Drugs / Simethicone
Simethicone
also known as
Espumisan · Gas-X · Air-X · dimethicone · Flatidyl · Gas Relief · polydimethylsiloxane · simethicon · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | IMODIUM MULTI-SYMPTOM RELIEF | — | 1997-06-26 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04368585 | Jul → Aug 2020 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04186936 | Dec 2019 | — | McNeil AB | Completed | No outcome recorded |
| Phase 1 | NCT05109390 | Jul → Oct 2018 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02382640 | Mar → May 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01269671 | Jan 2011 → Jan 2012 | dyspepsia, irritable bowel syndrome | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT02846155 | May → Dec 2016 | stomach disorder | Changhai Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01312038 | Mar 2011 → Jul 2014 | otitis media | University of Pittsburgh | Completed | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06473493 | Jun 2024 → Mar 2025 | portal hypertension | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT02555228 | Aug → Nov 2015 | stomach disorder | Changi General Hospital | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05801055 | Apr → Jun 2023 | stomach disorder | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT03429621 | Mar 2018 → Feb 2019 | female infertility | Chiang Mai University | Completed | No outcome recorded |
| Phase 3 | NCT02604576 | Jan 2017 → Mar 2018 | dyspepsia | EMS | Completed | No outcome recorded |
| Phase 3 | NCT03009604 | Jan → Apr 2017 | benign female reproductive system neoplasm | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT02340481 | Jul 2005 → May 2006 | diarrheal disease | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 413 trials · 1 missed | ||||||
| Phase 4 | NCT07461389 | Oct 2025 → Apr 2026 | intestinal motility disease | CMH Lahore Medical College and Institute of Dentistry | Completed | No outcome recorded |
| Phase 4 | NCT06919120 | Jun 2025 → Mar 2027 expected | — | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06812832 | Apr 2025 → Mar 2028 expected | — | Madigan Army Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05570669 | May → Dec 2021 | — | Italian Society of Digestive Endoscopy | Completed | No outcome recorded |
| Phase 4 | NCT04145856 | Sep 2018 → May 2019 | irritable bowel syndrome | Hospital Juarez de Mexico | Completed | No outcome recorded |
| Phase 4 | NCT03490396 | May 2018 → Nov 2019 | chemotherapy-induced oral mucositis | Midatech Pharma US Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03157791 | Jul → Nov 2017 | — | University of Manitoba | Completed | No outcome recorded |
| Phase 4 | NCT03119168 | Mar 2017 → Apr 2019 | colon adenoma | Texas Tech University Health Sciences Center, El Paso | Completed | No outcome recorded |
| Phase 4 | NCT02334631 | Jan 2017 → Aug 2019 | small intestine disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | Missed primary |
| Phase 4 | NCT02161367 | Oct 2014 → Jul 2015 | ileus | McMaster University | Completed | No outcome recorded |
| Phase 4 | NCT01653171 | Jul 2012 → Oct 2013 | gastric neoplasm | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 4 | NCT00685607 | Oct 2008 | acute diarrhea | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 4 | NCT01783782 | Nov 2005 → Aug 2013 | — | Azienda Policlinico Umberto I | Unknown | No outcome recorded |
| Phase not applicable8 trials · 3 met primary · 1 missed | ||||||
| — | NCT07674160 | Aug 2026 → May 2028 expected | — | Dalin Tzu Chi General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06581783 | Dec 2024 → Feb 2025 | — | Asian Institute of Gastroenterology, India | Completed | Met primary |
| — | NCT05951712 | Jun → Aug 2022 | mucositis | Asian Institute of Gastroenterology, India | Completed | No outcome recorded |
| — | NCT03166605 | May 2017 → Mar 2019 | — | Albany Medical College | Unknown | No outcome recorded |
| — | NCT03146052 | Mar → May 2017 | polyp | ASST Rhodense | Completed | Met primary |
| — | NCT02967094 | Nov 2016 → Mar 2017 | gastric cancer | Vitkovice Hospital | Unknown | Missed primary |
| — | NCT02540239 | Jan 2015 → Feb 2016 | adenoma | Changhai Hospital | Completed | Met primary |
| — | NCT01790139 | Feb → Nov 2013 | colorectal neoplasm | Asan Medical Center | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 1 | NCT01243736 Comparator | Apr 2010 → Nov 2013 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT07245095 Comparator | Sep 2025 → Nov 2026 expected | Helicobacter pylori infectious disease, gastric neoplasm, upper digestive tract disorder | Hospital General de Mexicali | Recruiting | No outcome recorded |
| Phase 2 | NCT06503978 Background | Aug 2024 → Jul 2025 overdue | autism spectrum disorder, constipation disorder, diarrheal disease | Gut-Brain-Axis Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06321796 Background | Feb 2024 → Feb 2025 | Pitt-Hopkins syndrome | Gut-Brain-Axis Therapeutics Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04487834 Comparator | Apr → Jun 2020 | — | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | Completed | No outcome recorded |
| Phase 2 | NCT03467334 Comparator | May 2017 → Jun 2019 | — | Mónica Olivares Martín; PhD | Completed | No outcome recorded |
| Phase 2/3 | NCT06470386 Background | Jun 2024 → Nov 2025 | portal hypertension | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05175131 Comparator | Nov 2020 → May 2021 | bowel dysfunction | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT03410524 Comparator | Jan → Oct 2018 | — | University of Nevada, Reno | Completed | No outcome recorded |
| Phase 3 | NCT02660372 Comparator | Feb → Oct 2016 | dyspepsia | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 3 | NCT02548403 Comparator | Jul → Sep 2014 | colorectal cancer | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01275560 Comparator | Jan 2011 → Jun 2015 | anus disorder | University Hospital, Rouen | Completed | Met primary |
| Phase 4 | NCT02357303 Comparator | Apr → Dec 2015 | stomach disorder | Portuguese Oncology Institute, Coimbra | Completed | No outcome recorded |
| Phase 4 | NCT02984176 Comparator | Aug 2014 → Jul 2015 | — | Woman's Health University Hospital, Egypt | Completed | No outcome recorded |
| Phase 4 | NCT02217982 Comparator | Jul 2014 → Jun 2015 | relapsing-remitting multiple sclerosis | Rocky Mountain MS Research Group, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02708238 Comparator | Apr 2014 → Jul 2015 | — | Federico II University | Completed | No outcome recorded |
| Phase 4 | NCT00615303 Comparator | Dec 2006 → Dec 2007 | — | Ramathibodi Hospital | Completed | No outcome recorded |
| — | NCT07501962 Comparator | Apr → Dec 2026 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| — | NCT07328880 Comparator | Apr 2025 → Apr 2026 overdue | — | Tanta University | Recruiting | No outcome recorded |
| — | NCT05100719 Comparator | Sep 2022 → Sep 2026 overdue | irritable bowel syndrome, lactose intolerance | University of Pecs | Not yet recruiting | No outcome recorded |
| — | NCT04666324 Comparator | Dec 2020 → Jun 2021 | — | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | Unknown | No outcome recorded |
| — | NCT03816774 Comparator | Jun 2019 → Sep 2022 | colonic neoplasm, colorectal cancer | Portuguese Oncology Institute, Coimbra | Completed | No outcome recorded |
| — | NCT02523911 Comparator | Mar 2016 → Dec 2017 | colorectal cancer | MercyOne Des Moines Medical Center | Withdrawn | No outcome recorded |
| — | NCT01209806 Comparator | Nov 2009 → Aug 2012 | — | Thomas Jefferson University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-12-06 | Jemincare | Regulatory 济民可信西甲硅油乳剂获批上市 jemincare.com ↗
济民可信集团旗下浙江康莱特药业有限公司（以下简称 “康莱特药业”）收到国家药品监督管理局核准签发的《药品注册证书》，批准公司西甲硅油乳剂（规格 40mg/ml ）上市销售，获批日期为 1 1 月 2 8日。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-12-06 | Jemincare | 济民可信西甲硅油乳剂获批上市 jemincare.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simethicone | “The aims of our study were to assess the efficacy of metronidazole in a select population of patients with flatus incontinence associated with SIBO and to compare its efficacy...” PMID 28763464 ↗ Aug 201759“Compound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB...” NCT06473493 ↗ “Alverine Group: Compound Alverine Citrate Capsules (Lejiansu; each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB...” NCT06470386 ↗ “Simethicone (polydimethylsiloxane or dimethicone + SiO2) is an anti-foaming surface-acting agent, which acts by reducing the surface tension of air bubbles, surface viscosity,...” NCT05801055 ↗ “Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion” NCT01783782 ↗ “Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent” NCT02382640 ↗ “with mucolytic solution (100 mL water + 400 mg N-acetylcysteine + 20 mg simethicone), without the solution , and with 100 mL pure water.” PMID 34158672 ↗ Jun 2021 “Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash” NCT03490396 ↗ “Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06321796 ↗ “Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06503978 ↗ “drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;” NCT01243736 ↗ |
| Known as | Air-X | “Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery” NCT03429621 ↗ |
| Known as | dimethicone | “Simethicone (polydimethylsiloxane or dimethicone + SiO2) is an anti-foaming surface-acting agent, which acts by reducing the surface tension of air bubbles, surface viscosity,...” NCT05801055 ↗ |
| Known as | Espumisan | “the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy...” NCT02846155 ↗2“Versus Duspatalin® (Mebeverine) and Versus Espumisan® (Simethicone) in Patients With Functional Bowel Disorders With Abdominal Pain and Excess Gas Formation” NCT05175131 ↗ “Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks.” NCT04666324 ↗ |
| Known as | Flatidyl | “with simethicone (Flatidyl) 4 tablets” NCT07328880 ↗ |
| Known as | Gas Relief | “Simethicone (more commonly known as Gas Relief or Gas-X) relieves pressure, bloating, and fullness commonly referred to as gas.” NCT06812832 ↗ |
| Known as | Gas-X | “simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric...” NCT06812832 ↗2“Simethicone, available over-the-counter under several brand names including Gas-X, may help break up the bubbles that may block the opening of the Eustachian tube in the back...” NCT01312038 ↗ “No studies have been done where simethicone (Gas-X) is ingested after capsule swallowing.” NCT03166605 ↗ |
| Known as | polydimethylsiloxane | “Simethicone (polydimethylsiloxane or dimethicone + SiO2) is an anti-foaming surface-acting agent, which acts by reducing the surface tension of air bubbles, surface viscosity,...” NCT05801055 ↗ |
| Known as | simethicon | “Drug: simethicon” NCT01783782 ↗ |
| Known as | Simethicone manufactured by Taejoon Pharm Co., Ltd. | “Simethicone manufactured by Taejoon Pharm Co., Ltd.” NCT01790139 ↗ |
| Known as | simethocone | “Evaluation of gastric visibility following the combination drink of N-acetyle cysteine and simethocone” NCT05801055 ↗ |
| Modality | Other / unclassified | “defoaming agents such as Simethicone” NCT02357303 ↗ |
| Route | Oral | “administered orally with 4-8 oz. of water” NCT00685607 ↗ |