Drugs / Theophylline
Theophylline
also known as
Theophylline ER · QuibronT/SR · Theophyllin · theophylline SR · Unicontin-E · uniphyllin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LANOPHYLLIN | — | 1976-07-26 | fda.gov ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04309877 | Mar 2023 → Jun 2025 | depressive disorder | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 0 | NCT04269187 | Apr 2020 → Apr 2022 | diaphragmatic malformation | Assiut University | Unknown | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT06189404 | Oct → Nov 2023 | gout | LG Chem | Completed | No outcome recorded |
| Phase 1 | NCT02080078 | Sep 2014 → Mar 2019 | non-small cell lung carcinoma | AHS Cancer Control Alberta | Terminated | No outcome recorded |
| Phase 1 | NCT01263106 | Dec 2010 → Jan 2011 | major depressive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01017939 | Jan → Jun 2010 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00983905 | Aug → Sep 2008 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02273440 | May → Jul 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02184247 | Apr → May 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05853601 | Oct 2023 → May 2027 expected | acute kidney injury, perinatal asphyxia | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00175812 | Nov 2004 → May 2008 | acute myeloid leukemia | University of Bergen | Completed | No outcome recorded |
| Phase 212 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05717049 | Feb → Sep 2023 | congenital heart disease | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05947643 | Nov 2022 → Apr 2025 | COVID-19 | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT05076682 | Jun 2022 → Dec 2026 expected | triple-negative breast carcinoma | Fudan University | Recruiting | Met primary |
| Phase 2 | NCT04789499 | Mar → Dec 2021 | COVID-19, amusia, anosmia, olfactory nerve disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04551170 | Jul 2020 → Dec 2026 expected | pseudohypoparathyroidism type 1A | Vanderbilt University Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04240821 | May 2020 → Dec 2026 expected | pseudohypoparathyroidism type 1A | Jaclyn Tamaroff | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT03990766 | May 2019 → Jan 2021 | anosmia, olfactory nerve disorder, viral respiratory tract infection | Washington University School of Medicine | Completed | Missed primary |
| Phase 2 | NCT03029429 | Sep 2018 → Dec 2026 expected | pseudopseudohypoparathyroidism | Vanderbilt University Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02479451 | Oct 2015 → Jul 2022 | end stage renal failure, olfactory nerve disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02463409 | Jun 2015 → Oct 2016 | pseudohypoparathyroidism type 1A | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00634413 | Feb → Dec 2008 | chronic obstructive pulmonary disease | Pulmagen Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00003808 | Aug 1999 → Sep 2002 | leukemia | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT03319121 | Mar 2015 → Dec 2017 | — | Universiti Sains Malaysia | Completed | Met primary |
| Phase 2/3 | NCT01902758 | Aug 2013 | acute mountain sickness | University of Montana | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT03984188 | Feb 2021 → Oct 2023 | chronic obstructive pulmonary disease | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT02340520 | Dec 2014 → Aug 2016 | chronic obstructive pulmonary disease | UConn Health | Completed | No outcome recorded |
| Phase 3 | NCT01599871 | Jan 2011 → Dec 2015 | chronic obstructive pulmonary disease | Hospital Son Espases | Completed | No outcome recorded |
| Phase 3 | NCT00252785 | Oct 2005 → Nov 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00252863 | Dec 2004 → May 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00003684 | Mar 1998 → Dec 2008 | cancer of unknown primary site | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00000578 | Apr 1994 → Oct 2000 | asthma, lung disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 410 trials · 1 missed | ||||||
| Phase 4 | NCT07171021 | Dec 2020 → Dec 2023 | anosmia | Taichung Veterans General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03718403 | Nov 2019 → Apr 2030 expected | — | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03269318 | Jul 2017 → Aug 2019 | asthma | Brighton and Sussex University Hospitals NHS Trust | Terminated | No outcome recorded |
| Phase 4 | NCT01769898 | Jul 2013 → Sep 2014 | bronchiectasis | The First Affiliated Hospital of Guangzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01794780 | Feb 2013 → May 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01684683 | Nov 2012 → Apr 2014 | bronchiectasis | The First Affiliated Hospital of Guangzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01601132 | May → Jul 2012 | — | Takeda | Completed | Missed primary |
| Phase 4 | NCT01010178 | Feb 2008 → Apr 2009 | chronic obstructive pulmonary disease | Baqiyatallah Medical Sciences University | Completed | No outcome recorded |
| Phase 4 | NCT00157937 | Feb 2003 → Jun 2005 | allergic rhinitis, asthma | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00492518 | Feb 2002 → Oct 2004 | acute tubulointerstitial nephritis, kidney failure | Technical University of Munich | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07515456 | Dec 2024 → Nov 2026 expected | intracranial hypotension | Tanta University | Recruiting | No outcome recorded |
| — | NCT04148846 | Sep 2019 → Sep 2020 | headache disorder | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| — | NCT03015090 | Jan → Jun 2017 | chronic obstructive pulmonary disease | XiaoGuang Zou | Completed | No outcome recorded |
| — | NCT03115294 | May 2016 → Oct 2019 | — | Tampere University Hospital | Completed | No outcome recorded |
| — | NCT02023554 | Dec 2013 → Jul 2014 | asthma, chronic obstructive pulmonary disease | Zhujiang Hospital | Completed | No outcome recorded |
| — | NCT02001935 | Sep 2013 → Jul 2014 | chronic obstructive pulmonary disease | Zhujiang Hospital | Completed | No outcome recorded |
| Comparator or background therapy21 trials | ||||||
| Phase 1 | NCT01799161 Comparator | Dec 2014 → Apr 2018 | non-small cell lung carcinoma | Eckhard Podack | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01566565 Comparator | Mar → May 2012 | pulmonary hypertension | Norwegian Armed Forces Medical Service | Completed | No outcome recorded |
| Phase 1 | NCT00779259 Comparator | Aug → Sep 2007 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01132781 Comparator | May 2010 → Jun 2012 | allergic rhinitis, asthma, sinusitis | University of East Anglia | Completed | No outcome recorded |
| Phase 2 | NCT01293734 Comparator | Dec 2008 → Jan 2011 | acute asthma | Liaoning University of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00241631 Comparator | Apr 2006 → Aug 2007 | chronic obstructive pulmonary disease | Imperial College London | Completed | No outcome recorded |
| Phase 2/3 | NCT02088502 Comparator | Sep 2013 → Apr 2014 | — | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT00299858 Comparator | Oct 2006 → May 2010 | chronic obstructive pulmonary disease | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT00119496 Comparator | Jul 2005 → Jun 2007 | asthma | University of Glasgow | Completed | No outcome recorded |
| Phase 2/3 | NCT01066728 Comparator | Aug 2001 → Sep 2005 | apnea of prematurity | University of Manitoba | Completed | No outcome recorded |
| Phase 4 | NCT04257851 Comparator | Feb 2020 → May 2021 | intracranial hypotension | Damanhour Teaching Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02537691 Background | Aug 2015 → Jul 2017 | asthma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02261727 Comparator | Jun 2014 → May 2018 | chronic obstructive pulmonary disease | The George Institute | Completed | No outcome recorded |
| Phase 4 | NCT01696214 Comparator | Oct 2012 → May 2015 | asthma | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT01415518 Background | Sep 2011 → Dec 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00756418 Comparator | Jun 2003 → Aug 2004 | asthma | Organon and Co | Completed | Met primary |
| — | NCT03894189 Comparator | May → Dec 2019 | — | Beni-Suef University | Unknown | No outcome recorded |
| — | NCT02790047 Background | Oct 2016 → Jan 2018 | chronic obstructive pulmonary disease | Khon Kaen University | Unknown | No outcome recorded |
| — | NCT02257463 Comparator | Oct 2011 → Apr 2014 | chronic obstructive pulmonary disease | Mansoura University | Completed | No outcome recorded |
| — | NCT00893009 Comparator | Jul → Oct 2009 | chronic obstructive pulmonary disease | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| — | NCT00671151 Comparator | Jun 2005 → Dec 2007 | chronic obstructive pulmonary disease | Hospital Universitari Son Dureta | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Theophylline | “Theophylline SR 250 mg daily for functional chest pain for 4 weeks” NCT03319121 ↗67“Xanthine derivative (sustained release theophylline)” NCT02790047 ↗ |
| Known as | QuibronT/SR | “Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours.” NCT07515456 ↗ |
| Known as | Theophyllin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00175812 ↗ |
| Known as | Theophylline ER | “Comparator: theophylline ER/Duration of Treatment: 16 weeks” NCT00157937 ↗ |
| Known as | theophylline SR | “theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)” NCT01415518 ↗ |
| Known as | Unicontin-E | “Participants will be randomly assigned to receive once daily low-dose theophylline (200 mg ER, Unicontin-E) or placebo for 52 weeks.” PMID 33726828 ↗ Mar 2021 |
| Known as | uniphyllin | “pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators” NCT02257463 ↗ |
| Action | Inhibit | “inhibits cyclic nucleotide phosphodiesterases” PMID 15356646 ↗ Oct 2004 |
| Modality | Small molecule | “a methylxanthine that inhibits cyclic nucleotide phosphodiesterases” PMID 15356646 ↗ Oct 2004 |
| Route | Oral | “active oral theophylline” NCT00000578 ↗ |