meclizine
Trade name: antivert
Approved
Feb 14, 1957
Meclizine, a piperazine-derivative H1-receptor antagonist similar to buclizine, cyclizine, and hydroxyzine, is used as an antivertigo/antiemetic agent. Meclizine is used in the management of nausea, vomiting, and dizziness associated with motion sickness and vertigo in diseases affecting the vestibular apparatus. Along with its actions as an antagonist at H1-receptors, meclizine also possesses anticholinergic, central nervous system depressant, and local anesthetic effects. Meclizine depresses labyrinth excitability and vestibular stimulation and may affect the medullary chemoreceptor trigger zone. It is sold under the brand names Bonine, Bonamine, Antivert, Postafen, Sea Legs, and Dramamine II. — NCATS
Clinical trial activity
9 trials · 11 clinical orgs · 36 marketing orgs
Earliest trial started Nov 1, 2006 (NCT00641797)
Timeline
1950s
- Feb 14, 1957
Pfizer — Earliest FDA Approval
- Feb 14, 1957
Pfizer — NDA Organization
- Feb 14, 1957
Casper Pharma LLC — NDA Secondary Org
1970s
- Mar 19, 1975
Invatech — Marketing Organization
- Mar 19, 1975
Sandoz — Marketing Organization
- Mar 19, 1975
Allied Pharmaceutical Services — Marketing Organization
- Dec 1, 1975
Ani Pharmaceuticals — Marketing Organization
- Dec 5, 1975
Teva — Marketing Organization
- Nov 11, 1976
Watson Pharmaceuticals — Marketing Organization
- Feb 7, 1977
AmerisourceBergen — Marketing Organization
- Jun 3, 1977
Lumara Health — Marketing Organization
- May 31, 1978
Anabolic Pharma — Marketing Organization
- Jul 12, 1978
Bundy — Marketing Organization
- Sep 14, 1978
Nexgen Pharma, Inc — Marketing Organization
1980s
- Jun 3, 1981
Apnar Pharma — Marketing Organization
- Jun 3, 1981
Par Pharmaceuticals — Marketing Organization
- Jun 3, 1981
Aurobindo Pharma — Marketing Organization
- Jun 3, 1981
Annora Pharma — Marketing Organization
- Jan 4, 1982
Vanguard — Marketing Organization
- Aug 20, 1985
Superpharm — Marketing Organization
- Dec 11, 1985
Pliva — Marketing Organization
- Mar 31, 1988
Strides Pharma Science — Marketing Organization
1990s
- Jan 30, 1997
Rising Pharmaceuticals — Marketing Organization
- Jan 30, 1997
ANDA Repository — Marketing Organization
2010s
- Jun 4, 2010
Jubilant Innovation Ltd. — Marketing Organization
- Jan 1, 2011
Earliest Phase 2 Sponsor(trial)
- Feb 23, 2011
Amneal Pharmaceuticals — Marketing Organization
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
- Apr 13, 2012
Epic Pharma Llc — Marketing Organization
- Sep 17, 2012
Mylan — Marketing Organization
- Jan 1, 2016
Earliest Phase 3 Sponsor(trial)
- Feb 22, 2019
Wilshire Pharmaceuticals — Marketing Organization
- Feb 22, 2019
Indicus Pharma — Marketing Organization
- Feb 22, 2019
Heritage Pharma — Marketing Organization
2020s
- Jun 23, 2020
Zydus Discovery DMCC — Marketing Organization
- Feb 17, 2022
Invagen Pharms — Marketing Organization
- Feb 17, 2022
Cipla — Marketing Organization
- Aug 11, 2022
Lupin — Marketing Organization
- Aug 11, 2022
Chartwell Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Histamine H1 receptorANTAGONIST
HRH1 antagonist
Approval history
- approvedFeb 14, 1957
Chemistry & pharmacology
SMILES
Cc1cccc(CN2CCN(C(c3ccccc3)c3ccc(Cl)cc3)CC2)c1.Cl.Cl.O- Mol. weight
- 481.9 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3989555 ↗
- WikipediaMeclizine ↗
- NCATSHDP7W44CIO ↗
- ChEMBLCHEMBL1623 ↗
- ChEMBLCHEMBL1200590 ↗
Also known as
- ancoloxin
- ancoloxin
- antivert
- antivert
- antivert
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine
- meclizine hcl
- meclizine hcl
- meclizine hcl
- meclizine hydrochloride
- meclizine hydrochloride
- meclizine hydrochloride
- meclizine hydrochloride
- meclozine
- meclozine
- meclozine
- meclozine
- meclozine
- meclozine dihydrochloride
- meclozine hydrochloride
- meclozine hydrochloride
- nevidoxine
- nevidoxine
- sea-legs
- sea-legs
- traveleeze
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04482985 | Phase 4 | Sep 1, 2020 | Israel Defense Force |
| NCT04564144 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2020 | Mansoura University |
| NCT03253289 | Phase 1 | Oct 12, 2017 | Baylor University |
| NCT03270839 | Phase 4 | Jun 1, 2017 | Israel Defense Force |
| NCT02112578 | Phase 3 | Nov 1, 2016 | Apsen Farmaceutica S.A., CCBR Clinical Research |
| NCT02625181 | N/A | Jul 1, 2016 | University of Washington, Vanderbilt University |
| NCT01537471 | Phase 1 | Jan 1, 2012 | Duke University, Wallace H. Coulter Foundation |
| NCT01443858 | Phase 2 | Aug 1, 2011 | Duke University, Philip Morris |
| NCT00641797 | N/A | Nov 1, 2006 | University of South Florida |
Organizations
Research & Development (11)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Duke University | Academic/Hospital | 2 | 2 | 2 | 2011 |
| Israel Defense Force | Government | 2 | 2 | 1 | 2017 |
| Apsen Farmaceutica S.A. | For profit | 1 | 1 | 1 | 2016 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| CCBR Clinical Research | For profit | 1 | 0 | 1 | 2016 |
| Mansoura University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Philip Morris | For profit | 1 | 0 | 1 | 2011 |
| University of South Florida | Academic/Hospital | 1 | 1 | 1 | 2006 |
| University of Washington | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Vanderbilt University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Wallace H. Coulter Foundation | Academic/Hospital | 1 | 0 | 1 | 2012 |
Marketing (40)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Jan 30, 1997 |
| Allied Pharmaceutical Services | For profit | MKTG | Mar 19, 1975 |
| AmerisourceBergen | For profit | MKTG | Feb 7, 1977 |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 23, 2011 |
| Anabolic Pharma | Academic/Hospital | MKTG | May 31, 1978 |
| Ani Pharmaceuticals | For profit | SYN | Dec 1, 1975 |
| Ani Pharmaceuticals | For profit | MKTG | Dec 1, 1975 |
| Annora Pharma | For profit | MKTG | Jun 3, 1981 |
| Apnar Pharma | For profit | MKTG | Jun 3, 1981 |
| Aurobindo Pharma | For profit | SYN | Sep 17, 2012 |
| Aurobindo Pharma | For profit | MKTG | Jun 3, 1981 |
| Bundy | For profit | MKTG | Jul 12, 1978 |
| Casper Pharma LLC | For profit | NDA2 | Feb 14, 1957 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 11, 2022 |
| Cipla | For profit | MKTG | Feb 17, 2022 |
| Epic Pharma Llc | For profit | MKTG | Apr 13, 2012 |
| Heritage Pharma | For profit | MKTG | Feb 22, 2019 |
| Indicus Pharma | For profit | MKTG | Feb 22, 2019 |
| Invagen Pharms | For profit | MKTG | Feb 17, 2022 |
| Invatech | For profit | MKTG | Mar 19, 1975 |
| Jubilant Innovation Ltd. | For profit | MKTG | Jun 4, 2010 |
| Lumara Health | For profit | MKTG | Jun 3, 1977 |
| Lupin | For profit | MKTG | Aug 11, 2022 |
| Mylan | For profit | MKTG | Sep 17, 2012 |
| Nexgen Pharma, Inc | For profit | MKTG | Sep 14, 1978 |
| Par Pharmaceuticals | For profit | MKTG | Jun 3, 1981 |
| Pfizer | For profit | NDA | Feb 14, 1957 |
| Pliva | For profit | MKTG | Dec 11, 1985 |
| Rising Pharmaceuticals | For profit | SYN | Jan 30, 1997 |
| Rising Pharmaceuticals | For profit | MKTG | Jan 30, 1997 |
| Sandoz | For profit | MKTG | Mar 19, 1975 |
| Strides Pharma Science | For profit | MKTG | Mar 31, 1988 |
| Superpharm | For profit | MKTG | Aug 20, 1985 |
| Teva | For profit | MKTG | Dec 5, 1975 |
| UDL Laboratories | For profit | MKTG | — |
| Vanguard | For profit | MKTG | Jan 4, 1982 |
| Watson Pharmaceuticals | For profit | MKTG | Nov 11, 1976 |
| Wilshire Pharmaceuticals | For profit | MKTG | Feb 22, 2019 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 23, 2020 |
| Zydus Discovery DMCC | For profit | SYN | Jun 23, 2020 |