Drugs / Chloroprocaine
Chloroprocaine
also known as
2-chloroprocaine · Chloroprocaine Hcl · chloroprocaine hydrochloride · CLOROTEKAL · Ampres · Chloroprocaine 3% Gel · Chloroprocaine 3% ophthalmic gel · Cloroprocaina · +3 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NESACAINE-MPF | — | 1955-03-11 | fda.gov ↗ |
Trials 24
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 missed | ||||||
| Phase 0 | NCT03414359 | Feb 2018 → Mar 2019 | — | University of Arkansas | Completed | Missed primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04779606 | Jun → Oct 2020 | — | Sintetica SA | Completed | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT03324984 | Sep 2019 → Feb 2023 | — | Montefiore Medical Center | Completed | Mixed |
| Phase 2 | NCT03993314 | Aug 2019 → Dec 2020 | pregnancy disorder | University of Alabama at Birmingham | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03918798 | Feb 2019 → Oct 2025 | flatfoot | Sintetica SA | Completed | No outcome recorded |
| Phase 2 | NCT03365752 | Jun 2018 → Feb 2021 | — | Hospital for Special Surgery, New York | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04753710 | Jun → Nov 2020 | — | Sintetica SA | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05926258 | May 2024 → Mar 2025 | — | Sintetica SA | Completed | No outcome recorded |
| Phase 3 | NCT04685538 | Sep 2020 → Mar 2021 | cataract | Sintetica SA | Completed | Met primary |
| Phase 3 | NCT02919072 | Oct 2016 → Jun 2021 | — | Sintetica SA | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02385097 | Apr 2015 → May 2017 | — | Sintetica SA | Completed | Met primary |
| Phase 412 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07348614 | Jun 2026 → Aug 2027 expected | — | Duke University | Recruiting | No outcome recorded |
| Phase 4 | NCT07456826 | Mar → Aug 2026 overdue | age-related macular degeneration, diabetic macular edema, retinal vein occlusion | Harrow Inc | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06472232 | Jun 2024 → Jun 2025 | obstetric disorder | Women's Hospital School Of Medicine Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT05934253 | Jul 2023 → Jan 2024 | — | Harrow Inc | Completed | No outcome recorded |
| Phase 4 | NCT04369950 | May 2020 → May 2021 | — | The University of Texas Health Science Center, Houston | Completed | Met primary |
| Phase 4 | NCT03967288 | Oct 2019 → Jun 2025 | — | Oregon Health and Science University | Suspended | No outcome recorded |
| Phase 4 | NCT03805438 | Feb 2019 → Oct 2020 | hypertrophic elongation of cervix | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT03305575 | Oct 2017 → Aug 2018 | cervical incompetence | Tufts Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02862912 | Nov 2016 → Jan 2020 | cervical incompetence | Columbia University | Completed | Missed primary |
| Phase 4 | NCT03805503 | Sep 2015 → Sep 2017 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01909089 | Oct 2013 → Aug 2015 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT02287870 | Jan → Apr 2008 | — | Jinling Hospital, China | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT07839039 | Nov 2026 → Dec 2028 expected | bladder exstrophy | Giorgio Veneziano | Not yet recruiting | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 0 | NCT03760718 Comparator | Sep 2019 → Sep 2020 | — | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT03428230 Background | Aug 2018 → Oct 2019 | neuropathy, painful | Sintetica SA | Completed | No outcome recorded |
| Phase 3 | NCT07674576 Background | Sep 2026 → Aug 2028 expected | — | CMC Ambroise Paré | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03260972 Comparator | Jun 2021 → Apr 2023 | — | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 4 | NCT07444827 Background | Jul 2026 → Jul 2027 expected | — | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07239999 Comparator | Mar 2026 → Apr 2027 expected | — | Nova Scotia Health Authority | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03038958 Comparator | Apr → Jul 2016 | — | Centre Hospitalier Universitaire Saint Pierre | Completed | No outcome recorded |
| Phase 4 | NCT02049255 Comparator | Nov 2013 → Oct 2014 | — | Astes | Completed | No outcome recorded |
| Phase 4 | NCT01719237 Comparator | Aug 2009 → Nov 2010 | — | University of New Mexico | Completed | No outcome recorded |
| — | NCT06376058 Comparator | Jan 2024 → Jan 2026 overdue | — | Aretaieion University Hospital | Recruiting | No outcome recorded |
| — | NCT04819503 Background | Jan → Dec 2021 | neuropathy, painful | Oslo University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02726620 Background | Jan → Dec 2017 | hypotensive disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| — | NCT00845962 Comparator | Feb → Jul 2009 | — | University of Montreal | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-08-20 | Harrow Inc | Results Harrow Announces IHEEZO® Data in Patient-Reported Discomfort Following Intravitreal Injections harrow.com ↗
The single-center, investigator-initiated study demonstrated statistically significant differences favoring IHEEZO at every measured time point. |
| 2026-07-20 | Harrow Inc | Results Harrow Highlights Growing Clinical Evidence Supporting IHEEZO® and BYOOVIZ® at ASRS 2026 Annual Meeting harrow.com ↗
One presentation highlighted interim findings from an investigator-initiated, prospective, randomized study of 150 patients comparing IHEEZO versus subconjunctival lidocaine. |
| 2026-05-26 | Apotex Inc. | Regulatory Apotex expands ophthalmic portfolio with Health Canada approval of IHEEZO™ apotex.com ↗
Apotex Inc. ("Apotex" or the "Company"), the largest Canadian-based pharmaceutical company, today announced that Health Canada has approved IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel 3%), a topical ophthalmic anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures in adults. |
| 2023-03-13 | Harrow Inc | Regulatory Harrow Announces Transitional Pass-Through Reimbursement Status for IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% harrow.com ↗
Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through reimbursement status for IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia. |
| 2023-02-02 | Harrow Inc | Regulatory Harrow Announces Permanent, Product-Specific J-Code (J2403) for IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia Effective April 1, 2023 harrow.com ↗ |
| 2023-02-01 | Sintetica SA | Regulatory Harrow Announces U.S. FDA Approval of IHEEZO™ sintetica.com ↗
IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. |
| 2022-09-27 | Harrow Inc | Regulatory Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia harrow.com ↗
today jointly announced the U.S. Food and Drug Administration (FDA) approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. |
All press releases naming this drug 10 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chloroprocaine | “Sub-study 1 is an observational study where patients with phantom and/or residual limb pain after lower limb amputation will be given spinal anaesthesia with 1% Chloroprocaine...” NCT04819503 ↗32“The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.” NCT04779606 ↗ “Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers” NCT04753710 ↗ |
| Known as | 2-chloroprocaine | “20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine” NCT01719237 ↗ |
| Known as | Ampres | ChEMBL registry synonym — accepted as the source's own label CHEMBL1179047 ↗ |
| Known as | Chloroprocaine 3% Gel | “In part I, safety and tolerability is assessed in three groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3 drops). In each group, 9...” NCT04753710 ↗ |
| Known as | Chloroprocaine 3% ophthalmic gel | “The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.” NCT04753710 ↗ |
| Known as | Chloroprocaine Hcl | “Chloroprocaine Hcl 3% Inj” NCT03805438 ↗ |
| Known as | chloroprocaine hydrochloride | “Chloroprocaine Hydrochloride 1% Sintetica is currently marketed in 9 European countries as intrathecal (spinal) anesthetic in adults where the planned surgical procedure is not...” NCT03918798 ↗1“Preservative-free chloroprocaine hydrochloride ophthalmic gel 3% administered as 3 topical drops to the study eye prior to intravitreal injection.” NCT07456826 ↗ |
| Known as | Cloroprocaina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1179047 ↗ |
| Known as | CLOROTEKAL | “compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine” NCT03993314 ↗1“chloroprocaine 40mg (Clorotekal®10 mg/mL, solution for injection, 4 mL)” NCT07674576 ↗ |
| Known as | IHEEZO | “chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia” NCT07456826 ↗ |
| Known as | Nesacaine | “45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe” NCT03805438 ↗ |
| Known as | Nesacaine-mpf | ChEMBL registry synonym — accepted as the source's own label CHEMBL1179047 ↗ |
| Modality | Other / unclassified | “two local anesthetics, bupivacaine and 2-chloroprocaine” NCT00845962 ↗ |
| Route | Other | “spinal administration of chloroprocaine 2%, 40 mg (2 mL)” NCT00845962 ↗ |