon Jul 13 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 8933030

    Treatments for gastrointestinal disorders

    Expires Mon Jan 08 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 8802628

    Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

    Expires Mon Aug 07 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 8748573

    Formulations comprising linaclotide

    Expires Mon Jun 05 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is linaclotide?

linaclotide (CONSTELLA) is a heat-stable enterotoxin receptor agonist. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for linaclotide?

CONSTELLA is a marketed brand name for linaclotide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of linaclotide?

linaclotide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.