hydroxyzine
Trade name: vistaril
Approved
Apr 12, 1956
Hydroxyzine, a piperazine antihistamine structurally related to buclizine, cyclizine, and meclizine, is used to treat histamine-mediated pruritus or pruritus due to allergy, nausea and vomiting, and, in combination with an opiate agonist, anxiolytic pain. Hydroxyzine is also used as a perioperative sedative and anxiolytic and to manage acute alcohol withdrawal. Hydroxyzine competes with histamine for binding at H1-receptor sites on the effector cell surface, resulting in suppression of histaminic edema, flare, and pruritus. The sedative properties of hydroxyzine occur at the subcortical level of the CNS. Secondary to its central anticholinergic actions, hydroxyzine may be effective as an antiemetic. It is used for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. — NCATS
Clinical trial activity
20 trials · 25 clinical orgs · 64 marketing orgs
Earliest trial started May 1, 2005 (NCT00162786)
Timeline
1970s
- Aug 24, 1979
Baxalta — Marketing Organization
- Aug 24, 1979
Baxter — Marketing Organization
- Sep 5, 1979
Hospira — Marketing Organization
- Oct 5, 1979
Watson Pharmaceuticals — Marketing Organization
- Oct 5, 1979
Dr. Reddy's Laboratories — Marketing Organization
1980s
- Jun 27, 1980
Organon — Marketing Organization
- Jul 17, 1980
STI Pharma, LLC — Marketing Organization
- Jul 17, 1980
Animas Corporation — Marketing Organization
- Apr 3, 1981
Ivax — Marketing Organization
- Aug 11, 1981
Fresenius — Marketing Organization
- Aug 27, 1981
Lutipold — Marketing Organization
- Aug 27, 1981
Sankyo — Marketing Organization
- Dec 14, 1981
Sandoz — Marketing Organization
- Jan 22, 1982
Vintage — Marketing Organization
- Jan 22, 1982
Strides Pharma Science — Marketing Organization
- Apr 12, 1982
Wockhardt — Marketing Organization
- Jun 23, 1982
Lumara Health — Marketing Organization
- Dec 20, 1982
Aurobindo Pharma — Marketing Organization
- Apr 18, 1983
Mutual Pharmaceutical — Marketing Organization
- Sep 19, 1983
Vanguard — Marketing Organization
- Feb 29, 1984
Duramed Research — Marketing Organization
- Jun 15, 1984
Barr Laboratories — Marketing Organization
- Dec 5, 1984
Superpharm — Marketing Organization
- Mar 4, 1985
Teva — Marketing Organization
- Jan 10, 1986
Pliva — Marketing Organization
- May 2, 1988
Halsey — Marketing Organization
1990s
- Jun 28, 1991
Beximco — Marketing Organization
- Oct 28, 1994
Hi Tech Pharmaceuticals — Marketing Organization
- Oct 28, 1994
Akorn, Inc. — Marketing Organization
- Jul 15, 1996
Impax Laboratories — Marketing Organization
2000s
- Apr 10, 2002
Pharmaceutical Associates — Marketing Organization
- Jul 22, 2004
Able Laboratories — Marketing Organization
- Dec 28, 2004
Epic Pharma Llc — Marketing Organization
- May 27, 2005
Prinston Inc — Marketing Organization
- Mar 20, 2007
Kvk Tech Inc — Marketing Organization
- Mar 12, 2008
Invagen Pharms — Marketing Organization
- Mar 31, 2008
Northstar Healthcare — Marketing Organization
- May 29, 2008
Hetero Labs Ltd — Marketing Organization
- Jun 10, 2008
Sun Pharmaceuticals — Marketing Organization
- Jun 30, 2008
Eci Pharmaceuticals Llc — Marketing Organization
- Jun 30, 2008
Aderis — Marketing Organization
- Jun 30, 2008
TTY Biopharm — Marketing Organization
- Jun 30, 2008
Chartwell Pharmaceuticals — Marketing Organization
- Sep 24, 2008
Amneal Pharmaceuticals — Marketing Organization
2010s
- Jun 7, 2010
Mylan — Marketing Organization
- Jun 7, 2010
Rising Pharmaceuticals — Marketing Organization
- Jan 1, 2012
Earliest Phase 2 Sponsor(trial)
- Jun 3, 2013
Heritage Pharma — Marketing Organization
- Jun 3, 2013
Emcure — Marketing Organization
- Aug 21, 2013
Lannett Company, Inc. — Marketing Organization
- Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
- Mar 29, 2017
Nuvo Research Inc. — Marketing Organization
- Feb 26, 2019
Torrent Pharmaceuticals Limited — Marketing Organization
2020s
- Jan 1, 2023
Earliest Phase 1 Sponsor(trial)
- Aug 17, 2023
Graviti Pharmaceuticals — Marketing Organization
Indications
Studied for
- Anxiety · Phase 4
- Anxiety Disorders · Phase 4
- Child Behavior · Phase 3
- Chronic Urticaria · Phase 4
- Dementia · Phase 3
- Dental Caries · Phase 4
- Depression · Phase 3
- Feeding and Eating Disorders · Phase 4
- Healthy Volunteers · Phase 4
- Hydroxyzine · Phase 4
- Meperidine · Phase 4
- Midazolam · Phase 4
- Myeloproliferative Disorders · Phase 3
- Nausea · Phase 4
- Pain · Phase 4
- Panic Disorder · Phase 4
- Pharmacokinetics · Phase 1
- Procedural Sedation · Phase 4
- Pruritus · Phase 4
- Psychological Distress · Phase 4
- Psychophysiologic Disorders · Phase 3
- Schizophrenia · Phase 3
- Sleep Disorders, Intrinsic · Phase 4
- Smoking Cessation · Phase 4
- Vomiting · Phase 4
Mechanism of action
- Histamine H1 receptorANTAGONIST
HRH1 antagonist
Activity against other receptors such as 5HT2A and D2 may underlie efficacy of anxiolytic and antipsychotic effects
Approval history
- approvedApr 12, 1956
Chemistry & pharmacology
SMILES
Cl.Cl.OCCOCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1- Mol. weight
- 447.83 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3186993 ↗
- WikipediaHydroxyzine ↗
- NCATS30S50YM8OG ↗
- ChEMBLCHEMBL896 ↗
- ChEMBLCHEMBL1201007 ↗
- ChEMBLCHEMBL1200467 ↗
Also known as
- atarax
- atarax
- atarax
- hidroxizina
- hidroxizina
- hychotine
- hychotine
- hydroksyzyny
- hydroksyzyny
- hydroxine
- hydroxine
- hydroxizine
- hydroxizine
- hydroxizine
- hydroxizine
- hydroxizine
- hydroxizine
- hydroxizine
- hydroxizine chloride
- hydroxizine chloride
- hydroxizinum
- hydroxizinum
- hydroxycine
- hydroxycine
- hydroxyzin
- hydroxyzin
- hydroxyzin
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine
- hydroxyzine dihydrochloride
- hydroxyzine dihydrochloride
- hydroxyzine hcl
- hydroxyzine hcl
- hydroxyzine hcl
- hydroxyzine hydrochloride
- hydroxyzine hydrochloride
- hydroxyzine hydrochloride
- hydroxyzine hydrochloride
- hydroxyzine pamoate
- hydroxyzine pamoate
- hydroxyzine pamoate
- hydroxyzinum
- hydroxyzinum
- hydroxyzyne
- hy-pam
- hy-pam
- hy-pam 25
- hy-pam 25
- orgatrax
- orgatrax
- tranquizine
- ucerax
- vistaril
- vistaril
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05737511 | Phase 4 | Dec 30, 2023 | Sultan Qaboos University |
| NCT05680584 | Phase 1 | Feb 1, 2023 | Minia University |
| NCT05224167 | N/A | Mar 1, 2022 | Mongi Slim Hospital |
| NCT05492812 | N/A | Jan 1, 2021 | Suleyman Demirel University |
| NCT04184141 | Phase 4 | Dec 1, 2019 | Istanbul Medeniyet University |
| NCT04068948 | Phase 4 | Jun 25, 2019 | University of Washington |
| NCT04188106 | Phase 4 | Jun 10, 2019 | Foundation for a Smoke-Free World, Rose Research Center, LLC |
| NCT03808805 | Phase 3 | Apr 16, 2019 | University of Western Brittany |
| NCT03728894 | Phase 3 | Nov 17, 2018 | Tishreen University |
| NCT03324828 | Phase 4 | Nov 1, 2017 | Universidad Complutense de Madrid |
| NCT02374567 | Phase 3 | Jan 1, 2015 | Gottfried Wilhelm Leibniz Universität Hannover |
| NCT01501591 | N/A | Nov 1, 2012 | King Faisal University |
| NCT01496911 | Phase 4 | Apr 1, 2012 | Royal Netherlands Navy, Utrecht University |
| NCT01675986 | Phase 2 | Feb 7, 2012 | University of Poitiers |
| NCT01372670 | Phase 4 | Jan 1, 2012 | HealthPartners Institute, Park Nicollet |
| NCT01250652 | Phase 4 | Mar 1, 2011 | Association Asthma, Bulgaria, Hoosier Cancer Research Network |
| NCT01151696 | Phase 4 | May 1, 2010 | University of Toulouse |
| NCT00661674 | N/A | Apr 1, 2008 | Stanford University |
| NCT01055236 | Phase 4 | Aug 1, 2007 | Mahidol University |
| NCT00162786 | Phase 4 | May 1, 2005 | J. Uriach and Company, Maastricht University |
Organizations
Research & Development (25)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Association Asthma, Bulgaria | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Foundation for a Smoke-Free World | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2015 |
| HealthPartners Institute | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Hoosier Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Istanbul Medeniyet University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| J. Uriach and Company | For profit | 1 | 1 | 1 | 2005 |
| King Faisal University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Maastricht University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Mahidol University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Minia University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Mongi Slim Hospital | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Park Nicollet | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Rose Research Center, LLC | For profit | 1 | 1 | 1 | 2019 |
| Royal Netherlands Navy | Government | 1 | 0 | 1 | 2012 |
| Stanford University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Suleyman Demirel University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Sultan Qaboos University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Tishreen University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Universidad Complutense de Madrid | Academic/Hospital | 1 | 1 | 1 | 2017 |
Marketing (71)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Able Laboratories | For profit | MKTG | Jul 22, 2004 |
| Actavis | For profit | MKTG | — |
| Aderis | For profit | MKTG | Jun 30, 2008 |
| Akorn, Inc. | For profit | MKTG | Oct 28, 1994 |
| Alpharma | For profit | MKTG | — |
| Altana | For profit | MKTG | — |
| American Home Products | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 24, 2008 |
| Animas Corporation | For profit | MKTG | Jul 17, 1980 |
| Aurobindo Pharma | For profit | SYN | Dec 20, 1982 |
| Aurobindo Pharma | For profit | MKTG | Dec 20, 1982 |
| Barr Laboratories | For profit | MKTG | Jun 15, 1984 |
| Baxalta | For profit | MKTG | Aug 24, 1979 |
| Baxter | For profit | MKTG | Aug 24, 1979 |
| Beximco | For profit | MKTG | Jun 28, 1991 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 30, 2008 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 5, 1979 |
| Duramed Research | For profit | MKTG | Feb 29, 1984 |
| Eci Pharmaceuticals Llc | For profit | MKTG | Jun 30, 2008 |
| Emcure | For profit | MKTG | Jun 3, 2013 |
| Epic Pharma Llc | For profit | MKTG | Dec 28, 2004 |
| Fresenius | For profit | MKTG | Aug 11, 1981 |
| Graviti Pharmaceuticals | For profit | MKTG | Aug 17, 2023 |
| Halsey | For profit | MKTG | May 2, 1988 |
| Heritage Pharma | For profit | MKTG | Jun 3, 2013 |
| Hetero Labs Ltd | For profit | MKTG | May 29, 2008 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Oct 28, 1994 |
| Hospira | For profit | MKTG | Sep 5, 1979 |
| Impax Laboratories | For profit | MKTG | Jul 15, 1996 |
| Invagen Pharms | For profit | MKTG | Mar 12, 2008 |
| Ivax | For profit | MKTG | Apr 3, 1981 |
| Kvk Tech Inc | For profit | MKTG | Mar 20, 2007 |
| Lannett Company, Inc. | For profit | MKTG | Aug 21, 2013 |
| Lumara Health | For profit | MKTG | Jun 23, 1982 |
| Lutipold | For profit | MKTG | Aug 27, 1981 |
| Mutual Pharmaceutical | For profit | MKTG | Apr 18, 1983 |
| Mylan | For profit | MKTG | Jun 7, 2010 |
| Northstar Healthcare | Academic/Hospital | MKTG | Mar 31, 2008 |
| Nuvo Research Inc. | For profit | MKTG | Mar 29, 2017 |
| Nuvo Research Inc. | For profit | SYN | Mar 29, 2017 |
| Organon | For profit | MKTG | Jun 27, 1980 |
| Par Pharmaceuticals | For profit | MKTG | — |
| Pfizer | For profit | SYN | May 31, 1956 |
| Pfizer | For profit | NDA | Apr 12, 1956 |
| Pharmaceutical Associates | For profit | MKTG | Apr 10, 2002 |
| Pharmafair | For profit | MKTG | — |
| Pliva | For profit | MKTG | Jan 10, 1986 |
| Prinston Inc | For profit | MKTG | May 27, 2005 |
| Puracap Pharmaceutical | For profit | MKTG | — |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Rising Pharmaceuticals | For profit | SYN | Jun 7, 2010 |
| Rising Pharmaceuticals | For profit | MKTG | Jun 7, 2010 |
| SOLOPAK | For profit | MKTG | — |
| STI Pharma, LLC | For profit | MKTG | Jul 17, 1980 |
| Sandoz | For profit | MKTG | Dec 14, 1981 |
| Sankyo | For profit | MKTG | Aug 27, 1981 |
| Smith & Nephew | For profit | MKTG | — |
| Strides Pharma Science | For profit | MKTG | Jan 22, 1982 |
| Sun Pharmaceuticals | For profit | MKTG | Jun 10, 2008 |
| Sun Pharmaceuticals | For profit | SYN | Apr 18, 1983 |
| Superpharm | For profit | MKTG | Dec 5, 1984 |
| TTY Biopharm | For profit | MKTG | Jun 30, 2008 |
| Teva | For profit | SYN | Mar 5, 1982 |
| Teva | For profit | MKTG | Mar 4, 1985 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 26, 2019 |
| Upsher-Smith Laboratories | For profit | MKTG | — |
| Vanguard | For profit | MKTG | Sep 19, 1983 |
| Vintage | For profit | MKTG | Jan 22, 1982 |
| Vintage | For profit | SYN | Apr 10, 2002 |
| Watson Pharmaceuticals | For profit | MKTG | Oct 5, 1979 |
| Wockhardt | For profit | MKTG | Apr 12, 1982 |