Drugs / Chloroprocaine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) NESACAINE-MPF 1955-03-11 fda.gov

Trials 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03414359 Feb 2018 → Mar 2019 University of Arkansas Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04779606 Jun → Oct 2020 Sintetica SA Completed No outcome recorded
Phase 24 trials
Phase 2 NCT03324984 Sep 2019 → Feb 2023 Montefiore Medical Center Completed No outcome recorded
Phase 2 NCT03993314 Aug 2019 → Dec 2020 pregnancy disorder University of Alabama at Birmingham Terminated No outcome recorded
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
Phase 3 NCT05926258 May 2024 → Mar 2025 Sintetica SA Completed No outcome recorded
Phase 3 NCT04685538 Sep 2020 → Mar 2021 cataract Sintetica SA Completed No outcome recorded
Phase 3 NCT02919072 Oct 2016 → Jun 2021 Sintetica SA Terminated No outcome recorded
Phase 3 NCT02385097 Apr 2015 → May 2017 Sintetica SA Completed No outcome recorded
Phase 412 trials
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 No outcome recorded
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 No outcome recorded
Phase 4 NCT03805503 Sep 2015 → Sep 2017 University Hospital, Ghent Completed No outcome recorded
Also used as a comparator or background therapy in 13 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03760718 Comparator Sep 2019 → Sep 2020 Oregon Health and Science University Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03428230 Background Aug 2018 → Oct 2019 neuropathy, painful Sintetica SA Completed No outcome recorded
Phase 32 trials
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 45 trials
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
Phase not applicable4 trials
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
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

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 37 sources stand behind the page.

FieldValueCited 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
31

“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

NCT03760718

NCT07348614

NCT00845962

NCT03365752

NCT02862912

NCT03805438

NCT01909089

NCT07444827

NCT02049255

NCT03993314

NCT07456826

NCT03967288

NCT03305575

NCT02385097

NCT03414359

NCT07239999

NCT05934253

NCT06472232

NCT02919072

NCT07674576

NCT03260972

NCT04685538

NCT03324984

NCT05926258

NCT02726620

NCT02287870

NCT03918798

NCT06376058

NCT03805503

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
2

NCT03038958

NCT04369950

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
1

NCT03428230

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