guaifenesin
Approved
Jun 1, 1952
Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions. Guaifenesin is over-the-counter drug for the treatment of cough and common cold. — NCATS
Clinical trial activity
35 trials · 24 clinical orgs · 17 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00000752)
Timeline
1900s
- Feb 5, 1900
Evidence of US Marketing
1950s
- Jun 1, 1952
Earliest FDA Approval
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Jul 12, 2002
Reckitt Benckiser Pharmaceutical — NDA Secondary Org
- Jan 1, 2007
Reckitt Benckiser Pharmaceutical — Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2010
Earliest Phase 3 Sponsor(trial)
- Nov 23, 2011
Perrigo — Marketing Organization
- Nov 14, 2014
Sovereign Pharmaceuticals — Marketing Organization
- Nov 14, 2014
Sovereign Pharmaceuticals — NDA Secondary Org
- May 14, 2015
Mikart — Marketing Organization
- May 14, 2015
Chartwell Pharmaceuticals — NDA Secondary Org
- May 27, 2015
Actavis — Marketing Organization
- May 27, 2015
Allergan PLC (2015) — Marketing Organization
- Mar 17, 2017
Aurobindo Pharma — Marketing Organization
- Sep 6, 2017
Guardian Drug — Marketing Organization
- Dec 29, 2017
Dr. Reddy's Laboratories — Marketing Organization
- Apr 25, 2018
Eci Pharmaceuticals Llc — Marketing Organization
- Apr 25, 2018
Eci Pharmaceuticals Llc — NDA Secondary Org
- Jul 11, 2018
Amneal Pharmaceuticals — Marketing Organization
- Jul 16, 2018
Ohm Laboratories, Inc. — Marketing Organization
2020s
- Apr 28, 2020
Sun Pharmaceuticals — Marketing Organization
- May 8, 2020
Granules India — Marketing Organization
- Aug 21, 2023
Marksans Pharma — Marketing Organization
Indications
Mechanism of action
- Unspecified targetOTHER
Unknown
Combination products
hycofenix
with hydrocodone, pseudoephedrine
mucinex
with pseudoephedrine
mucinex 12hr cold & fever multi-symptom
with naproxen, dextromethorphan
mucinex dm
with dextromethorphan
obredon
with hydrocodone
Also known as flowtuss, xtrelus
Approval history
- approvedJun 1, 1952
- approvedFeb 5, 1900
Chemistry & pharmacology
SMILES
COC1=CC=CC=C1OCC(O)CO- Mol. weight
- 198.2158 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Over the Counter
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaGuaifenesin ↗
- NCATS495W7451VQ ↗
- ChEMBLCHEMBL980 ↗
Also known as
- amonidron
- famel
- famel
- franolyn chesty
- gecolate
- glycerin guaiacolate
- glycerol guaiacolate
- glycerol guaiacolate
- glycerol guaiacolate
- glyceryl guaiacolate
- glyceryl guaiacolate
- glyceryl guaiacolate
- guaiacol glyceryl ether
- guaiacol glyceryl ether
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesin
- guaifenesine
- guaiphenesin
- guaiphenesin
- guaiphenesin
- guaiphenesin
- guaiphenesine
- humabid
- humabid
- hustosil
- hustosil
- liqufruta
- methphenoxydiol
- methphenoxydiol
- mucinex
- mucinex
- mucinex
- mucinex
- myocain
- myocaine
- myoscain
- nirolex for chesty cough decongestant
- robitussin
- robitussin
- tixylix chesty cough
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05843669 | Phase 4 | Jul 6, 2023 | American Health Research |
| NCT03213353 | Phase 1 | Jul 3, 2017 | Johnson and Johnson |
| NCT02656888 | Phase 3 | Jul 1, 2017 | EMS S/A |
| NCT02656914 | Phase 3 | Jul 1, 2017 | EMS S/A |
| NCT02859246 | N/A | Sep 1, 2016 | Harvard University |
| NCT02581397 | Phase 3 | May 1, 2015 | Ache Laboratorios Farmaceuticos S.A. |
| NCT03725085 | Phase 4 | Jan 24, 2015 | Reckitt Benckiser Pharmaceutical |
| NCT03706300 | Phase 1 | Dec 31, 2014 | Dr. Reddy's Laboratories, QPS |
| NCT02572375 | Phase 1 | Oct 1, 2014 | Nexgen Pharma, Inc, Pharmaceutical Research Unit, Jordan |
| NCT02157649 | Phase 1 | Jun 1, 2014 | Nexgen Pharma, Inc |
| NCT03642262 | Phase 1 | Jun 2, 2013 | Reckitt Benckiser Pharmaceutical |
| NCT03649750 | Phase 1 | May 29, 2013 | Reckitt Benckiser Pharmaceutical |
| NCT01257243 | Phase 3 | Feb 1, 2013 | EMS S/A |
| NCT01576809 | Phase 3 | Mar 1, 2012 | Novartis |
| NCT01562548 | N/A | Feb 1, 2012 | GlaxoSmithKline |
| NCT02069665 | N/A | Dec 1, 2011 | Liaoning Hospital of Traditional Chinese Medicine, Peking University |
| NCT03633487 | Phase 1 | Oct 11, 2011 | Reckitt Benckiser Pharmaceutical |
| NCT01537081 | Phase 2/Phase 3 (Phase 3) | Sep 1, 2011 | Reckitt Benckiser Pharmaceutical |
| NCT03633448 | Phase 1 | Jun 18, 2011 | Reckitt Benckiser Pharmaceutical |
| NCT01119534 | Phase 3 | May 1, 2011 | Azidus |
Organizations
Research & Development (24)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Reckitt Benckiser Pharmaceutical | For profit | 14 | 13 | 4 | 2007 |
| EMS S/A | For profit | 3 | 3 | 1 | 2013 |
| Azidus | For profit | 2 | 2 | 1 | 2010 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 1 | 2 | 1999 |
| Nexgen Pharma, Inc | For profit | 2 | 2 | 1 | 2014 |
| Pfizer | For profit | 2 | 1 | 2 | 2010 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 2 | 1 | 2 | 2009 |
| Ache Laboratorios Farmaceuticos S.A. | For profit | 1 | 1 | 1 | 2015 |
| Adams Laboratories | For profit | 1 | 0 | 1 | 1999 |
| Adams Respiratory Therapeutics | For profit | 1 | 1 | 1 | 2007 |
| American Health Research | For profit | 1 | 1 | 1 | 2023 |
| Dr. Reddy's Laboratories | For profit | 1 | 1 | 1 | 2014 |
| GlaxoSmithKline | For profit | 1 | 1 | 1 | 2012 |
| Glaxo Wellcome | For profit | 1 | 0 | 1 | 1999 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Johnson and Johnson | For profit | 1 | 1 | 1 | 2017 |
| Liaoning Hospital of Traditional Chinese Medicine | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Mantecorp Industria Quimica e Farmaceutica Ltd. | For profit | 1 | 1 | 1 | 2010 |
| Novartis | For profit | 1 | 1 | 1 | 2012 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2011 |
Marketing (24)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | May 27, 2015 |
| Adams Respiratory Therapeutics | For profit | NDA | — |
| Allergan PLC (2015) | For profit | MKTG | May 27, 2015 |
| Amneal Pharmaceuticals | For profit | MKTG | Jul 11, 2018 |
| Aurobindo Pharma | For profit | SYN | Mar 17, 2017 |
| Aurobindo Pharma | For profit | MKTG | Mar 17, 2017 |
| Chartwell Pharmaceuticals | For profit | NDA2 | May 14, 2015 |
| Dr. Reddy's Laboratories | For profit | SYN | Dec 29, 2017 |
| Dr. Reddy's Laboratories | For profit | MKTG | Dec 29, 2017 |
| Eci Pharmaceuticals Llc | For profit | MKTG | Apr 25, 2018 |
| Eci Pharmaceuticals Llc | For profit | NDA2 | Apr 25, 2018 |
| Granules India | For profit | SYN | May 8, 2020 |
| Granules India | For profit | MKTG | May 8, 2020 |
| Guardian Drug | For profit | MKTG | Sep 6, 2017 |
| Marksans Pharma | For profit | MKTG | Aug 21, 2023 |
| Mikart | For profit | MKTG | May 14, 2015 |
| Ohm Laboratories, Inc. | For profit | MKTG | Jul 16, 2018 |
| Perrigo | For profit | SYN | Feb 1, 2022 |
| Perrigo | For profit | MKTG | Nov 23, 2011 |
| Reckitt Benckiser Pharmaceutical | For profit | NDA2 | Jul 12, 2002 |
| Sovereign Pharmaceuticals | For profit | MKTG | Nov 14, 2014 |
| Sovereign Pharmaceuticals | For profit | NDA2 | Nov 14, 2014 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 28, 2020 |
| Sun Pharmaceuticals | For profit | SYN | Jul 1, 2021 |