Drugs / Levocetirizine
Levocetirizine
also known as
levocetirizine dihydrochloride · Xyzal · LCTZ · LCT · levocet · Levocetirizine Hydrochloride · LTZ · Zina
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic urticaria 1 milestone | |||||
| Filed | US (FDA) | — | idiopathic urticaria | 2009-06-24 | “today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml” perrigo.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | XYZAL | — | 2009-08-21 | fda.gov ↗ |
| Approved | US (FDA) | XYZAL | — | 2007-05-25 | fda.gov ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 met primary | ||||||
| Phase 1 | NCT03371849 | Jul → Aug 2017 | — | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 1 | NCT01651481 | Jul → Sep 2012 | rhinitis | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01622283 | May → Jun 2012 | allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT02447393 | Mar → Apr 2008 | dermatitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00521170 | Nov 2004 → Jan 2005 | allergic disease | UCB Pharma | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT06632405 | Apr 2025 → Mar 2027 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07857941 | Jan 2025 → Dec 2026 expected | — | Buddhist Tzu Chi General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT01722162 | Apr 2013 → Oct 2015 | colorectal neoplasm | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00291642 | Jan → Apr 2006 | seasonal allergic rhinitis | UCB Pharma | Completed | Met primary |
| Phase 2 | NCT00152412 | Jun → Dec 2004 | allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00520754 | Dec 2001 → Mar 2003 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01392859 | Jun 2011 → Mar 2015 | allergic asthma, intrinsic asthma | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 317 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05637710 | Mar 2026 → May 2027 | allergic rhinitis | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03545464 | Sep 2019 → Feb 2025 | angioedema | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT01640535 | Jun 2012 → Feb 2013 | perennial allergic rhinitis | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT01563081 | Apr → Aug 2012 | allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01509209 | May 2011 → Apr 2013 | vasomotor rhinitis | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT01000792 | Nov 2009 → Jan 2010 | allergic rhinitis | Clinical Research International Limited | Completed | No outcome recorded |
| Phase 3 | NCT00619801 | Mar → Jul 2008 | allergic rhinitis, chronic idiopathic urticaria | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00628108 | Mar → Sep 2008 | allergic rhinitis, chronic idiopathic urticaria | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00315523 | Jul → Oct 2006 | seasonal allergic rhinitis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00375713 | Oct 2005 → May 2006 | dermatitis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00160563 | Jun 2004 → Mar 2006 | asthma | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00544388 | Apr → Jul 2004 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00789152 | Dec 2003 → May 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00524836 | Sep 2003 → Feb 2004 | perennial allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00525382 | Aug 2003 → Mar 2004 | urticaria | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00525278 | Aug → Oct 2003 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00152464 | Mar 2002 → Mar 2006 | atopic eczema | UCB Pharma | Completed | Missed primary |
| Phase 418 trials · 3 met primary · 1 missed | ||||||
| Phase 4 | NCT03590912 | Sep 2018 → Feb 2020 | otitis media with effusion | Lumbini Medical College | Completed | No outcome recorded |
| Phase 4 | NCT01496911 | Apr → Oct 2012 | — | Utrecht Institute for Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01250652 | Mar 2011 → Feb 2013 | chronic urticaria | Association Asthma, Bulgaria | Completed | No outcome recorded |
| Phase 4 | NCT00884325 | Feb 2009 → Jan 2010 | atopic eczema | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT00653224 | Apr → Jul 2008 | seasonal allergic rhinitis | UCB Pharma | Completed | Met primary |
| Phase 4 | NCT00621959 | Mar → Jun 2008 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00439712 | Feb → May 2007 | perennial allergic rhinitis | Institut für Atemwegsforschung GmbH | Completed | No outcome recorded |
| Phase 4 | NCT00295022 | Jul → Oct 2006 | seasonal allergic rhinitis | UCB Pharma | Completed | Met primary |
| Phase 4 | NCT00355771 | Jun 2006 → Nov 2007 | allergic rhinitis | Institut für Atemwegsforschung GmbH | Completed | No outcome recorded |
| Phase 4 | NCT00346606 | Jan 2006 → ? | chronic idiopathic urticaria | Lotus Pharmaceutical | Unknown | No outcome recorded |
| Phase 4 | NCT00264303 | Dec 2005 → Jan 2007 | chronic idiopathic urticaria | UCB Pharma | Completed | Met primary |
| Phase 4 | NCT00679250 | Nov 2005 → Dec 2006 | allergic rhinitis | Brian J Lipworth | Completed | Mixed |
| Phase 4 | NCT00160537 | May → Jul 2005 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00160589 | Apr → Sep 2005 | perennial allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00160680 | Mar 2005 → Jun 2006 | perennial allergic rhinitis | UCB Pharma | Completed | Missed primary |
| Phase 4 | NCT00150761 | Jul → Oct 2004 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00542607 | Sep → Dec 2002 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00521131 | Sep 2002 → May 2003 | perennial allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04399525 | Oct 2019 → Mar 2020 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT00521040 | Feb → Jul 2004 | seasonal allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 1 | NCT05565729 Background | Oct 2022 → Feb 2023 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01491503 Comparator | Nov 2011 → Jan 2012 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 2 | NCT06816784 Comparator | Feb → Jul 2025 overdue | chronic urticaria | Sheikh Zayed Medical College | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05638880 Comparator | Dec 2022 → Dec 2025 | diabetic kidney disease | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2 | NCT00866788 Background | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2/3 | NCT02565680 Background | Feb 2012 → Feb 2014 | urticaria | University Hospital, Toulouse | Completed | Missed primary |
| Phase 3 | NCT04699604 Comparator | Apr 2021 → Apr 2026 | allergic asthma | Bridgette Jones | Completed | No outcome recorded |
| Phase 3 | NCT02372604 Comparator | Jul 2015 → Dec 2016 | chronic urticaria | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 3 | NCT00421109 Comparator | Jul 2006 → Jul 2007 | chronic idiopathic urticaria | Faes Farma, S.A. | Completed | Met primary |
| Phase 4 | NCT07341776 Comparator | Jan → Dec 2026 expected | anaphylaxis, food allergy | Johannes Trueck | Recruiting | No outcome recorded |
| Phase 4 | NCT03789422 Comparator | Dec 2019 → Sep 2022 | chronic urticaria | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 4 | NCT03991845 Background | Jun → Nov 2019 | chronic urticaria, vitamin D deficiency | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT01586091 Comparator | Feb → Nov 2011 | allergic rhinitis, chronic urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT01430260 Comparator | Jan 2011 → Jul 2012 | allergic rhinitis | Handok Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02507635 Comparator | Feb 2009 → Nov 2011 | allergic rhinitis | Iuliu Hatieganu University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 4 | NCT00894231 Comparator | Jan → Aug 2009 | perennial allergic rhinitis | AAADRS Clinical Research Center | Completed | No outcome recorded |
| Phase 4 | NCT00826943 Comparator | Jan → May 2009 | allergic rhinitis | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00359138 Comparator | Feb → May 2006 | hypersensitivity reaction disease | Organon and Co | Completed | No outcome recorded |
| — | NCT05348148 Comparator | Jun 2020 → Mar 2032 expected | vasomotor rhinitis | Camillians Saint Mary's Hospital Luodong | Recruiting | No outcome recorded |
| — | NCT03673384 Background | Mar 2015 → Jul 2017 | allergic rhinitis | Nanhua University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2020-02-17 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. |
| 2018-10-10 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 美 흉부의사협회, 한미약품 몬테리진 3상 결과에 ‘주목’ hanmi.co.kr ↗
연구결과에 따르면, 몬테리진 투여군은 몬테루카스트 단일제 투여군 대비 후반 2주(3~4주차) MDNSS 변화량에서 우월한 효과를 나타냈으며, 이상반응에서도 단일제 대비 유의한 차이를 보이지 않았다. |
| 2018-08-20 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품 ‘몬테리진캡슐’ 임상 3상 결과 SCI급 국제학술지 등재 hanmi.co.kr ↗
연구 결과에 따르면, 몬테리진캡슐 투여군은 몬테루카스트 단일제 투여군 대비 후반 2주(3~4주)차 MDNSS(Mean Daytime Nasal Symptom Score/낮 시간 동안의 코 증상 평균 수치) 변화량에서 우월한 효과를 입증했다. |
| 2017-08-18 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “한미 몬테리진 전국 달군다”…서울 심포지엄 ‘스타트’ hanmi.co.kr ↗
실제로, 한미약품이 천식과 알레르기 비염을 동반한 환자 210명을 대상으로 몬테루카스트 단일제 투약군과 몬테리진 투약군으로 나누어 4주간 비교한 결과, 몬테리진 투여군이 단일제 투여군 대비 후반 2주(3-4주)차 MDNSS(Mean Daytime Nasal Symptom Score, 낮 시간 동안의 코 증상 수치)에서 우월한 효과가 나타났다. |
| 2017-05-17 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한미, 천식+알레르기비염 치료 복합제 세계 첫 허가 hanmi.co.kr ↗
한미약품(대표이사 우종수·권세창)은 천식과 통년성 알레르기비염을 동반한 환자 치료(알레르기비염 증상 개선)에 쓰이는 복합제 ‘몬테리진’ 시판허가를 식품의약품안전처로부터 받았다고 17일 밝혔다. |
| 2011-05-18 | Perrigo Company | Regulatory Perrigo's Partner Synthon Receives FDA Tentative Approval for Levocetirizine Solution - Generic Equivalent to Xyzal® Oral Solution perrigo.com ↗
The tentative approval of Levocetirizine oral solution yet again is proof to Synthon's achievements and our fruitful cooperation with Perrigo. |
| 2010-11-29 | Perrigo Company | Regulatory Perrigo and Synthon Announce FDA Final Approval and the Launch of the Generic Version of Xyzal® perrigo.com ↗
Perrigo (Nasdaq: PRGO;TASE) today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. |
| 2010-10-28 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal gsk.com ↗
The anti-allergic drug, Xyzal, has been approved for the treatment of allergic rhinitis, urticaria, eczema and dermatitis, prurigo, and cutaneous pruritus in patients over the age of seven years. |
| 2009-06-24 | Perrigo Company | Regulatory Perrigo Confirms That its Partner Synthon Has Filed for Generic Version of Xyzal® Solution and Announcement of Lawsuit by Sepracor/UCB perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal® solution 2.5mg/5ml. |
All press releases naming this drug 11 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | levocetirizine | “Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788 ↗63“Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.” NCT00346606 ↗ “Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials.” NCT00826943 ↗ “In addition to levocetirizine (5 mg orally for 5 days), patients were assigned to receive prednisone (40 mg orally for 4 days) or placebo.” PMID 28476259 ↗ May 2017 “Comparator group: Levocetirizine 5mg (Zina® - comparator drug)” NCT05637710 ↗ “Levocetirizine 10 mg once daily will be given to all patients” NCT03991845 ↗ “Levocetirizine” NCT07341776 ↗ |
| Known as | LCT | “Levocetirizine(LCT)” NCT01392859 ↗ |
| Known as | LCTZ | “0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.” NCT00152464 ↗2“5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.” NCT00295022 ↗ “5 mg of Levocetirizine (LCTZ) was taken orally once a day.” NCT00160680 ↗ |
| Known as | levocet | “Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years” NCT03590912 ↗ |
| Known as | levocetirizine dihydrochloride | “Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788 ↗6“Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.” NCT02372604 ↗ “Levocetirizine dihydrochloride/ Xyzal® (UCB, Inc.) immediate release oral solution” NCT04699604 ↗ “The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride).” NCT01000792 ↗ |
| Known as | Levocetirizine Hydrochloride | “A Multi-Center, Open-labelled Study to Evaluate the Safety of Levocetirizine Hydrochloride Oral Solution in Children Aged 6 Months to 2 Years With Allergic Rhinitis or Pruritus...” NCT01563081 ↗ |
| Known as | LTZ | “using Levocetirizine (LTZ) vs placebo” NCT04699604 ↗ |
| Known as | Xyzal | “Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.” NCT00346606 ↗5“The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride).” NCT01000792 ↗ “Levocetirizine dihydrochloride (Xyzal)” NCT00884325 ↗ “levocetirizine (xyzal)” NCT00826943 ↗ |
| Known as | Zina | “Comparator group: Levocetirizine 5mg (Zina® - comparator drug)” NCT05637710 ↗ |
| Action | Inhibit | “used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.” NCT03673384 ↗ |
| Route | Oral | “Single Oral Dose” NCT00150761 ↗ |