Drugs / Pyridostigmine
Pyridostigmine
also known as
pyridostigmine bromide · Mestinon · Bromure de pyridostigmine · Bromuro de piridostigmina · Kalimin · Kalymin · Mestinon 10 · Mestinon ret · +9 more
Small molecule targets ACHE via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MESTINON | — | 1955-04-06 | fda.gov ↗ |
Trials 25
1954195519561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT02850276 | Nov 2015 → Jun 2018 | HIV infectious disease | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 0 | NCT02357225 | Aug 2015 → Jan 2018 | glycogen storage disease II | University of Florida | Terminated | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT07154095 | Aug → Nov 2023 | myasthenia gravis | West China Second University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03124355 | Sep 2017 → Jun 2027 expected | postural orthostatic tachycardia syndrome | Vanderbilt University Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT00276406 | May 2006 → Oct 2010 | constipation disorder, diabetes mellitus | Mayo Clinic | Completed | Met primary |
| Phase 212 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06319469 | Feb 2023 → Jan 2024 | benign prostatic hyperplasia | Beni-Suef University | Completed | No outcome recorded |
| Phase 2 | NCT05603715 | Aug 2022 → Dec 2026 expected | Parkinson disease, constipation disorder | University of Vermont Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03312244 | Jul 2019 → Jun 2021 | HIV infectious disease, immunodeficiency disease, lymphopenia | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02893553 | Dec 2016 → Dec 2021 | autonomic dysreflexia, cognitive disorder, hypotensive disorder, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02941328 | Dec 2015 → Jan 2018 | spinal muscular atrophy | UMC Utrecht | Completed | Missed primary |
| Phase 2 | NCT02227823 | Jul 2014 → Jul 2017 | spinal muscular atrophy, type III | Centre Hospitalier Régional de la Citadelle | Completed | No outcome recorded |
| Phase 2 | NCT01993680 | Jun 2012 → Apr 2015 | Parkinson disease | Christian Baumann | Completed | No outcome recorded |
| Phase 2 | NCT01370512 | Nov 2011 → May 2027 expected | orthostatic hypotension | Mayo Clinic | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT01415921 | Oct 2011 → Jul 2015 | systolic heart failure | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT02307526 | Jan 2011 → Mar 2015 | orthostatic hypotension | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00518154 | Sep 2007 → Nov 2008 | HIV infectious disease | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 2 | NCT00535587 | Sep 2002 → Jun 2008 | fibromyalgia | Oregon Health and Science University | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05334485 | Sep 2024 → Sep 2026 overdue | ileus | Stefan Holubar MD MS FACS, FASCRS | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05919407 | Mar 2023 → Sep 2024 | myasthenia gravis | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05969119 | Jul 2023 → Jan 2024 | headache disorder | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT05110417 | May 2021 → Dec 2022 | spasmodic dystonia, voice disorders | Eastern Virginia Medical School | Unknown | No outcome recorded |
| Phase 4 | NCT03510546 | Apr 2018 → Aug 2020 | myasthenia gravis | University of Aarhus | Unknown | No outcome recorded |
| Phase 4 | NCT02308124 | Nov 2014 → Sep 2016 | orthostatic hypotension | Seoul National University Hospital | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00953914 | Mar 2005 → Jul 2009 | — | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 0 | NCT03261570 Comparator | Jul 2017 → Jun 2022 | postural orthostatic tachycardia syndrome | New York Medical College | Completed | No outcome recorded |
| Phase 1 | NCT03063515 Comparator | Apr 2017 → Dec 2018 | diabetes mellitus | University of Miami | Completed | No outcome recorded |
| Phase 1/2 | NCT04353778 Comparator | Aug 2020 → Sep 2026 overdue | HIV infectious disease, vagus nerve disorder | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT06366724 Comparator | Sep 2024 → Sep 2026 overdue | long COVID-19, myalgic encephalomeyelitis/chronic fatigue syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06915181 Comparator | Dec 2023 → May 2024 | systemic sclerosis | University Hospital Brussels | Withdrawn | No outcome recorded |
| Phase 2 | NCT04226170 Background | Nov 2023 → Apr 2025 | AChR+ myasthenia gravis | DAS-MG, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03674541 Comparator | Jan 2020 → Dec 2021 | dysautonomia, fibromyalgia, myalgic encephalomeyelitis/chronic fatigue syndrome, orthostatic hypotension +1 | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00409435 Comparator | Oct 2006 → Feb 2027 expected | postural orthostatic tachycardia syndrome | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04343963 Comparator | Apr → Sep 2020 | COVID-19 | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Unknown | No outcome recorded |
| Phase 4 | NCT06753071 Comparator | Apr → Jul 2024 | benign prostatic hyperplasia, urinary bladder disorder | Menoufia University | Completed | No outcome recorded |
| Phase 4 | NCT06035757 Comparator | Dec 2023 → Mar 2026 | childhood acute lymphoblastic leukemia, delirium, strabismus | Konkuk University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02171988 Comparator | Mar 2014 → Feb 2016 | postural orthostatic tachycardia syndrome | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT06962007 Comparator | Jul 2025 → Sep 2026 overdue | facial spasm | Wonkwang University Hospital | Recruiting | No outcome recorded |
| — | NCT02573519 Comparator | Oct 2015 → Feb 2019 | diabetes mellitus, diabetic autonomic neuropathy, intestinal motility disease | University of Aarhus | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2015-09-17 | Impax Laboratories, LLC | Regulatory Impax Receives FDA Approval for Generic Version of Mestinon® Timespan® Tablets, 180 mg amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration ( FDA ) has approved generic Mestinon Timespan Tablets (pyridostigmine bromide extended release), 180 mg. |
| 2003-04-28 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Approval for Generic Mestinon amneal.com ↗
April 28, 2003--IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Mestinon® (Pyridostigmine Bromide) 60 mg. tablets. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-09-17 | Impax Laboratories, LLC | Impax Receives FDA Approval for Generic Version of Mestinon® Timespan® Tablets, 180 mg amneal.com ↗ |
| 2003-04-28 | Impax Laboratories, LLC | IMPAX Receives FDA Approval for Generic Mestinon amneal.com ↗ |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pyridostigmine | “A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study Comparing the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release and...” NCT07154095 ↗34“Randomized to either the control (pyridostigmine+ placebo) or the test group (pyridostigmine + ondansetron) and treated for 6 weeks.” NCT04226170 ↗ |
| Known as | Bromure de pyridostigmine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Bromuro de piridostigmina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Kalimin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Kalymin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Mestinon | “pilot study using pyridostigmine (Mestinon®), an acetylcholinesterase inhibitor (ACh-E), in HIV-infected patients.” NCT03312244 ↗2“Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis” NCT03510546 ↗ “Pyridostigmine (Mestinon) will be assigned to patients in this arm.” NCT05110417 ↗ |
| Known as | Mestinon 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Mestinon ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | NSC-679759 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | NSC-758435 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | PDG | “Pyridostigmine (PDG), an ACh-esterase inhibitor, increases the half-life of endogenous ACh, therefore mimicking the CAP.” PMID 29093707 ↗ Oct 2017 |
| Known as | pyridostigmine bromide | “METHODS: A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O....” PMID 33066761 ↗ Oct 202010“the study drug, pyridostigmine bromide (60 mg) will be administered at the 30 minute time point.” NCT02307526 ↗ “Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose” NCT03674541 ↗ “Drug: Pyridostigmine Bromide 60 Milligrams (mg)” NCT05110417 ↗ “Drug: Pyridostigmine Bromide” NCT03312244 ↗ “Drug: Pyridostigmine Bromide” NCT02227823 ↗ “Drug: Pyridostigmine Bromide” NCT05603715 ↗ |
| Known as | Pyridostigmine cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Pyridostigmine ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Pyridostigmini bromidum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Regonal | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | Regonol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Known as | RO-1-5130 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1115 ↗ |
| Action | Inhibit | “The cholinesterase inhibitor pyridostigmine” PMID 39727053 ↗ Dec 20241“Acetylcholinesterase inhibitor” CHEMBL1115 ↗ |
| Modality | Small molecule | — CHEMBL1115 ↗ |
| Route | Oral | “Patients will be taking oral Pyridostigmine 30mg tid” NCT00518154 ↗ |
| Target | ACHE | “Acetylcholinesterase inhibitor” CHEMBL1115 ↗ |