Drugs / Teduglutide
Teduglutide
also known as
TED · ALX-0600 · Revestive · Gattex · Gattex kit · Teduglutida · Teduglutide (rdna origin) · Teduglutide recombinant
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed short bowel syndrome 1 milestone | |||||
| Filed | US (FDA) | GATTEX | short bowel syndrome | 2018-11-13 | “FDA has accepted for filing the supplemental new drug application to extend the indication of GATTEX ®” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | GATTEX KIT | — | 2014-06-26 – 2019-05-16 | fda.gov ↗ |
| Approved | US (FDA) | GATTEX KIT | — | 2012-12-21 | fda.gov ↗ |
| Approved | EU (EMA) | Revestive | — | 2012-08-30 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04290429 | Dec 2017 → Dec 2019 | graft versus host disease | University of Freiburg | Completed | No outcome recorded |
| Phase 16 trials · 1 missed | ||||||
| Phase 1 | NCT04465396 | Jan → Aug 2021 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01209351 | Sep → Nov 2010 | — | Shire | Completed | Missed primary |
| Phase 1 | NCT01028924 | Nov 2009 → Feb 2010 | — | Nycomed | Completed | No outcome recorded |
| Phase 1 | NCT01028768 | Oct 2009 → Jan 2010 | impaired renal function disease | Nycomed | Completed | No outcome recorded |
| Phase 1 | NCT00819468 | Jul → Aug 2007 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00820885 | Sep 2006 → Apr 2007 | — | Shire | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07537686 | Jul 2026 → Oct 2027 expected | — | International Centre for Diarrhoeal Disease Research, Bangladesh | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03716115 | May 2020 → Apr 2021 | protein-energy malnutrition | Queen Mary University of London | Completed | Mixed |
| Phase 2 | NCT02889393 | Jan 2019 → Jul 2020 | intestinal fistula | Daniel Dante Yeh | Completed | No outcome recorded |
| Phase 2 | NCT02431325 | Dec 2015 → Jan 2020 | HIV infectious disease | Massachusetts General Hospital | Completed | Mixed |
| Phase 2 | NCT00308438 | Mar 2004 → Nov 2005 | Crohn disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00072839 | Nov 2003 → Jul 2005 | Crohn disease | Shire | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03860688 | May 2019 → Dec 2021 | hyperlipidemia | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2/3 | NCT03442972 | Jan 2019 → Jun 2021 | hyperlipidemia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2/3 | NCT03422666 | Sep 2018 → Jun 2021 | hyperlipidemia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 317 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06973304 | Jun 2025 → Feb 2027 expected | short bowel syndrome | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05027308 | Jan 2022 → Sep 2023 | short bowel syndrome | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03571516 | Aug 2018 → Sep 2020 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT03596164 | Jul 2018 → Jan 2022 | short bowel syndrome | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03663582 | Jul 2018 → Aug 2019 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT03268811 | Aug 2017 → Nov 2021 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02980666 | Jan 2017 → Jan 2020 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02954458 | Jan 2017 → Nov 2020 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02949362 | Dec 2016 → Jul 2020 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02682381 | Jun 2016 → Aug 2017 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02340819 | Dec 2014 → Nov 2018 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01952080 | Nov 2013 → Jan 2015 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01560403 | May 2012 → Jul 2013 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00930644 | Sep 2009 → Jan 2013 | short bowel syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00798967 | Nov 2008 → Jan 2011 | short bowel syndrome | Shire | Completed | Met primary |
| Phase 3 | NCT00172185 | Jan 2005 → Jan 2008 | short bowel syndrome | Shire | Completed | Missed primary |
| Phase 3 | NCT00081458 | May 2004 → Jul 2007 | short bowel syndrome | Shire | Completed | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT03562130 | Jul 2018 → Dec 2019 | short bowel syndrome | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT02099084 | Jan 2014 → Mar 2015 | short bowel syndrome | Mayo Clinic | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT07400783 | Oct 2024 → Mar 2026 overdue | short bowel syndrome | Meyer Children's Hospital IRCCS | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT03534661 Comparator | Sep 2017 → Mar 2019 | hyperlipidemia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT03953170 Comparator | Jun → Nov 2022 | — | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-11-13 | Takeda | Regulatory U.S. FDA Accepts for Filing Shire’s Supplemental New Drug Application for GATTEX® (teduglutide [rDNA origin]) for Children with Short Bowel Syndrome takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) the global leader in rare diseases, announced today the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental new drug application to extend the indication of GATTEX ® (teduglutide [rDNA origin]) for Injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support. |
| 2016-07-07 | Takeda | Regulatory Shire Receives Extension of Market Authorization in Europe for Revestive ▼ (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (SBS) takeda.com ↗
The European Commission decision to grant extension of Market Authorization for Revestive in the treatment of paediatric patients with SBS follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in May 2016. |
| 2016-05-27 | Takeda | Regulatory Shire Receives Positive CHMP Opinion in Europe for Revestive® (Teduglutide) for Paediatric Patients with Short Bowel Syndrome takeda.com ↗
“We are delighted that the CHMP has rendered a favorable recommendation for teduglutide in paediatric patients based on their evaluation of the data and benefit-to-risk balance,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. |
All press releases naming this drug 4 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | teduglutide | “teduglutide 0.05 mg/kg/d injected subcutaneously daily.” NCT00072839 ↗37“Standard of care (SOC) treatment +/- teduglutide (TED)” NCT02954458 ↗ “teduglutide (a degradation resistant form of GLP-2)” NCT03860688 ↗ |
| Known as | ALX-0600 | “Teduglutide (ALX-0600)” NCT00308438 ↗1“Teduglutide (ALX-0600)” NCT07400783 ↗ |
| Known as | Gattex | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104987 ↗ |
| Known as | Gattex kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104987 ↗ |
| Known as | Revestive | “Teduglutide (Revestive®) is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the functional and structural integrity of the cells...” NCT03562130 ↗1“the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects).” NCT03442972 ↗ |
| Known as | TED | “AIM: To measure effects of a GLP-2 agonist, teduglutide (TED), compared with placebo (PLA) on gastric emptying (GE), overall gut transit, fluid balance, intestinal...” PMID 26223941 ↗ Jul 20152“We performed this proof-of-concept, feasibility, open-label, pilot randomized, crossover study to assess the efficacy and safety of the use of teduglutide (TED) to treat ECF.” PMID 35871951 ↗ May 2022 “Standard of care (SOC) treatment +/- teduglutide (TED)” NCT02954458 ↗ |
| Known as | Teduglutida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104987 ↗ |
| Known as | Teduglutide (rdna origin) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104987 ↗ |
| Known as | Teduglutide recombinant | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104987 ↗ |
| Action | Activate | “Glucagon-like peptide 2 receptor agonist” CHEMBL2104987 ↗ |
| Action | Restore | “Teduglutide, a glucagon-like peptide 2 analogue, might restore intestinal structural and functional integrity by promoting growth of the mucosa and reducing gastric emptying...” PMID 22982184 ↗ Sep 2012 |
| Modality | Peptide | “Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine.” NCT00172185 ↗ |
| Route | Subcutaneous | “injected subcutaneously” NCT00072839 ↗ |
| Target | GLP2R | “Glucagon-like peptide 2 receptor agonist” CHEMBL2104987 ↗ |