loratadine
Trade name: claritin
Approved
Apr 12, 1993
Loratadine is a derivative of azatadine and a second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (histamine H1 antagonists) it lacks central nervous system depressing effects such as drowsiness. Loratadine competes with free histamine and exhibits specific, selective peripheral H1 antagonistic activity. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine. Loratadine has low affinity for cholinergic receptors and does not exhibit any appreciable alpha-adrenergic blocking activity in-vitro. Loratadine also appears to suppress the release of histamine and leukotrienes from animal mast cells, and the release of leukotrienes from human lung fragments, although the clinical importance of this is unknown. — NCATS
Clinical trial activity
75 trials · 60 clinical orgs · 30 marketing orgs
Earliest trial started Mar 1, 1995 (NCT03855228)
Timeline
1990s
2000s
- Dec 19, 2002
GlaxoSmithKline — Marketing Organization
- Dec 19, 2002
Consumer Health Foundation — Marketing Organization
- Dec 19, 2002
Pfizer — NDA Secondary Org
- Dec 19, 2002
Consumer Health Foundation — NDA Secondary Org
- Jan 30, 2003
Perrigo — Marketing Organization
- Feb 21, 2003
P&L Development — Marketing Organization
- Feb 21, 2003
Actavis — Marketing Organization
- Aug 20, 2003
Mylan — Marketing Organization
- Nov 7, 2003
Teva — Marketing Organization
- Jan 28, 2004
Heritage Pharma — Marketing Organization
- Jun 24, 2004
Perrigo — NDA Secondary Org
- Aug 20, 2004
Wockhardt — Marketing Organization
- Aug 20, 2004
Taro Pharmaceuticals — NDA Secondary Org
- Aug 20, 2004
Ranbaxy — Marketing Organization
- Oct 5, 2004
Pharmaceutical Associates — Marketing Organization
- Oct 5, 2004
Apotex — Marketing Organization
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Jun 29, 2006
Lannett Company, Inc. — Marketing Organization
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
2010s
- Jul 31, 2015
Taro Pharmaceuticals — Marketing Organization
- Sep 23, 2016
Marksans Pharma — Marketing Organization
- Apr 11, 2018
Aurobindo Pharma — Marketing Organization
- Apr 16, 2018
Sun Pharmaceuticals — Marketing Organization
- Dec 21, 2018
Bionpharma Inc — Marketing Organization
- Mar 12, 2019
NewGenPharm Inc. — Marketing Organization
- Mar 12, 2019
Guardian Drug — Marketing Organization
- Mar 12, 2019
Appco Pharma — Marketing Organization
- Dec 23, 2019
Granules India — Marketing Organization
2020s
- Jan 15, 2020
Strides Pharma Science — Marketing Organization
- Sep 10, 2020
Rubicon Research — Marketing Organization
- Sep 18, 2020
Tenshi Kaizen — Marketing Organization
- Jan 7, 2021
Unique Pharmaceuticals Ltd, India — Marketing Organization
- May 7, 2021
Hetero Labs Ltd — Marketing Organization
Indications
Approved for
Studied for
- Arthritis, Rheumatoid · Phase 1
- Asthma · Phase 3
- Back Pain · Phase 2
- Breast Neoplasms · Phase 2
- Chronic Urticaria · Phase 4
- Common Cold · Phase 3
- Conjunctivitis · Phase 3
- Conjunctivitis, Allergic · Phase 4
- COVID-19 · Phase 2/Phase 3
- Dermatitis, Atopic · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Eosinophilic Esophagitis · Phase 2
- Healthy Volunteers · Phase 4
- Heat Stress Disorders · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 2
- Histamine H1 Antagonists, Non-Sedating · Phase 1
- Kidney Transplantation · Phase 2
- Lymphangioleiomyomatosis · Phase 2
- Lymphoma · Early Phase 1
- Multiple Myeloma · Phase 4
- Multiple Sclerosis · Phase 1
- Pain · Phase 2
- Pharmacology, Clinical · Phase 1
- Pruritus · Phase 4
- Psoriasis · Phase 1
- Quality of Life · Phase 2
- Renal Insufficiency, Chronic · Phase 4
- Rhinitis · Phase 4
- Rhinitis, Allergic · Phase 4
- Rhinitis, Allergic, Perennial · Phase 4
- Sweat Gland Diseases · Phase 4
- Uremia · Phase 4
Mechanism of action
- Histamine H1 receptorANTAGONIST
HRH1 antagonist
Combination products
claritin
with pseudoephedrine
Also known as claritin-d 24 hour
Approval history
- approvedApr 12, 1993
Chemistry & pharmacology
SMILES
CCOC(=O)N1CCC(CC1)=C2C3=CC=C(Cl)C=C3CCC4=C2N=CC=C4- Mol. weight
- 382.883 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Over the Counter
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaLoratadine ↗
- NCATS7AJO3BO7QN ↗
- ChEMBLCHEMBL998 ↗
Also known as
- alavert
- alavert
- children's claritin
- children's claritin
- claritin
- claritin
- claritin
- claritin
- claritin
- claritin-d
- claritin-d
- claritin hives relief
- claritin hives relief
- claritin hives relief reditab
- claritin hives relief reditab
- claritin reditabs
- claritin reditabs
- clarityn
- clarityn
- clarityne
- clarityne
- clarityn rapide
- hay-rite
- loracert
- loradex
- loratadina
- loratadina
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine
- loratadine redidose
- loratadine redidose
- loratadinum
- loratadinum
- loratidine
- loratyne
- roletra
- roletra
- sch-29851
- sch-29851
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07101445 | Phase 4 | Sep 24, 2025 | Emory University, Gamida Cell, National Cancer Institute (NCI) |
| NCT06955741 | Phase 1 | May 5, 2025 | Bristol-Myers Squibb |
| NCT07300735 | N/A | Mar 1, 2025 | Alexandria University |
| NCT06396013 | Phase 1 | Jun 1, 2024 | Capital Medical University |
| NCT06531707 | Phase 3 | May 20, 2024 | Laboratorios Silanes S.A. de C.V., Mérida Investigación Clínica |
| NCT06250400 | Phase 4 | Mar 31, 2024 | Hangzhou Grand Biologic Pharmaceutical, Inc. |
| NCT06265077 | Phase 1/Phase 2 (Phase 2) | Feb 29, 2024 | Mansoura University |
| NCT06217367 | Phase 4 | Dec 5, 2023 | Lakehead University |
| NCT05421416 | Phase 2 | Nov 1, 2022 | University of Calgary |
| NCT05750875 | Phase 4 | May 1, 2022 | King Edward Medical University |
| NCT05318157 | Phase 4 | Mar 31, 2022 | Capital Medical University, Peking University |
| NCT05243706 | Phase 3 | Mar 1, 2022 | Ain Shams University |
| NCT05265910 | Phase 4 | Dec 14, 2021 | Andover Research Eye Institute |
| NCT05190627 | Phase 2 | Nov 1, 2021 | University of Barcelona |
| NCT05043350 | Phase 2/Phase 3 (Phase 3) | Sep 13, 2021 | Ain Shams University, Nasr City Insurance Hospital |
| NCT04248712 | Phase 2 | Feb 20, 2020 | Mayo Clinic |
| NCT04211259 | Early Phase 1 (Phase 1) | Jan 15, 2020 | National Cancer Institute (NCI), Rutgers University |
| NCT04162795 | Phase 4 | Nov 12, 2019 | Bayer |
| NCT03883386 | Phase 2 | May 31, 2019 | University of Michigan |
| NCT03517943 | Phase 1 | Apr 24, 2018 | Bayer |
Organizations
Research & Development (60)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 14 | 14 | 3 | 1995 |
| Bayer | For profit | 9 | 9 | 4 | 2007 |
| Ranbaxy | For profit | 4 | 4 | 1 | 2002 |
| EMS S/A | For profit | 3 | 2 | 1 | 2011 |
| Johnson and Johnson | For profit | 3 | 3 | 2 | 2001 |
| Sanofi | For profit | 3 | 2 | 2 | 2007 |
| Thammasat University | Academic/Hospital | 3 | 2 | 1 | 2015 |
| Ain Shams University | Academic/Hospital | 2 | 2 | 1 | 2021 |
| ALK-Abello, S.A. | For profit | 2 | 2 | 1 | 2007 |
| Amgen | For profit | 2 | 1 | 2 | 2012 |
| Azidus | For profit | 2 | 2 | 1 | 2010 |
| Capital Medical University | Academic/Hospital | 2 | 2 | 2 | 2022 |
| National Cancer Institute (NCI) | Government | 2 | 0 | 2 | 2020 |
| Alexandria University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Andover Research Eye Institute | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Bristol-Myers Squibb | For profit | 1 | 1 | 1 | 2025 |
| Cancer and Leukemia Group B (CALGB) | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Case Western Reserve University | Academic/Hospital | 1 | 0 | 1 | 2015 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2015 |
Marketing (40)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Feb 21, 2003 |
| Apotex | For profit | MKTG | Oct 5, 2004 |
| Appco Pharma | For profit | MKTG | Mar 12, 2019 |
| Aurobindo Pharma | For profit | MKTG | Apr 11, 2018 |
| Aurobindo Pharma | For profit | SYN | Mar 24, 2023 |
| Bayer | For profit | NDA2 | Apr 12, 1993 |
| Bionpharma Inc | For profit | MKTG | Dec 21, 2018 |
| Bionpharma Inc | For profit | SYN | Dec 21, 2018 |
| Consumer Health Foundation | Academic/Hospital | MKTG | Dec 19, 2002 |
| Consumer Health Foundation | Academic/Hospital | NDA2 | Dec 19, 2002 |
| GlaxoSmithKline | For profit | MKTG | Dec 19, 2002 |
| Granules India | For profit | MKTG | Dec 23, 2019 |
| Granules India | For profit | MKTG | Dec 23, 2019 |
| Guardian Drug | For profit | MKTG | Mar 12, 2019 |
| Heritage Pharma | For profit | MKTG | Jan 28, 2004 |
| Hetero Labs Ltd | For profit | MKTG | May 7, 2021 |
| Hetero Labs Ltd | For profit | SYN | Jul 28, 2023 |
| Lannett Company, Inc. | For profit | MKTG | Jun 29, 2006 |
| Marksans Pharma | For profit | MKTG | Sep 23, 2016 |
| Mylan | For profit | MKTG | Aug 20, 2003 |
| NewGenPharm Inc. | For profit | MKTG | Mar 12, 2019 |
| P&L Development | For profit | MKTG | Feb 21, 2003 |
| Perrigo | For profit | NDA2 | Jun 24, 2004 |
| Perrigo | For profit | MKTG | Jan 30, 2003 |
| Perrigo | For profit | SYN | Jan 21, 2003 |
| Pfizer | For profit | NDA2 | Dec 19, 2002 |
| Pharmaceutical Associates | For profit | MKTG | Oct 5, 2004 |
| Ranbaxy | For profit | MKTG | Aug 20, 2004 |
| Rubicon Research | For profit | MKTG | Sep 10, 2020 |
| Schering-Plough | For profit | NDA | — |
| Strides Pharma Science | For profit | MKTG | Jan 15, 2020 |
| Sun Pharmaceuticals | For profit | SYN | Apr 16, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 16, 2018 |
| Sun Pharmaceuticals | For profit | SYN | Aug 18, 2003 |
| Taro Pharmaceuticals | For profit | NDA2 | Aug 20, 2004 |
| Taro Pharmaceuticals | For profit | MKTG | Jul 31, 2015 |
| Tenshi Kaizen | For profit | MKTG | Sep 18, 2020 |
| Teva | For profit | MKTG | Nov 7, 2003 |
| Unique Pharmaceuticals Ltd, India | For profit | MKTG | Jan 7, 2021 |
| Wockhardt | For profit | MKTG | Aug 20, 2004 |