dexlansoprazole / Generic mfg. - LARVOL DELTA

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

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

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

A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder • Pediatrics

A Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

"@TakedaPharma are they any manufacturer coupons for dexilant 30mg in the new year? If so where can I get one?" (@EeyoreHMC)

Effectiveness of Physiologic Testing in PPI Non-Responders (clinicaltrials.gov) - P1 | N=240 | Completed | Sponsor: Northwestern University | Enrolling by invitation ➔ Completed | Trial completion date: Mar 2022 ➔ Jul 2022 | Trial primary completion date: Mar 2022 ➔ Jul 2022

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

"And DexilANT" (@BassoonYsu)

BABE: Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Karachi | Trial completion date: Nov 2021 ➔ Nov 2023 | Trial primary completion date: Oct 2021 ➔ Oct 2023

Trial completion date • Trial primary completion date

"@TakedaPharma are there any dexilant manufacturers coupons u could send me?" (@EeyoreHMC)

Addendum: Dexlansoprazole for GERD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroesophageal Reflux Disease

Comparison tables: H2-receptor antagonists and PPIs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Peptic Ulcer

Drugs for GERD and peptic ulcer disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Infectious Disease • Peptic Ulcer

"@TakedaPharma I can't get my Dexilant Savings Card to work at Rite Aid and I can't anyone to pick up the Dexilant Advantage phone #. Please help! My new insurance won't cover PPIs." (@goldfine)

Reimbursement

"Dexilant Savings Program is ending and the generic version is launching, are you guys giving up on the drug?" (@beignetbinch)

Generic launch

Effectiveness of Physiologic Testing in PPI Non-Responders (clinicaltrials.gov) - P1; N=240; Enrolling by invitation; Sponsor: Northwestern University; Trial primary completion date: Oct 2021 ➔ Mar 2022

Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease

BABE: Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: University of Karachi; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2021 ➔ Nov 2021; Initiation date: Jun 2021 ➔ Sep 2021; Trial primary completion date: Jul 2021 ➔ Oct 2021

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date

"@TakedaPharma why I can't find/buy #Dexilant 30 mg in Ukraine anymore? 🙄😞" (@snobnab)

A Phase 2 Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Pediatric Subjects Aged 1 to 11 Years (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

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

A Phase 2, Double Blind Study to Assess Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Participants (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

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

"@TakedaPharma Hi How are you? My doctor wants me to use Dexilant for 3 months. I cannot afford the $387 price for 30 tables. Does Takeda offer any assistance ? Thank you God Bless!!🙏😇🙏" (@piroumian)

Pricing

"@TakedaPharma why dont have dexilant in México?" (@AlfonsoCntreras)

BABE: Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: University of Karachi

Clinical • New P1 trial