Drugs / Clemastine

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) TAVIST-1 — 1979-03-16 – 1996-10-31 fda.gov ↗
Approved US (FDA) TAVIST-1 — 1977-02-25 fda.gov ↗

Trials 15

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT07688746 Jul 2026 → Mar 2028 expected brain injury, periventricular leukomalacia Bridget LaMonica Ostrem, M.D., Ph.D. Not yet recruiting No outcome recorded
Phase 1 NCT02613091 Apr → Sep 2016 — University of California, San Francisco Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06065670 Sep 2026 → Oct 2028 expected multiple sclerosis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 1/2 NCT05359653 Aug 2023 → Jun 2027 expected primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis University of California, San Francisco Recruiting No outcome recorded
Phase 26 trials
Phase 2 NCT06591091 Dec 2025 → Dec 2026 expected depressive disorder University of Illinois at Chicago Recruiting No outcome recorded
Phase 2 NCT06087757 Apr 2024 → May 2026 overdue Williams syndrome Sheba Medical Center Active not recruiting No outcome recorded
Phase 2 NCT06315972 Apr 2024 → Nov 2026 expected schizophrenia LMU Klinikum Not yet recruiting No outcome recorded
Phase 2 NCT06315699 Mar 2024 → Mar 2025 Williams syndrome, developmental delay with or without intellectual impairment or behavioral abnormalities Qilu Hospital of Shandong University Completed No outcome recorded
Phase 2 NCT05131828 Mar 2022 → Mar 2025 multiple sclerosis Cambridge University Hospitals NHS Foundation Trust Completed No outcome recorded
Phase 2 NCT02521311 Feb 2017 → Aug 2028 expected optic neuritis University of California, San Francisco Recruiting No outcome recorded
Phase 34 trials
Phase 3 NCT05338450 Aug 2022 → Aug 2025 internuclear ophthalmoplegia, multiple sclerosis Amsterdam UMC, location VUmc Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT01257061 Sep 2012 → Apr 2013 atopic eczema EMS Completed No outcome recorded
Phase 3 NCT01239719 Mar → Jul 2011 allergic disease, dermatitis Azidus Brasil Unknown No outcome recorded
Phase 3 NCT01125761 Nov 2010 dermatitis Azidus Brasil Withdrawn No outcome recorded
Phase not applicable1 trial
— NCT03826004 Feb → Jul 2019 — Chinese Academy of Medical Sciences, Fuwai Hospital Completed No outcome recorded
Comparator or background therapy6 trials
Phase 1/2 NCT07304024 Comparator Mar 2025 → Jul 2028 expected auditory perceptual disorders, demyelinating disease, noise induced hearing loss, sensorineural hearing loss disorder University of Colorado, Denver Recruiting No outcome recorded
Phase 2 NCT02040298 Comparator Jan 2014 → Sep 2015 relapsing-remitting multiple sclerosis University of California, San Francisco Completed No outcome recorded
Phase 2 NCT00481676 Comparator May 2007 → Apr 2009 chronic urticaria Novartis Completed No outcome recorded
Phase 2 NCT01154361 Comparator — angioedema Technical University of Munich Completed Met primary
Phase 3 NCT01843530 Background Nov 2013 → Oct 2018 renin-angiotensin-aldosterone system-blocker-induced angioedema Technical University of Munich Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Clemastine “Clemastine or Cetirizine prior to paclitaxel infusion according to local care standards” NCT06118710 ↗
17

“Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion” NCT01257061 ↗

“Clemastine” NCT06591091 ↗

NCT05131828 ↗

NCT06065670 ↗

NCT07688746 ↗

NCT03826004 ↗

NCT02040298 ↗

NCT01125761 ↗

NCT02521311 ↗

NCT06087757 ↗

Show 7 more sources

Known as Clemastin ClinicalTrials.gov intervention name — accepted as the source's own label NCT01843530 ↗
1

NCT01154361 ↗

Known as Clemastina ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as Clemastine Fumarate ClinicalTrials.gov intervention name — accepted as the source's own label NCT05359653 ↗
1

NCT07304024 ↗

Known as Clemastine fumarate component of tavist-d ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as Clemastine hydrogen fumarate “Clemastine hydrogen fumarate 1.34 mg tablet for oral administration.” NCT05131828 ↗
Known as HS-592 ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as NSC-756685 ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as Tavegil ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as Tavist ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Known as Tavist-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1626 ↗
Action Inhibit “histamine H1 receptor antagonist clemastine” NCT03826004 ↗
1

“Histamine H1 receptor antagonist” CHEMBL1626 ↗

Modality Small molecule — CHEMBL1626 ↗
Route Topical “a thin layer is applied on the lesions” NCT01125761 ↗
Target HRH1 “Histamine H1 receptor antagonist” CHEMBL1626 ↗