dexlansoprazole / Generic mfg. - LARVOL DELTA

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=71 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | Trial completion date: Oct 2027 ➔ Jul 2026 | Trial primary completion date: Oct 2027 ➔ Jul 2026

Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=71 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=24 | Terminated | Sponsor: Takeda | Trial completion date: Oct 2027 ➔ Apr 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2027 ➔ Apr 2026 | N=76 ➔ 24; Study related

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Takeda | Active, not recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: Takeda | Suspended ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Takeda | Suspended ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=76 | Suspended | Sponsor: Takeda | Active, not recruiting ➔ Suspended

Trial suspension • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Suspended | Sponsor: Takeda | Trial completion date: Nov 2018 ➔ Nov 2019 | Trial primary completion date: Nov 2018 ➔ Nov 2019

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Suspended | Sponsor: Takeda | Not yet recruiting ➔ Suspended

Trial suspension • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Suspended | Sponsor: Takeda | Trial completion date: Mar 2017 ➔ Jan 2021 | Initiation date: Nov 2015 ➔ Nov 2018 | Trial primary completion date: Jan 2017 ➔ Jan 2021

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Suspended | Sponsor: Takeda | Not yet recruiting ➔ Suspended

Trial suspension • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Takeda | Trial completion date: Jan 2025 ➔ Oct 2027 | Trial primary completion date: Jan 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Nov 2023 ➔ Jan 2025 | Trial primary completion date: Nov 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Sep 2026 ➔ Nov 2027 | Trial primary completion date: Sep 2026 ➔ Nov 2027

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Jan 2021 ➔ Nov 2023 | Trial primary completion date: Jan 2021 ➔ Nov 2023

Trial completion date • Trial primary completion date • Gastroesophageal Reflux Disease • Pediatrics

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Nov 2019 ➔ Sep 2026 | Trial primary completion date: Nov 2019 ➔ Sep 2026

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Pediatrics

Alembic receives USFDA approval for Dexlansoprazole delayed-release capsules (ExpressPharma) - "The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: (i) healing of all grades of erosive esophagitis (EE), (ii) maintenance of healed EE and relief of heartburn, and (iii) treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD)."

ANDA • Gastrointestinal Disorder

Effect of Dexlansoprazole on Bone Homeostasis (clinicaltrials.gov) - P1 | N=115 | Completed | Sponsor: Takeda | N=247 ➔ 115

Enrollment change

Devonian Announces that its Subsidiary, Altius, Launches Authorized Generic of Dexlansoprazole (Dexilant) in Canada (Businesswire) - "Devonian Health Group Inc...is pleased to announce that its wholly-owned subsidiary, Altius Healthcare Inc. ('Altius'), has launched the first authorized generic of dexlansoprazole (Dexilant) in Canada to treat symptoms of gastroesophageal reflux disease (GERD)....Altius’ authorized generic dexlansoprazole is now available in pharmacies for patients across Canada."

Generic launch • Gastroenterology • Gastrointestinal Disorder

BABE: Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: University of Karachi | Recruiting ➔ Completed

Trial completion