Drugs / Azelastine
Azelastine
also known as
Azelastine hydrochloride · azelastineHcl · Astepro · Astelin · AZE · A-5610 · Astepro allergy · Azelair · +13 more
Small molecule targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ASTEPRO | — | 2013-08-30 – 2015-02-20 | fda.gov ↗ |
| Filed | US (FDA) | — | — | 2012-01-23 | “has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%)” perrigo.com ↗ |
| Label expansions (3) | US (FDA) | ASTELIN | — | 2000-05-30 – 2006-02-17 | fda.gov ↗ |
| Approved | US (FDA) | ASTELIN | — | 1996-11-01 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07635459 | Jul 2026 → Jun 2027 expected | chronic rhinosinusitis | The First Affiliated Hospital of Xinxiang Medical College | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05887843 | Jun → Sep 2023 | seasonal allergic rhinitis | Sandoz | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01194622 | Aug → Oct 2010 | allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04817800 | Mar → Apr 2021 | seasonal allergic rhinitis | Humanis | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06126952 | Oct 2023 → Feb 2024 | seasonal allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 2 | NCT06051786 | Aug 2020 → Jul 2021 | allergic rhinitis | Synmosa Biopharma Corp. | Completed | No outcome recorded |
| Phase 2 | NCT00612118 | Feb → May 2008 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary | ||||||
| Phase 3 | NCT05311475 | Apr 2022 → Jun 2023 | seasonal allergic rhinitis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT04264637 | Feb 2020 → Mar 2021 | allergic rhinitis | Bayer | Completed | Met primary |
| Phase 3 | NCT02249663 | Aug 2014 → Feb 2015 | seasonal allergic rhinitis | Teva Pharmaceuticals USA | Unknown | No outcome recorded |
| Phase 3 | NCT00883168 | Apr → Jul 2009 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00720278 | Aug → Oct 2007 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00720382 | Mar 2007 → Jun 2008 | perennial allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00712920 | Jan 2007 → May 2008 | perennial allergic rhinitis | Meda Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00783432 | Jul 2006 → Dec 2007 | allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT07597473 | May → Oct 2026 expected | allergic rhinitis | Viatris Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06008860 | Jul 2023 → Dec 2026 expected | COVID-19 | University of Chicago | Recruiting | No outcome recorded |
| Phase 4 | NCT07415278 | Dec 2022 → Oct 2023 overdue | allergic rhinitis | Pamukkale University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05080322 | Sep 2021 → Dec 2025 | allergic rhinitis | Zheng Liu ENT | Completed | No outcome recorded |
| Phase 4 | NCT04652245 | Dec 2020 → Dec 2021 | seasonal allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | Met primary |
| Phase 4 | NCT03004131 | Jan → Mar 2017 | seasonal allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 4 | NCT02238353 | Oct 2014 → Dec 2015 | allergic rhinitis, house allergic alveolitis | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
| Phase 4 | NCT00845598 | Aug 2010 → Aug 2011 | allergic rhinitis | University of Dundee | Withdrawn | No outcome recorded |
| Phase 4 | NCT00772304 | Oct → Nov 2008 | allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00561717 | Oct → Dec 2007 | seasonal allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05709977 | Apr → Nov 2023 | allergic rhinitis | Johanna Maria Vermeulen | Completed | No outcome recorded |
| — | NCT00117832 | Mar 2005 → May 2006 | seasonal allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| Comparator or background therapy30 trials | ||||||
| Phase 1 | NCT01190852 Comparator | Aug → Oct 2010 | allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 2 | NCT03444506 Comparator | Jan → Feb 2014 | seasonal allergic rhinitis | Glenmark Pharmaceuticals Ltd. India | Completed | Met primary |
| Phase 2 | NCT00940953 Comparator | Feb → May 2008 | seasonal allergic rhinitis | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01382654 Comparator | Sep → Oct 2006 | allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT06212973 Comparator | Mar → Nov 2023 | conjunctivitis | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05590598 Background | Feb → Jun 2023 | seasonal allergic rhinitis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT04729517 Comparator | Apr 2021 → Mar 2023 | allergic rhinitis | Abdi Ibrahim Ilac San. ve Tic A.S. | Completed | No outcome recorded |
| Phase 3 | NCT03599791 Comparator | Jun 2018 → Sep 2019 | allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | Met primary |
| Phase 3 | NCT02230696 Comparator | Aug 2014 → Feb 2015 | seasonal allergic rhinitis | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT01915823 Comparator | Jul 2013 → Feb 2014 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01794741 Comparator | Feb → Nov 2013 | allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01470053 Comparator | Mar → Dec 2011 | perennial allergic rhinitis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01018862 Comparator | Nov 2009 → Apr 2011 | perennial allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00824473 Comparator | Dec 2008 → Feb 2009 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00740792 Comparator | Aug → Nov 2008 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00651118 Comparator | Mar → Jun 2008 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00660517 Comparator | Dec 2007 → Feb 2008 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00660829 Comparator | Dec 2007 → Feb 2008 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00719862 Comparator | Aug → Nov 2007 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01368445 Comparator | Aug → Nov 2006 | seasonal allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06800274 Comparator | Apr 2023 → Mar 2024 | atopic conjunctivitis, dry eye syndrome | Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | Completed | No outcome recorded |
| Phase 4 | NCT05626621 Comparator | Nov 2022 → Aug 2025 overdue | chronic rhinitis | Endeavor Health | Recruiting | No outcome recorded |
| Phase 4 | NCT04601324 Comparator | Dec 2020 → Jun 2021 | allergic rhinitis | St. Paul's Sinus Centre | Withdrawn | No outcome recorded |
| Phase 4 | NCT02953106 Comparator | Jan 2017 → Sep 2018 | allergic asthma, allergic rhinitis | University of Dundee | Terminated | No outcome recorded |
| Phase 4 | NCT02557269 Background | May → Oct 2015 | seasonal allergic rhinitis | Association Asthma, Bulgaria | Unknown | No outcome recorded |
| Phase 4 | NCT01880840 Comparator | Jun 2013 → Apr 2014 | allergic rhinitis | Meda Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00979615 Comparator | Sep → Nov 2009 | vasomotor rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00845195 Comparator | Mar → May 2009 | seasonal allergic rhinitis | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00806754 Comparator | Nov 2006 → May 2007 | perennial allergic rhinitis | AstraZeneca | Completed | No outcome recorded |
| — | NCT04561687 Comparator | Jan 2020 → Sep 2021 | allergic rhinitis | Shiraz University of Medical Sciences | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2014-05-12 | Perrigo Company | Regulatory Perrigo Company plc Announces FDA Approval Of Generic Version Of Astepro® Nasal Spray perrigo.com ↗
Perrigo Company plc (NYSE: PRGO;TASE) announced that it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%). |
| 2012-05-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Astelin® Nasal Spray sunpharma.com ↗
Sun Pharma announces USFDA approval for generic Astelin® Nasal Spray |
| 2012-01-23 | Perrigo Company | Regulatory Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals perrigo.com ↗
Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) of its filing. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-23 | Sandoz | Sandoz launches azelastine/fluticasone nasal spray in Germany and Switzerland, expanding patient access to high-quality allergy treatment option sandoz.com ↗ |
| 2014-05-12 | Perrigo Company | Perrigo Company plc Announces FDA Approval Of Generic Version Of Astepro® Nasal Spray perrigo.com ↗ |
| 2012-05-24 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Astelin® Nasal Spray sunpharma.com ↗ |
| 2012-01-23 | Perrigo Company | Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals perrigo.com ↗ |
| 2010-06-21 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Optivar® sunpharma.com ↗ |
| 2009-07-02 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA tentative approval for generic Optivar® sunpharma.com ↗ |
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azelastine | “Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID” NCT03444506 ↗46“Astepro (azelastine) is a second generation antihistamine, as well as an anti-inflammatory and mast cell stabilizer8.” NCT06008860 ↗ “Carelastin® (1 mg/ml) azelastine nasal spray” NCT05709977 ↗ “azelastine hydrochloride (AZE)” PMID 29490769 ↗ Mar 2018 |
| Known as | A-5610 | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Astelin | “Astelin Nasal Spray (0.1% azelastine hydrochloride)” NCT00783432 ↗1“Azelastine HCl (Astelin) Nasal Spray, 137 mcg” NCT00979615 ↗ |
| Known as | Astepro | “Astepro (azelastine) is a second generation antihistamine, as well as an anti-inflammatory and mast cell stabilizer8.” NCT06008860 ↗2“Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose)” NCT01880840 ↗ “Astepro Nasal Spray (0.1% azelastine hydrochloride)” NCT00783432 ↗ |
| Known as | Astepro allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | AZE | “Azelastine hydrochloride (AZE) is a selective, non-sedating H1 antagonist with anti-inflammatory and mast cell stabilizing properties” PMID 37920410 ↗ Oct 20231“azelastine hydrochloride (AZE)” PMID 29490769 ↗ Mar 2018 |
| Known as | Azelair | “Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)” NCT06126952 ↗ |
| Known as | Azelastina | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Azelastine hydrochloride | “This randomized, single-blind study aims to compare the efficacy and safety of N-acetyl-aspartyl-glutamate (NAAGA) and azelastine hydrochloride eye drops in patients with...” NCT06800274 ↗24“Fluticasone propionate nasal spray and azelastine hydrochloride nasal spray used in this study have been approved and widely used in AR patients for many years in China.” NCT05080322 ↗ “AFC is a fixed-dose combination product of Azelastine hydrochloride (137mcg), a selective H1-receptor antagonist and, Fluticasone propionate (50mcg), a corticosteroid.” NCT06051786 ↗ “TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray (= US formulation as used in pivotal studies)” NCT01194622 ↗ “Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.” NCT07415278 ↗ “Azelastine hydrochloride (AZE) is a selective, non-sedating H1 antagonist with anti-inflammatory and mast cell stabilizing properties” PMID 37920410 ↗ Oct 2023 “Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril” NCT05887843 ↗ “Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose)” NCT01880840 ↗ “Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)” NCT06126952 ↗ “Drug: azelastine hydrochloride and fluticasone propionate” NCT01915823 ↗ “Astepro Nasal Spray (0.1% azelastine hydrochloride)” NCT00783432 ↗ |
| Known as | Azelastine Hydrochloride BP | “Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination” NCT00845598 ↗ |
| Known as | Azelastine hydrochloride component of dymista | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | azelastineHcl | “CONCLUSION: Azelastine HCl 0.15% nasal spray relieves nasal symptoms associated with allergic rhinitis and has a fast onset of action within 30 minutes.” PMID 39067509 ↗ Jul 20246“azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID” NCT00740792 ↗ “Azelastine HCl (Astelin) Nasal Spray, 137 mcg” NCT00979615 ↗ “azelastine Hcl 548 mcg nasal spray” NCT00660517 ↗ “Drug: azelastineHcl” NCT00883168 ↗ |
| Known as | BAYR9258 | “Drug: Azelastine hydrochloride (BAYR9258)” NCT04264637 ↗ |
| Known as | Carelastin | “Carelastin® (1 mg/ml) azelastine nasal spray” NCT05709977 ↗ |
| Known as | Children's astepro allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | E-0659 | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | NSC-758971 | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Optilast | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Optivar | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Rhinolast | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | Rhinolast allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Known as | W-2979M | ChEMBL registry synonym — accepted as the source's own label CHEMBL639 ↗ |
| Action | Inhibit | “Azelastine pretreatment inhibited the increase in albumin but not histamine levels.” PMID 18426137 ↗ Mar 20081“Histamine H1 receptor antagonist” CHEMBL639 ↗ |
| Modality | Small molecule | — CHEMBL639 ↗ |
| Route | Intranasal | “Azelastine nasal spray” NCT00117832 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL639 ↗ |