theophylline extended-release / Generic mfg. - LARVOL DELTA

Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders • Metabolic Disorders

Theophylline for Treatment of Pseudohypoparathyroidism (clinicaltrials.gov) - P2 | N=34 | Enrolling by invitation | Sponsor: Ashley Shoemaker | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders

Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders

Zydus Lifesciences gets USFDA nod for asthma treatment drug (The Economic Times) - "Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Theophylline extended-release tablets used in the treatment of asthma and chronic obstructive pulmonary disease. The approval by the US Food and Drug Administration (USFDA) is for Theophylline extended-release tablets of strengths 300 mg and 450 mg, Zydus Lifesciences said in a regulatory filing."

ANDA • Asthma • Chronic Obstructive Pulmonary Disease

Theophylline Treatment for Pseudohypoparathyroidism (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Theophylline for Treatment of Pseudohypoparathyroidism (clinicaltrials.gov) - P2 | N=34 | Enrolling by invitation | Sponsor: Ashley Shoemaker | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD (clinicaltrials.gov) - P3 | N=100 | Completed | Sponsor: University of Miami | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Theophylline Treatment for Pseudohypoparathyroidism (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Nov 2024 ➔ Nov 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD (clinicaltrials.gov) - P3 | N=110 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Theophylline Treatment for Pseudohypoparathyroidism (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Nov 2023 ➔ Nov 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD (clinicaltrials.gov) - P3 | N=110 | Recruiting | Sponsor: University of Miami | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

T-DEP: Theophylline for Depression Study (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: University of California, Los Angeles; N=20 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CNS Disorders • Depression • Mood Disorders • Psychiatry

T-DEP: Theophylline for Depression Study (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: University of California, Los Angeles; Trial completion date: Jun 2021 ➔ Jun 2025; Trial primary completion date: Jun 2021 ➔ Jun 2025

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Theophylline Treatment for Pseudohypoparathyroidism (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Vanderbilt University Medical Center; Trial completion date: Nov 2021 ➔ Nov 2023; Trial primary completion date: Jul 2021 ➔ Jul 2023

Trial completion date • Trial primary completion date • Endocrine Disorders • Metabolic Disorders • Renal Disease

Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity on the 450 mg (Glenmark Press Release) - "Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Theophylline Extended Release Tablets, 300 mg and 450 mg, bioequivalent and therapeutically equivalent to the reference listed drug, Theophylline Extended-Release Tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited. Glenmark has been granted a competitive generic therapy (CGT) designation for Theophylline Extended-Release Tablets USP, 450 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg strength."

ANDA • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases