Pramlintide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SYMLIN | — | 2014-06-27 | fda.gov ↗ |
| Approved | US (FDA) | SYMLIN | — | 2005-03-16 | fda.gov ↗ |
Trials 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03560960 | Feb 2020 → Nov 2026 expected | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Boston University | Active not recruiting | No outcome recorded |
| Phase 0 | NCT04252612 | Jan 2020 → Jun 2023 | skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT02500979 | Aug 2015 → Aug 2016 | type 1 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01708044 | Nov 2012 → Sep 2013 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 211 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT04074317 | Aug 2019 → Apr 2020 | type 1 diabetes mellitus | Xeris Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03800875 | Feb 2019 → Sep 2020 | type 1 diabetes mellitus | McGill University | Completed | Missed primary |
| Phase 2 | NCT01235741 | Jan → Sep 2011 | obesity disorder | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00819234 | Nov 2008 → Oct 2009 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00673387 | Apr 2008 → Apr 2009 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00402077 | Nov 2006 → Aug 2007 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00392925 | Oct 2006 → Sep 2007 | obesity disorder | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00313183 | Apr 2006 → Aug 2007 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00189514 | Sep 2005 → Jun 2007 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00112021 | May → Nov 2005 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00042471 | Jun → Dec 2002 | type 1 diabetes mellitus, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06619015 | Apr 2025 | obesity disorder, prediabetes syndrome | Esbjerg Hospital - University Hospital of Southern Denmark | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT06046417 | Nov 2023 → Apr 2025 | type 1 diabetes mellitus | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01137695 | May 2010 → Jan 2012 | type 2 diabetes mellitus | Cheryl Rosenfeld, DO | Unknown | No outcome recorded |
| Phase 3 | NCT00206297 | Oct 2003 → Feb 2006 | type 1 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00108004 | Apr 2003 → Jun 2005 | type 1 diabetes mellitus, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00206258 | Jul 2002 → Aug 2005 | type 1 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 48 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT01841359 | Feb 2010 → Jul 2016 | hypoglycemia | Joslin Diabetes Center | Completed | Missed primary |
| Phase 4 | NCT01269047 | Aug 2009 → Aug 2016 | type 1 diabetes mellitus | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00690235 | Nov 2007 → Aug 2011 | diabetes mellitus, schizoaffective disorder, schizophrenia | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00502138 | Jul 2007 → Jan 2008 | type 1 diabetes mellitus | University Diabetes & Endocrine Consultants | Completed | No outcome recorded |
| Phase 4 | NCT00505882 | Jul 2007 → Dec 2008 | type 1 diabetes mellitus | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00467649 | May 2007 → Apr 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00442767 | Feb 2007 → Feb 2009 | type 1 diabetes mellitus | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00291772 | Jan 2006 → Nov 2007 | type 1 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT07340775 | Feb 2026 → Dec 2028 expected | brain disorder, headache disorder | Danish Headache Center | Not yet recruiting | No outcome recorded |
| — | NCT07340788 | Feb 2026 → Oct 2028 expected | migraine disorder | Danish Headache Center | Not yet recruiting | No outcome recorded |
| — | NCT05199714 | Feb 2022 → Mar 2023 | type 1 diabetes mellitus | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| — | NCT04243629 | Nov 2021 → Apr 2024 | hyperglycemia, type 1 diabetes mellitus | McGill University | Unknown | No outcome recorded |
| — | NCT03993366 | Mar → Aug 2019 | type 1 diabetes mellitus | McGill University | Completed | No outcome recorded |
| — | NCT01434862 | Feb 2011 → Feb 2012 | type 1 diabetes mellitus | University of Virginia | Terminated | No outcome recorded |
| — | NCT00732147 | Apr 2009 → Apr 2011 | type 2 diabetes mellitus | University of Maryland, Baltimore | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00460304 | Sep 2007 → Nov 2008 | type 1 diabetes mellitus | Diabetes Care Center | Completed | No outcome recorded |
| — | NCT00842075 | Dec 2006 → Dec 2009 | type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00489645 | Jan 2005 → Mar 2007 | type 1 diabetes mellitus | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT03916640 Comparator | Jan → Mar 2019 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT03512236 Comparator | Apr 2018 → Feb 2019 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1/2 | NCT01165944 Comparator | Aug 2009 → Aug 2011 | diabetes mellitus | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2 | NCT00444561 Comparator | Aug 2004 → May 2005 | obesity disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00044707 Comparator | Aug → Sep 2002 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00042601 Comparator | Jul 2002 → Oct 2003 | type 1 diabetes mellitus, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00107107 Comparator | Nov 2002 → Jun 2005 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00042458 Comparator | Apr 2002 → Mar 2003 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00950677 Comparator | Jul 2009 → May 2011 | type 2 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00240253 Comparator | Oct 2005 → Jun 2006 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| — | NCT07506369 Comparator | Apr → Oct 2026 expected | obesity disorder | University Hospital, Gentofte, Copenhagen | Recruiting | No outcome recorded |
| — | NCT04163874 Comparator | Feb 2020 → Jan 2022 | hyperglycemia, type 1 diabetes mellitus | McGill University | Completed | No outcome recorded |
| — | NCT00691158 Comparator | Jan 2006 → Jul 2024 | obesity disorder | Oregon Health and Science University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
All press releases naming this drug 19 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pramlintide | “We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input.” PMID 34580055 ↗ Sep 202149“Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine.” NCT07340788 ↗ “Pramlintide is a peptide analogue of human amylin which is a vasoactive substance involved in the pathogenesis of headache.” NCT07340775 ↗ “simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®)” NCT03512236 ↗ |
| Known as | AC-0137 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | AC137 | “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc.” NCT00042601 ↗4“Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC administration.” NCT00444561 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection.” NCT00042458 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection.” NCT00044707 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection.” NCT00042471 ↗ |
| Known as | Amylin | “Pramlintide (Amylin) will be administered by intravenous infusion.” NCT07340775 ↗1“Pramlintide (Amylin) will be administered by intravenous infusion.” NCT07340788 ↗ |
| Known as | PRAM | “mealtime pramlintide (PRAM) (120 microg fixed dose; n = 56)” PMID 20199136 ↗ May 2010 |
| Known as | Pramlintida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | Pramlintide acetate | “Symlin (R) (Pramlintide acetate) 1000mcg/ml, will be administered as a continuous infusion at a rate of 15mcg/hour, equivalent to the daily recommended maximum dosage of 360mcg/day.” NCT06619015 ↗13“Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc.” NCT00042601 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC administration.” NCT00444561 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection.” NCT00044707 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection.” NCT00042458 ↗ “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection.” NCT00042471 ↗ “Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection.” NCT00107107 ↗ “Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection.” NCT00108004 ↗ “Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks” NCT00392925 ↗ “Drug: pramlintide acetate” NCT00402077 ↗ “Drug: pramlintide acetate” NCT00112021 ↗ |
| Known as | Pramlintide acetate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | Pramlintide acetate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | Pramlintide: SYMLIN | “Pramlintide: SYMLIN” NCT02500979 ↗ |
| Known as | Symlin | “The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times...” NCT01137695 ↗6“The investigators hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM would help patients with post-transplant diabetes attain better...” NCT01165944 ↗ “The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not...” NCT00240253 ↗ “This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night” NCT00502138 ↗ “simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®)” NCT03512236 ↗ “The medicines are called Symlin (pramlintide) and Byetta (exenatide).” NCT00950677 ↗ |
| Known as | Symlin (pramlintide acetate) | “Symlin (pramlintide acetate)” NCT00042471 ↗ |
| Known as | Symlin pen | “pramlintide (Symlin® pen)” NCT04074317 ↗ |
| Known as | Tripro-amylin | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | Tripro-amylin acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Known as | Tripro-amylin acetate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103758 ↗ |
| Action | Inhibit | “Pramlintide administration suppressed glucagon” PMID 15793249 ↗ Apr 2005 |
| Modality | Peptide | “either an amylin analog (pramlintide) or placebo” NCT06619015 ↗ |
| Route | Subcutaneous | “Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection.” NCT00042458 ↗ |