Drugs / Oxymetazoline
Oxymetazoline
also known as
Oxymetazoline hydrochloride · oxymetazoline HCL · AGN-199201 · OXY · RVL-1201 · Afrazine · Afrin · Afrin (commercial name for oxymetazoline hydrochloride) · +8 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed isolated blepharochalasis 1 milestone | |||||
| Filed | Japan (PMDA) | — | isolated blepharochalasis | 2024-12-26 | “has filed an application in Japan for manufacturing and marketing approval of STN1013800 (generic name: oxymetazoline hydrochloride) for the treatment of acquired blepharoptosis.” santen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | OCUCLEAR | — | 1986-05-30 | fda.gov ↗ |
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07402330 | Apr → Oct 2026 expected | chemotherapy-induced alopecia, chemotherapy-induced toxicity | Applied Biology, Inc. | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06874244 | Aug 2024 → Jun 2025 | — | Louisiana State University Health Sciences Center in New Orleans | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT05006911 | Aug → Sep 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 1 | NCT05006898 | Jun → Jul 2020 | presbyopia | Optall Vision | Completed | No outcome recorded |
| Phase 1 | NCT03529487 | Aug 2018 → Dec 2023 | — | RDD Pharma Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT05148689 | Feb 2018 → Mar 2019 | — | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02154334 | Jun → Oct 2014 | allergic rhinitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01925729 | Oct 2013 → Mar 2019 | allergic rhinitis, otitis media | Cuneyt M. Alper | Completed | No outcome recorded |
| Phase 1 | NCT02778100 | Mar → Apr 2013 | common cold | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01579084 | Apr → Jun 2012 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT02457806 | Aug → Oct 2011 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01365650 | Dec 2007 → Feb 2008 | allergic rhinitis | Egalet Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01363089 | Jan → Mar 2007 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05715346 | Feb → Jun 2023 | ptosis | Levation Pharma, Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT02299557 | Nov 2014 → Jun 2015 | spinal cord injury | RDD Pharma Ltd | Completed | No outcome recorded |
| Phase 216 trials · 2 met primary | ||||||
| Phase 2 | NCT07582328 | Apr → May 2026 | nasal disorder | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT07168148 | Nov 2025 → Mar 2026 | chronic rhinitis | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06830109 | Oct 2024 → Dec 2026 expected | nasal disorder | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04104789 | Sep 2020 → Sep 2021 | dental caries, periodontitis | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03962634 | Aug → Sep 2019 | dental caries, periodontitis | Virginia Commonwealth University | Terminated | No outcome recorded |
| Phase 2 | NCT02780115 | May 2016 → Oct 2017 | presbyopia | Allergan | Completed | Met primary |
| Phase 2 | NCT02595528 | Apr 2016 → Oct 2017 | presbyopia | Allergan | Completed | Met primary |
| Phase 2 | NCT02197806 | Jul → Oct 2014 | presbyopia | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02062996 | Jun → Jul 2014 | nasal disorder | Richard Cartabuke | Withdrawn | No outcome recorded |
| Phase 2 | NCT01952990 | Sep → Oct 2013 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01807624 | Mar 2013 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01735201 | Dec 2012 → May 2013 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01701505 | Oct 2012 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01479517 | Jan → Apr 2012 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01304316 | Sep → Nov 2010 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01302483 | Dec 2008 → Jan 2009 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT05945615 | Jan 2024 → Jan 2026 | cranial nerve neuropathy, facial paralysis, ptosis | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03565887 | Jun 2018 → Apr 2019 | ptosis | RVL Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT03536949 | Jun 2018 → Mar 2019 | ptosis | RVL Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03352323 | Oct → Dec 2017 | rosacea | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT02132117 | Jun 2014 → Apr 2015 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02131636 | May → Nov 2014 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02095158 | Apr 2014 → Aug 2015 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01844830 | May → Jul 2013 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01745380 | Feb → May 2013 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01710787 | Oct 2012 → Feb 2013 | — | St. Renatus, LLC | Completed | Met primary |
| Phase 3 | NCT01660893 | Aug → Sep 2012 | — | St. Renatus, LLC | Terminated | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT07390578 | Dec 2026 → Aug 2027 expected | ptosis | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07593898 | Jan 2025 → Jan 2026 | allergic rhinitis | Dr. Behcet Uz Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04831047 | Jun 2021 → Apr 2022 | conjunctivitis, ptosis | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT04712799 | Jan 2021 → Jan 2024 | chronic obstructive pulmonary disease, nasal disorder | Sorlandet Hospital HF | Unknown | No outcome recorded |
| Phase 4 | NCT04153188 | Jan 2019 → Nov 2020 | rosacea | Candela Corporation | Completed | No outcome recorded |
| Phase 4 | NCT03590912 | Sep 2018 → Feb 2020 | otitis media with effusion | Lumbini Medical College | Completed | No outcome recorded |
| Phase 4 | NCT03620513 | Sep 2018 → Jan 2019 | disorder of pharynx | Lumbini Medical College | Completed | No outcome recorded |
| Phase 4 | NCT03502135 | Sep 2018 → Jun 2019 | pulpitis | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded |
| Phase 4 | NCT03368391 | Jan → Jun 2018 | dental pulp disorder, local anesthetic poisoning | Louisiana State University Health Sciences Center in New Orleans | Unknown | No outcome recorded |
| Phase 4 | NCT03380390 | Dec 2017 → Jun 2018 | rosacea | Aclaris Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00487032 | May 2008 → May 2009 | allergic rhinitis | Brian J Lipworth | Completed | No outcome recorded |
| Phase 4 | NCT00846326 | — | allergic rhinitis | Brian J Lipworth | Withdrawn | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT06480071 | Jan → Mar 2022 | — | Sahlgrenska University Hospital | Completed | No outcome recorded |
| — | NCT03506178 | Sep 2017 → May 2018 | obstructive sleep apnea syndrome | Beijing Tongren Hospital | Unknown | No outcome recorded |
| — | NCT02285634 | Nov 2014 → Dec 2016 | hypertensive disorder | Mayo Clinic | Completed | Missed primary |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT05001243 Comparator | Aug 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 2 | NCT06789549 Comparator | Jan → Mar 2024 | — | Padjadjaran University | Completed | No outcome recorded |
| Phase 2 | NCT01986582 Comparator | Oct 2013 → Feb 2014 | allergic rhinitis | Association Asthma, Bulgaria | Completed | No outcome recorded |
| Phase 2 | NCT01275105 Comparator | Jan → Mar 2011 | eye allergy | Eye Therapies, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00552110 Comparator | Jul 2007 → Feb 2008 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT05738564 Comparator | Sep 2021 → Apr 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT02601235 Comparator | Jan → Aug 2018 | nasal cavity disorder | EMS | Completed | No outcome recorded |
| Phase 4 | NCT07000877 Comparator | Jun 2025 → May 2028 expected | — | Telethon Kids Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT02630121 Comparator | Apr 2023 → Apr 2026 overdue | nasal disorder, obstructive sleep apnea syndrome | University of South Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT03228914 Comparator | Jun → Aug 2018 | nasal cavity polyp | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT02559440 Comparator | Feb 2014 → Feb 2015 | adenoid hypertrophy | Guangzhou Women and Children's Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01847131 Comparator | Apr 2013 → Dec 2014 | nasal disorder | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT00584987 Comparator | Jun 2007 → Jul 2009 | allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| — | NCT05348148 Comparator | Jun 2020 → Mar 2032 expected | vasomotor rhinitis | Camillians Saint Mary's Hospital Luodong | Recruiting | No outcome recorded |
| — | NCT02453841 Comparator | Dec 2015 → Apr 2017 | adenoid hypertrophy | Richard Cartabuke | Completed | No outcome recorded |
| — | NCT01850511 Background | May → Oct 2013 | nasal disorder | Mayo Clinic | Completed | No outcome recorded |
| — | NCT00584662 Comparator | Jan 2005 → Mar 2010 | chronic rhinitis | University of South Florida | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | RVL Pharmaceuticals, Inc. | Regulatory RVL Pharmaceuticals Announces Santen Obtains Manufacturing and Marketing Approval in Japan for UPNEEQ® Mini Ophthalmic Solution 0.1% rvlpharma.com ↗
This milestone expands access in Japan to the first approved non-invasive treatment for blepharoptosis, where treatment options have primarily been limited to surgical procedures. |
| 2025-12-22 | Santen Gmbh | Regulatory Santen Obtains Manufacturing and Marketing Approval in Japan for UPNEEQ® Mini Ophthalmic Solution 0.1%, a Treatment for Acquired Blepharoptosis santen.com ↗ |
| 2024-12-26 | Santen Gmbh | Regulatory Santen Applies for Manufacturing and Marketing Approval in Japan for STN1013800 (oxymetazoline hydrochloride), Eye Drops for Treatment of Acquired Blepharoptosis santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application in Japan for manufacturing and marketing approval of STN1013800 (generic name: oxymetazoline hydrochloride) for the treatment of acquired blepharoptosis. |
All press releases naming this drug 12 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 79 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxymetazoline | “followed by six drops of hydrochloride Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford,...” NCT05738564 ↗64“Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.” NCT05006898 ↗ “Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl.” NCT01479517 ↗ “After 20 min. rest, 1 spray with Otrivin®(Oxymetazoline 0,1 mg/ml) is administered to each nostril.” NCT04712799 ↗ “RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03536949 ↗ “RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03565887 ↗ “Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10” NCT03962634 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01701505 ↗ “Topical Oxymetazoline 0.1% - 7mL” NCT07402330 ↗ “Oxymetazoline ophthalmic gel” NCT05715346 ↗ |
| Known as | Afrazine | “Single intranasal dose of oxymetazoline hydrochloride (Afrazine®) (3 sprays of a 0.05% solution into each nostril)” NCT01363089 ↗ |
| Known as | Afrin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02601235 ↗ |
| Known as | Afrin (commercial name for oxymetazoline hydrochloride) | “Afrin (commercial name for oxymetazoline hydrochloride)” NCT06830109 ↗ |
| Known as | AGN-199201 | “Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.” NCT02132117 ↗ |
| Known as | Nasivion | “plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks” NCT03590912 ↗ |
| Known as | Otrivin | “After 20 min. rest, 1 spray with Otrivin®(Oxymetazoline 0,1 mg/ml) is administered to each nostril.” NCT04712799 ↗ |
| Known as | Otrivin adult nasal drops | “Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK)” NCT05738564 ↗ |
| Known as | OXY | “nasal decongestant Oxymetazoline (OXY, its differential effects on alpha 1 and alpha 2 adrenoreceptors” NCT00487032 ↗2“the intranasal decongestant oxymetazoline (OXY) is effective against nasal congestion” PMID 23562197 ↗ Mar 2013 “0.05% intranasal oxymetazoline hydrochloride (OXY)” NCT01847131 ↗ |
| Known as | Oxymetazoline - Iliadin nasal drop 0,05% | “Oxymetazoline - Iliadin nasal drop 0,05%” NCT06789549 ↗ |
| Known as | oxymetazoline HCL | “3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart” NCT02457806 ↗10“Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.” NCT02132117 ↗ “Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.” NCT02095158 ↗ “Daily application of Oxymetazoline HCL 1% cream for the 6-month study.” NCT04153188 ↗ “Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10” NCT04104789 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01844830 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01304316 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01710787 ↗ “tetracaine HCl and oxymetazoline HCL” NCT03368391 ↗ “Oxymetazoline HCl 0.05% nasal gel” NCT07582328 ↗ |
| Known as | Oxymetazoline hydrochloride | “a combination nasal spray (K305; 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride) compared with a tetracaine-only spray and a placebo spray would be safer and...” PMID 26892312 ↗ Feb 201611“This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent...” NCT02132117 ↗ “A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream...” PMID 34233378 ↗ Jul 2021 “Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)” NCT04831047 ↗ “a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection” PMID 23690356 ↗ May 2013 “RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03536949 ↗ “RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03565887 ↗ “Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))” NCT07000877 ↗ “0.05% intranasal oxymetazoline hydrochloride (OXY)” NCT01847131 ↗ “Oxymetazoline hydrochloride Cream, 1%” NCT05148689 ↗ “Drug: Oxymetazoline Hydrochloride” NCT01365650 ↗ |
| Known as | oxymetazoline hydrochloride (HCl) | “The study drug, oxymetazoline hydrochloride (HCl) 0.05% nasal gel, is a gel form of a well-known decongestant that is typically available as a nasal spray.” NCT07582328 ↗ |
| Known as | Oxymetazoline hydrogen chloride | “Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.” NCT02095158 ↗ |
| Known as | Rhofade | “Rhofade™ (oxymetazoline) cream, 1%” NCT05148689 ↗ |
| Known as | RVL-1201 | “RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03565887 ↗1“RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%” NCT03536949 ↗ |
| Known as | Upneeq | “Oxymetazoline 0.1% (Upneeq)” NCT07390578 ↗ |
| Action | Activate | “nasal decongestants (sympathomimetics acting on alpha receptors)” NCT00487032 ↗ |
| Modality | Other / unclassified | “the intranasal decongestant oxymetazoline (OXY)” PMID 23562197 ↗ Mar 2013 |
| Route | Intranasal | “Oxymetazoline 0.05% nasal solution” NCT00223691 ↗ |