Drugs / Guaifenesin
Guaifenesin
also known as
Mucinex · GGE · Amonidron · CVT-2534 · Famel · Franolyn chesty · Gecolate · Glycerol guaiacolate · +23 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2007-09-27 | “Perrigo filed its ANDA for Guaifenesin Extended-Release Tablets, 600 mg containing a Paragraph IV Certification with the U.S. Food & Drug Administration.” perrigo.com ↗ |
| Approved | US (FDA) | MUCINEX | — | 2002-07-12 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT02572375 | Oct → Nov 2014 | — | Nexgen Pharma, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03642262 | Jun → Aug 2013 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03649750 | May → Aug 2013 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03633487 | Oct 2011 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03633448 | Jun → Jul 2011 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03643575 | Jun → Jul 2009 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03644108 | Jun 2009 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00902707 | May 2009 → May 2012 | mucus inspissation of respiratory tract | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT03642873 | May 2007 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01537081 | Sep 2011 → Mar 2012 | respiratory tract infectious disorder | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00857987 | Apr 2010 → Oct 2011 | respiratory tract infectious disorder | Azidus Brasil | Unknown | No outcome recorded |
| Phase 3 | NCT01085721 | — | viral respiratory tract infection | Mantecorp Industria Quimica e Farmaceutica Ltd. | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06716645 | Dec 2024 → Feb 2025 | common cold | HALEON | Completed | No outcome recorded |
| Phase 4 | NCT03725085 | Jan → Oct 2015 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00441246 | Feb → May 2007 | bronchitis, respiratory tract infectious disorder, sinusitis | Adams Respiratory Therapeutics | Completed | No outcome recorded |
| Phase not applicable4 trials · 2 missed | ||||||
| — | NCT07398924 | Jan 2022 → Jun 2023 | anovulation, female infertility | Yuzuncu Yil University | Completed | No outcome recorded |
| — | NCT02859246 | Sep 2016 → Jul 2018 | filamentary keratitis | Massachusetts Eye and Ear Infirmary | Completed | No outcome recorded |
| — | NCT01562548 | Feb 2012 → May 2013 | — | GlaxoSmithKline | Completed | Missed primary |
| — | NCT01062256 | Jan → Feb 2010 | respiratory tract infectious disorder | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT02157649 Comparator | Jun → Aug 2014 | — | Nexgen Pharma, Inc | Completed | No outcome recorded |
| Phase 2 | NCT01364467 Comparator | May 2011 → Mar 2018 | chronic rhinitis | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT01114581 Comparator | Apr 2010 → Apr 2011 | respiratory tract infectious disorder | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01046136 Comparator | Dec 2009 → Mar 2010 | common cold | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00000752 Background | ? → Feb 1993 | HIV infectious disease, sinusitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 3 | NCT02581397 Comparator | May 2015 → Dec 2016 | — | Ache Laboratorios Farmaceuticos S.A. | Terminated | No outcome recorded |
| Phase 3 | NCT01257243 Comparator | Oct 2012 → Sep 2013 | — | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01576809 Background | Mar → May 2012 | respiratory tract infectious disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT01119534 Comparator | May → Oct 2011 | — | Azidus Brasil | Unknown | No outcome recorded |
| Phase 4 | NCT01202279 Comparator | Oct 2009 → Apr 2010 | respiratory tract infectious disorder | Reckitt Benckiser Inc. | Completed | Met primary |
| Phase 4 | NCT00377403 Background | Oct 2006 → May 2009 | respiratory tract infectious disorder, sinusitis | Washington University School of Medicine | Completed | Missed primary |
| — | NCT02069665 Comparator | Dec 2011 → Jul 2013 | pneumonia | Liaoning University of Traditional Chinese Medicine | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-03-07 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex® DM Maximum Strength Extended Release Tablets perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug administration for the store brand OTC equivalent of Mucinex ® DM Maximum Strength (Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets, 1200 mg/60 mg). |
| 2011-11-28 | Perrigo Company | Regulatory Perrigo Receives Final FDA Approval for Store Brand Equivalent to Generic Version of Mucinex® perrigo.com ↗
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg. |
| 2007-09-27 | Perrigo Company | Regulatory Perrigo Confirms Filing for Generic Version of Mucinex® and Announcement of Lawsuit by Adams Respiratory perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it had filed an Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex®. |
All press releases naming this drug 12 releases
Evidence & citations 34 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | guaifenesin | “Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to...” NCT03642873 ↗29“Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and...” NCT03633448 ↗ “Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.” NCT02157649 ↗ “Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.” NCT03642262 ↗ “Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg” NCT06716645 ↗ “Finally, each Transpulmin Syrup contains guaifenesin, which chemically it is a glyceryl ether guaiacol.” NCT02581397 ↗ “Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water” NCT03643575 ↗ “Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet.” NCT01537081 ↗ “Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet” NCT03633487 ↗ “Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.” NCT00857987 ↗ “Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets” NCT01114581 ↗ |
| Known as | Amonidron | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | CVT-2534 | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Famel | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Franolyn chesty | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Gecolate | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | GGE | “Guaifenesin (glyceryl guaiacolate ether [GGE]) has been studied as a cough suppressant and as an expectorant; however, published studies to date have failed to find a...” PMID 24003241 ↗ Sep 20131“Observational studies suggest that orally administered guaifenesin (GGE) may thin lower respiratory tract secretions” PMID 26462765 ↗ Oct 2015 |
| Known as | Glycerol guaiacolate | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | glyceryl ether guaiacol | “Finally, each Transpulmin Syrup contains guaifenesin, which chemically it is a glyceryl ether guaiacol.” NCT02581397 ↗ |
| Known as | Glyceryl guaiacolate | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | glyceryl guaiacolate ether | “Guaifenesin (glyceryl guaiacolate ether [GGE]) has been studied as a cough suppressant and as an expectorant; however, published studies to date have failed to find a...” PMID 24003241 ↗ Sep 2013 |
| Known as | Guaiacol glyceryl ether | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of flowtuss | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of hycofenix | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of mucinex d | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of mucinex dm | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of obredon | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesin component of xtrelus | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesina | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifenesine | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaifensin | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Guaiphenesin | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Humabid | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Humibid | “Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions.” NCT03642873 ↗ |
| Known as | Hustosil | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Liqufruta | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Methphenoxydiol | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Mucinex | “This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE,...” NCT03725085 ↗5“Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and...” NCT03633448 ↗ “Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet.” NCT01537081 ↗ “Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets” NCT01114581 ↗ |
| Known as | Nirolex for chesty cough decongestant | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | NSC-62112 | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Robitussin | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Known as | Tixylix chesty cough | ChEMBL registry synonym — accepted as the source's own label CHEMBL980 ↗ |
| Modality | Small molecule | — CHEMBL980 ↗ |
| Route | Oral | “oral Deconsal II, a drug combining pseudoephedrine, a decongestant, and guaifenesin” NCT00000752 ↗ |