Drugs / tetracaine
tetracaine
also known as
tetracaine HCL · Tetracaine Hydrochloride · amethocaine · Ametop · PET500 tetracaine spray
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SYNERA | — | 2005-06-23 | fda.gov ↗ |
Trials 70 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06874244 | Aug 2024 → Jun 2025 | — | Louisiana State University Health Sciences Center in New Orleans | Completed | No outcome recorded |
| Phase 0 | NCT06085352 | Jun → Dec 2023 | — | Vance Thompson Vision | Completed | No outcome recorded |
| Phase 0 | NCT02955524 | Mar 2018 → Jun 2020 | — | University of Miami | Withdrawn | No outcome recorded |
| Phase 0 | NCT02066818 | Jan 2008 → Jan 2010 | abscess | East Carolina University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02457806 | Aug → Oct 2011 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04247230 | Sep → Oct 2008 | — | Futura Medical Developments Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01654302 | Sep 2013 → Sep 2014 | osteoarthritis, knee | Thomas J. Schnitzer | Completed | No outcome recorded |
| Phase 221 trials · 2 missed | ||||||
| Phase 2 | NCT07273916 | Mar → May 2026 overdue | — | Hexsel Dermatology Clinic | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05890703 | Jun → Oct 2023 | ecthyma, ulcer of lower limbs | Juerg Hafner | Unknown | 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| Phase 2 | NCT04104789 | Sep 2020 → Sep 2021 | dental caries, periodontitis | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Enrollment |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 | NCT03233737 | Jun 2017 → Feb 2018 | — | Cetylite Industries | Completed | No outcome recorded |
| Phase 2 | NCT02908620 | Dec 2016 → Apr 2017 | — | Cetylite Industries | Completed | Missed primary |
| 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 | NCT01744197 | Jan → Feb 2013 | — | US Oncology Research | Completed | No outcome recorded |
| Phase 2 | NCT01701505 | Oct 2012 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01544283 | Mar 2012 → Jan 2014 | shoulder impingement syndrome | Injury Care Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01479517 | Jan → Apr 2012 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01202487 | Apr 2011 → Jan 2012 | — | Children's Hospital of Eastern Ontario | Completed | No outcome recorded |
| Phase 2 | NCT01304316 | Sep → Nov 2010 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01106989 | Jun → Dec 2010 | myofascial pain syndrome | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01111773 | Jun 2010 → Mar 2011 | disease of the tendon | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01115062 | Apr 2010 → Jun 2011 | — | Carol Morreale | Completed | No outcome recorded |
| Phase 2 | NCT01055444 | Mar → Aug 2010 | shoulder impingement syndrome | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01302483 | Dec 2008 → Jan 2009 | — | St. Renatus, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00609323 | Jan → Jul 2008 | postherpetic neuralgia | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00267111 | Jul 2003 → Dec 2004 | — | Mount Sinai Hospital, Canada | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02771392 | Jun 2016 → Jun 2018 | corneal disorder | New York Presbyterian Brooklyn Methodist Hospital | Unknown | No outcome recorded |
| Phase 314 trials · 3 met primary | ||||||
| Phase 3 | NCT05793892 | Apr → Aug 2023 | — | Cutia Therapeutics (Wuxi) Co., Ltd | Completed | Met primary |
| Phase 3 | NCT02483897 | Jun → Aug 2015 | corneal disorder | Queen's University | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 3 | NCT00110747 | Jun → Sep 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00110773 | Jun → Oct 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00125255 | Jun → Oct 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00110760 | Jun → Sep 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00107835 | May → Sep 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00107822 | Apr → May 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00213200 | Jul 2003 → Jun 2005 | — | The Hospital for Sick Children | Completed | Met primary |
| Phase 3 | NCT00110734 | ? → Sep 2005 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase 414 trials · 1 missed | ||||||
| Phase 4 | NCT06569537 | Oct 2024 → Dec 2025 | — | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT07688031 | May 2023 → Oct 2025 | hemorrhoid | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 4 | NCT07480135 | Apr → May 2021 | — | Vrije Universiteit Brussel | 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 | NCT04203225 | May 2017 → Nov 2019 | — | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | Missed primary |
| Phase 4 | NCT03279757 | Oct → Dec 2016 | — | Netherlands Institute for Pigment Disorders | Completed | No outcome recorded |
| Phase 4 | NCT02372786 | Nov 2014 → Sep 2015 | acne keloid | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01545765 | May 2012 | — | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01494311 | Mar → Jun 2011 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00846690 | Jan → Mar 2009 | — | The University of Texas Health Science Center, Houston | Unknown | No outcome recorded |
| Phase 4 | NCT00747669 | Sep 2008 → Apr 2013 | — | ZARS Pharma Inc. | Suspended | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00484393 | Nov 2007 → Apr 2008 | — | Fraser Health | Completed | No outcome recorded |
| Phase 4 | NCT00891163 | Dec 2006 → Apr 2007 | — | ZARS Pharma Inc. | Completed | No outcome recorded |
| Phase not applicable13 trials · 3 met primary · 1 missed | ||||||
| — | NCT07294755 | Apr 2026 → May 2027 expected | — | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT04507165 | Aug 2020 → Jul 2021 | — | Peking University People's Hospital | Unknown | Met primary |
| — | NCT02863679 | May → Sep 2016 | — | Wenzhou Medical University | Completed | No outcome recorded |
| — | NCT04378283 | May 2016 → Feb 2020 | — | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| — | NCT02502487 | Jun 2015 → Mar 2016 | — | West China Hospital | Completed | Met primary |
| — | NCT04187417 | Jan 2015 → Sep 2017 | corneal disorder | INTEGRIS Southwest Medical Center | Completed | Met primary |
| — | NCT02196441 | Aug → Oct 2014 | — | Cairo University | Unknown | No outcome recorded |
| — | NCT03342079 | Mar → Dec 2014 | — | Boston Children's Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT01842373 | Jul → Sep 2013 | — | Milton S. Hershey Medical Center | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00765934 | Nov 2009 → May 2010 | — | LabNoord | Completed | No outcome recorded |
| — | NCT00798018 | Oct 2008 → Feb 2009 | pharyngitis | Sichuan University | Completed | No outcome recorded |
| — | NCT00769392 | Sep 2008 → Aug 2009 | macular degeneration | Lahey Clinic | Completed | Missed primary |
| — | NCT00353002 | Jul → Dec 2006 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Withdrawn | No outcome recorded |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT04794842 Comparator | Aug 2021 → Dec 2023 | Meniere disease, sudden sensorineural hearing loss | Our Lady of the Lake Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT02427724 Comparator | Apr 2015 → May 2024 | lentigo | Northwestern University | Completed | No outcome recorded |
| Phase 1/2 | NCT07396129 Comparator | Aug → Dec 2026 expected | neuropathy, painful | Pontificia Universidad Catolica de Chile | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03844178 Comparator | Feb → Jun 2019 | — | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT04523961 Comparator | Jan 2021 → Feb 2025 | local anesthetic poisoning | Mayo Clinic | Completed | No outcome recorded |
| Phase 3 | NCT04685538 Comparator | Sep 2020 → Mar 2021 | cataract | Sintetica SA | Completed | Met primary |
| Phase 3 | NCT02101359 Background | Jun 2011 → Jan 2013 | cataract | Laboratoires Thea | Completed | No outcome recorded |
| Phase 4 | NCT07640256 Background | Jul 2023 → Mar 2024 | proliferative diabetic retinopathy | Asociación para Evitar la Ceguera en México | Completed | No outcome recorded |
| Phase 4 | NCT01383200 Comparator | Jun → Oct 2011 | — | University of Miami | Terminated | No outcome recorded |
| Phase 4 | NCT01005459 Comparator | Aug 2009 → Dec 2011 | — | Wake Forest University | Terminated | No outcome recorded |
| Phase 4 | NCT00716443 Comparator | Jul → Sep 2008 | — | Galderma R&D | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00670696 Comparator | Apr → Dec 2008 | — | Jazz Pharmaceuticals | Withdrawn | No outcome recorded |
| — | NCT07691346 Comparator | Sep 2026 → Jul 2028 expected | — | General Hospital of Shenyang Military Region | Not yet recruiting | No outcome recorded |
| — | NCT07495670 Background | Nov 2024 → Jan 2025 | diabetes mellitus, diabetic retinopathy | Burapha University | Completed | No outcome recorded |
| — | NCT04924621 Comparator | Jun 2021 → May 2022 | substance withdrawal syndrome | Peking University | Unknown | No outcome recorded |
| — | NCT04102878 Comparator | Jun → Oct 2019 | eyelid disorder | University Hospital Southampton NHS Foundation Trust | Unknown | No outcome recorded |
| — | NCT02726620 Background | Jan → Dec 2017 | hypotensive disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| — | NCT03143452 Comparator | Dec 2016 → Dec 2017 | cataract 50 with or without glaucoma | Indonesia University | Completed | No outcome recorded |
| — | NCT02215057 Background | Aug → Oct 2014 | iris disorder | Cairo University | Completed | No outcome recorded |
| — | NCT01914250 Comparator | Jan 2013 → Dec 2014 | — | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT01224847 Comparator | Oct → Nov 2009 | wet macular degeneration | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| — | NCT00827073 Comparator | Nov 2008 → Jul 2010 | cataract | Hermann Eye Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-06 | Cutia Therapeutics（Wuxi）Co.,Ltd | Regulatory VOLUNTARY ANNOUNCEMENT - CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) OBTAINED DRUG MARKETING AUTHORIZATION BY THE NMPA cutiatx.com ↗
CU-30101 (localized topical lidocaine and tetracaine cream) of the Group has obtained drug marketing authorization by the National Medical Products Administration (the “NMPA”) of the People ’s Republic of China ( “China”). |
| 2024-11-28 | Cutia Therapeutics（Wuxi）Co.,Ltd | Results VOLUNTARY ANNOUNCEMENT -
RESULTS OF PHASE III CLINICAL TRIAL OF
CU-40102 (TOPICAL FINASTERIDE SPRAY) AND CU-30101
(LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM)
IN CHINA WERE PRESENTED AT THE 19TH CDA ANNUAL MEETING cutiatx.com ↗
RESULTS OF PHASE III CLINICAL TRIAL OF CU-40102 (TOPICAL FINASTERIDE SPRAY) AND CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) IN CHINA WERE PRESENTED AT THE 19TH CDA ANNUAL MEETING |
| 2024-07-30 | Cutia Therapeutics（Wuxi）Co.,Ltd | Regulatory VOLUNTARY ANNOUNCEMENT - DRUG MARKETING AUTHORIZATION APPLICATION FOR CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION cutiatx.com ↗
The board of directors (the “Board”) of the Company is pleased to announce that drug marketing authorization application for CU-30101 of the Group was accepted by the National Medical Products Administration (the “NMPA”) of the PRC. |
| 2024-01-30 | Cutia Therapeutics（Wuxi）Co.,Ltd | Results VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL TRIAL OF CU-30101
(LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM)
IN CHINA REACHED PRIMARY ENDPOINT cutiatx.com ↗
The board of directors (the “Board”) of the Company is pleased to announce that the Phase III clinical trial of the Group ’s CU-30101, a localized lidocaine and tetracaine compound topical anesthesia cream for surface dermatologic operations, conducted in China reached primary endpoint. |
All press releases naming this drug 6 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tetracaine | “a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).” NCT00846690 ↗86“The safety and efficacy of the methafilcon A and tetracaine HCL components of the TetraLens BCL have safety and efficacy profiles that are well established.” NCT06085352 ↗ “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 ↗ “CTY-5339A is an investigational topical anesthetic spray containing 14% benzocaine/2% tetracaine in a metered canister.” PMID 30660443 ↗ Jan 2019 “the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone.” NCT02908620 ↗ “After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region.” NCT03279757 ↗ “Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site” NCT01115062 ↗ “BLT is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine.” NCT01842373 ↗ “Amethocaine (tetracaine 4%) (Ametop) is another topical anaesthetic cream” NCT00353002 ↗ “70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours” NCT01654302 ↗ “Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied” NCT04102878 ↗ |
| Known as | amethocaine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00213200 ↗ |
| Known as | Ametop | “Amethocaine (tetracaine 4%) (Ametop) is another topical anaesthetic cream” NCT00353002 ↗ |
| Known as | PET500 tetracaine spray | “PET500 tetracaine spray” NCT04247230 ↗ |
| Known as | tetracaine HCL | “The safety and efficacy of the methafilcon A and tetracaine HCL components of the TetraLens BCL have safety and efficacy profiles that are well established.” NCT06085352 ↗7“3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart” NCT02457806 ↗ “It is comprised of the local anesthetic tetracaine HCl and oxymetazoline which is the primary ingredient in the drug Afrin.” NCT03368391 ↗ “Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10” NCT04104789 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01304316 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01844830 ↗ “Tetracaine HCl 3% and Oxymetazoline HCl 0.05%” NCT01710787 ↗ |
| Known as | Tetracaine 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 20164“the intrapleural block will contain both ropivacaine hydrochloride injection and tetracaine hydrochloride injection” NCT07294755 ↗ “Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique” NCT06874244 ↗ “a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection” PMID 23690356 ↗ May 2013 |
| Action | Inhibit | “It acts by inhibiting sodium ion flux across the axon membrane” NCT00353002 ↗ |
| Modality | Other / unclassified | “topical anesthetics” NCT02483897 ↗ |
| Route | Topical | “S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)” NCT00107835 ↗ |