Drugs / Lubiprostone
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | AMITIZA | — | 2008-04-29 – 2018-04-26 | fda.gov ↗ |
| Approved | US (FDA) | AMITIZA | — | 2006-01-31 | fda.gov ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00934479 | Apr 2010 → Feb 2012 | constipation disorder, irritable bowel syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06543979 | Sep 2024 → Sep 2025 overdue | constipation disorder | Ain Shams University | Recruiting | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT07405736 | Feb 2026 → Jun 2027 expected | metastasis from malignant tumor of colon, peritoneal carcinomatosis | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02544152 | Feb 2015 → Dec 2016 | irritable bowel syndrome | Sucampo Pharma Americas, LLC | Terminated | Missed primary |
| Phase 2 | NCT01839734 | Jun 2013 → Apr 2014 | HIV infectious disease | Ruth M. Rothstein CORE Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01469819 | Jun 2012 → Feb 2015 | constipation disorder | Texas Tech University Health Sciences Center, El Paso | Completed | No outcome recorded |
| Phase 318 trials · 6 met primary · 3 missed | ||||||
| Phase 3 | NCT07277907 | Nov 2025 → Oct 2027 expected | intestinal dysmotility syndrome | Third Military Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT05144295 | Jan → Aug 2022 | — | Alexandria University | Completed | No outcome recorded |
| Phase 3 | NCT03010631 | Nov → Dec 2016 | — | Sucampo Pharma Americas, LLC | Completed | Missed primary |
| Phase 3 | NCT02729909 | May 2016 → Apr 2017 | constipation disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT02695719 | Apr 2016 → Jan 2017 | constipation disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT02766777 | Apr → Nov 2016 | constipation disorder | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02651155 | Mar 2016 → Jan 2017 | constipation disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT02138136 | Feb 2014 → May 2017 | constipation disorder | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02042183 | Dec 2013 → Jul 2016 | constipation disorder | Sucampo Pharma Americas, LLC | Completed | Missed primary |
| Phase 3 | NCT01993875 | Oct 2013 → Jan 2014 | constipation disorder | Mallinckrodt | Completed | Missed primary |
| Phase 3 | NCT01372423 | May 2011 → Jun 2012 | constipation disorder | Anchen Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01324284 | Mar → Jun 2011 | colorectal carcinoma | Asian Institute of Gastroenterology, India | Completed | No outcome recorded |
| Phase 3 | NCT01298219 | Dec 2010 → Nov 2011 | opioid-induced constipation | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00620061 | Dec 2007 → Sep 2009 | opioid-induced constipation | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00597428 | Aug 2007 → Mar 2009 | opioid-induced constipation | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00595946 | Aug 2007 → Mar 2009 | opioid-induced constipation | Sucampo Pharma Americas, LLC | Completed | Met primary |
| Phase 3 | NCT00399542 | May 2005 → Jul 2006 | constipation disorder, irritable bowel syndrome | Sucampo Pharma Americas, LLC | Completed | Met primary |
| Phase 3 | NCT00380250 | May 2005 → Jul 2006 | irritable bowel syndrome | Sucampo Pharma Americas, LLC | Completed | Met primary |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT04985669 | Aug 2021 → Feb 2022 | — | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 4 | NCT04138004 | Dec 2019 → Jun 2021 | — | Department of Medical Services Ministry of Public Health of Thailand | Completed | No outcome recorded |
| Phase 4 | NCT01096290 | Apr 2010 → Sep 2012 | constipation disorder | University of South Alabama | Terminated | No outcome recorded |
| Phase 4 | NCT00844831 | May 2009 → May 2011 | constipation disorder | University of Louisville | Completed | Missed primary |
| Phase 4 | NCT01460225 | Sep 2007 → Dec 2010 | constipation disorder | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00452335 | Jan 2007 → Oct 2008 | constipation disorder | Sucampo Pharma Americas, LLC | Completed | No outcome recorded |
| Phase not applicable4 trials · 2 missed | ||||||
| — | NCT00669461 | Jun 2009 → Sep 2010 | Parkinson disease, constipation disorder | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00706004 | Jul 2008 → Dec 2009 | constipation disorder, cystic fibrosis | University of Arkansas | Completed | No outcome recorded |
| — | NCT00689026 | May 2008 → Mar 2010 | type 1 diabetes mellitus, type 2 diabetes mellitus | Augusta University | Terminated | Missed primary |
| — | NCT00662363 | Apr 2008 → Oct 2011 | constipation disorder | Shirley Ryan AbilityLab | Completed | Missed primary |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT01190020 Comparator | Feb 2009 → Mar 2012 | constipation disorder | Augusta University | Completed | No outcome recorded |
| Phase 1 | NCT01166789 Comparator | Feb 2008 → Aug 2010 | irritable bowel syndrome | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2/3 | NCT01447849 Comparator | Aug 2011 → Nov 2012 | constipation disorder | Texas Tech University Health Sciences Center, El Paso | Completed | No outcome recorded |
| Phase 3 | NCT05768334 Comparator | Nov 2020 → Feb 2023 | NAFLD1 | Helwan University | Completed | No outcome recorded |
| Phase 3 | NCT02481947 Comparator | May → Nov 2015 | constipation disorder | Braintree Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01674530 Comparator | Oct 2012 → Jan 2014 | constipation disorder | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 4 | NCT01236534 Comparator | Nov 2010 → Jan 2012 | constipation disorder, multiple sclerosis | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT01170039 Comparator | Sep 2010 → Oct 2014 | constipation disorder, diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00953017 Comparator | Jul 2009 → May 2010 | — | Brooke Army Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00908076 Comparator | Feb 2009 → Oct 2010 | Parkinson disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00746395 Comparator | Apr → Sep 2008 | inflammatory bowel disease | University of South Alabama | Completed | No outcome recorded |
| Phase 4 | NCT00645801 Comparator | Mar 2008 → Jul 2011 | — | Henry Ford Health System | Completed | No outcome recorded |
| Phase 4 | NCT00953043 Comparator | Sep 2007 → Jul 2008 | — | Mayo Clinic | Completed | No outcome recorded |
| — | NCT01162863 Comparator | Nov 2010 → Dec 2012 | constipation disorder, irritable bowel syndrome | University of Michigan | Completed | No outcome recorded |
| — | NCT01085643 Comparator | Mar → Dec 2010 | irritable bowel syndrome | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| — | NCT00611442 Comparator | Oct 2007 → Jan 2008 | — | Brooke Army Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | Mallinckrodt | Results Keenova Announces Unaudited Fourth Quarter 2025 Financial Results gcs-web.com ↗
XIAFLEX also performed well in the fourth quarter, and today we announced a significant milestone in our hammer toe clinical program. |
| 2023-03-24 | Zydus Lifesciences Limited | Regulatory Zydus receives Final Approval from the USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereinafter referred to as “Zydus”) has received final approval for Lubiprostone Capsules, 8 mcg and 24 mcg (USRLD: Amitiza® Capsules) from the United States Food and Drug Administration (USFDA). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | Takeda | Takeda Updates FY2025 Financial Results Based on Impact of AMITIZA® Antitrust Verdict takeda.com ↗ |
| 2026-05-19 | Takeda | Takeda Provides an Update regarding Jury Verdict in AMITIZA® (lubiprostone) Antitrust Litigation in the U.S. and Related Revision to FY2025 Financial Results takeda.com ↗ |
| 2026-03-31 | Mallinckrodt | Keenova Announces Unaudited Fourth Quarter 2025 Financial Results gcs-web.com ↗ |
| 2023-03-24 | Zydus Lifesciences Limited | Zydus receives Final Approval from the USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg zyduslife.com ↗ |
| 2014-10-22 | Takeda | Takeda and Sucampo Enter Into Global Licensing Agreement for AMITIZA ® (lubiprostone) takeda.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lubiprostone | “The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in...” NCT00908076 ↗50“One group of patient will receive prucalopride 2mg daily and another group of patient will receive lubiprostone 8 microgram twice daily.” NCT04985669 ↗ “Amitiza (Lubiprostone)” NCT00953017 ↗ |
| Known as | AMITIZA | “The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation...” NCT01372423 ↗4“The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in...” NCT00908076 ↗ “OBJECTIVE: To evaluate the efficacy and tolerability of lubiprostone (Amitiza) for constipation in Parkinson disease (PD) in a double-blind, randomized, controlled study.” PMID 22573627 ↗ May 2012 “marketed formulation AMITIZA® ( Lubiprostone ) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)” NCT01674530 ↗ |
| Known as | Lubiprostona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201134 ↗ |
| Known as | Lubiprostone hemiketal | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201134 ↗ |
| Known as | RU-0211 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201134 ↗ |
| Known as | SPI-0211 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201134 ↗ |
| Action | Activate | “Lubiprostone (Amitiza®) is a locally acting chloride channel activator that increases intestinal fluid, and thus increases intestinal motility.” NCT00662363 ↗1“Chloride channel protein 2 opener” CHEMBL1201134 ↗ |
| Modality | Small molecule | “an orally active, bicyclic fatty acid” NCT00934479 ↗ |
| Route | Oral | “OBJECTIVE: To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain.” PMID 24716835 ↗ Apr 2014 |
| Target | CLCN2 | “Chloride channel protein 2 opener” CHEMBL1201134 ↗ |
| Target | P2RY2 | “lubiprostone demonstrated inhibitory effects on P2RY2-associated signaling” NCT07405736 ↗ |