Drugs / Clonidine
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Clonidine

Other / unclassified

Developed for
delirium · hypertensive disorder · attention deficit-hyperactivity disorder · neonatal abstinence syndrome · neuropathy, painful · anxiety · radiculopathy · cardiovascular disorder
+54 more · diabetic neuropathy · intervertebral disk degenerative disorder · lumbar spinal stenosis · osteoarthritis, knee · post-traumatic stress disorder · pregnancy disorder · spondylolisthesis · autism spectrum disorder · brain hypoxia - ischemia · cancer-related condition · cannabis dependence · cardiac rhythm disease · chemotherapy-induced oral mucositis · chronic kidney disease · cirrhosis of liver · cocaine abuse · dermatitis · diabetic kidney disease · diabetic polyneuropathy · drug-induced akathisia · ganglion or cyst of synovium/tendon/bursa · heart disorder · heart failure · hyperemesis gravidarum · intracranial vasospasm · lumbar disk disease · manic bipolar affective disorder · myalgic encephalomeyelitis/chronic fatigue syndrome · opiate dependence · opioid abuse · posterior dislocation of lens · preeclampsia · pulpitis · schizophrenia · scoliosis · secondary hypertension · sickle cell disease · soft tissue neoplasm · spondylosis · subjective cognitive decline · substance dependence · substance withdrawal syndrome · substance-related disorder · Tourette syndrome · traumatic brain injury · ventricular tachycardia · benign shuddering attacks · bicipital tenosynovitis · oppositional defiant disorder · osteoarthritis · Parkinson disease · peripheral neuropathy · psychogenic movement disorders · secondary erythromelalgia
Investigated by
National Institute on Drug Abuse (NIDA) · Johns Hopkins University · Oslo University Hospital · BioDelivery Sciences International · Charite University, Berlin, Germany · Columbia University
+179 more · McMaster University · National Center for Research Resources (NCRR) · Weill Medical College of Cornell University · Centre Hospitalier Universitaire Saint Pierre · Deventer Ziekenhuis · Hamilton Health Sciences Corporation · Hospices Civils de Lyon · Makassed General Hospital · Mayo Clinic · Mclean Hospital · Medical University of Vienna · PHARMAFINA · Rigshospitalet, Denmark · University College, London · University Health Network, Toronto · University Hospital, Basel, Switzerland · University Hospital, Clermont-Ferrand · University of Iowa · University of Sao Paulo General Hospital · Vanderbilt University · Vanderbilt University Medical Center · Wake Forest University Health Sciences · Yale University · A.O.U. Città della Salute e della Scienza · ARAMU Association · ARNAS Civico Di Cristina Benfratelli Hospital · Aarhus University Hospital · Addrenex Pharmaceuticals, Inc. · American Heart Association · Ann & Robert H Lurie Children's Hospital of Chicago · Annette C. Toledano MD · Arthroplasty Foundation, Inc. · Atlantic Health System · Autism Intervention Research Network on Physical Health · Autism Treatment Network · Bambino Gesù Hospital and Research Institute · Baystate Medical Center · Birte Glenthoj · Brain & Behavior Research Foundation · Brian Williams · Brugmann University Hospital · CES University · CHU de Charleroi · Cambridge University Hospitals NHS Foundation Trust · Canadian Anesthesiologists' Society · Canadian Network and Centre for Trials Internationally · Centre Hospitalier Universitaire Dijon · Centro Neurológico de Pesquisa e Reabiitação, Brazil · Children's Hospital of Eastern Ontario · Cork University Hospital · Dr. Jean A. Ouellet, MD, FRCSC · Eastern Association for the Surgery of Trauma (EAST) · Edinburgh Napier University · Egymedicalpedia · Erasme University Hospital · Erasmus Medical Center · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Commission · Faculdade de Ciências Médicas da Santa Casa de São Paulo · Federal University of Espirito Santo · Federal University of Minas Gerais · Federal University of São Paulo · Gary L. Pierce · German Federal Ministry of Education and Research · Gianni Benzi Pharmacological Research Foundation · Glostrup University Hospital, Copenhagen · Grace Lim, MD, MS · Haukeland University Hospital · Imperial College London · Insel Gruppe AG, University Hospital Bern · Instituto Materno Infantil Prof. Fernando Figueira · Irmandade da Santa Casa de Misericordia de Sao Paulo · James Martins · Jing Liu · all 185 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) KAPVAY — 2010-09-28 – 2014-11-20 fda.gov ↗
Label expansion US (FDA) CATAPRES — 1979-09-20 fda.gov ↗
Approved US (FDA) CATAPRES — 1974-09-03 fda.gov ↗

Trials 151 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 07 trials
Phase 0 NCT04423627 Jun 2021 → Jul 2025 hypertensive disorder University of Iowa Completed No outcome recorded
Phase 0 NCT04737512 Feb 2021 → Oct 2024 attention deficit-hyperactivity disorder Yale University Completed No outcome recorded
Phase 0 NCT04263064 Mar 2020 → Aug 2022 — Medical University of South Carolina Completed No outcome recorded
Phase 0 NCT04030572 Dec 2019 → Mar 2020 cancer, neurodegenerative disease Weill Medical College of Cornell University Terminated No outcome recorded
Phase 0 NCT04032691 Aug 2019 → May 2021 — Weill Medical College of Cornell University Withdrawn No outcome recorded Stop: Business
Phase 0 NCT05037812 Mar 2019 → Mar 2028 expected — University of Utah Active not recruiting No outcome recorded
Phase 0 NCT03147092 Feb 2018 → Jun 2020 hypertensive disorder Centro Neurológico de Pesquisa e Reabiitação, Brazil Unknown No outcome recorded
Phase 112 trials
Phase 1 NCT06781632 Nov 2024 → Feb 2025 — PHARMAFINA Completed No outcome recorded
Phase 1 NCT05592379 Nov 2023 → Feb 2025 — University of Wisconsin, Madison Completed No outcome recorded
Phase 1 NCT04934228 Jul 2021 → Aug 2026 overdue diabetes mellitus, hypertensive disorder, obesity disorder University of Kansas Medical Center Recruiting No outcome recorded
Phase 1 NCT05536362 Feb 2021 → Jan 2022 colon carcinoma Egymedicalpedia Completed No outcome recorded
Phase 1 NCT03520543 May → Jul 2018 — Hospices Civils de Lyon Completed No outcome recorded
Phase 1 NCT02249039 Sep 2015 → Dec 2019 — Johns Hopkins University Completed No outcome recorded
Phase 1 NCT02548806 Sep → Dec 2015 — Valerio Therapeutics Completed No outcome recorded
Phase 1 NCT02268448 Jul 2015 → Sep 2022 dermatitis University of Minnesota Completed No outcome recorded
Phase 1 NCT01136278 Jul → Dec 2010 amphetamine abuse, mood disorder University Hospital, Basel, Switzerland Completed No outcome recorded
Phase 1 NCT00295308 Nov 2005 → Jul 2014 opiate dependence National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 1/27 trials · 1 missed
Phase 1/2 NCT06447194 Oct 2025 → Jan 2027 intervertebral disk degenerative disorder, lumbar spinal stenosis, spondylolisthesis University of Maryland, Baltimore Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT01986751 Jan 2014 → Dec 2015 — University of Alabama at Birmingham Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT01862250 Oct 2013 → Apr 2015 brain hypoxia - ischemia Johns Hopkins University Completed No outcome recorded
Phase 1/2 NCT00730054 Feb → May 2005 — Oslo University Hospital Completed No outcome recorded
Phase 1/2 NCT00194974 Jul 2004 → Mar 2005 proteinuria, toxemia of pregnancy Weill Medical College of Cornell University Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT00262470 Apr 1997 → Dec 2029 expected cardiac rhythm disease Satish R. Raj Active not recruiting Missed primary
Phase 1/2 NCT00166686 — cancer-related condition Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Withdrawn No outcome recorded
Phase 225 trials · 4 missed
Phase 2 NCT07131657 Sep → Dec 2025 — PHARMAFINA Completed No outcome recorded
Phase 2 NCT05487196 Sep 2022 → Jul 2023 pregnancy disorder Grace Lim, MD, MS Completed No outcome recorded
Phase 2 NCT05360953 Jun 2022 → Aug 2025 post-traumatic stress disorder Charite University, Berlin, Germany Suspended No outcome recorded Stop: Enrollment
Phase 2 NCT05355597 Jan 2021 → Mar 2025 musculoskeletal system disorder, soft tissue neoplasm Atlantic Health System Terminated No outcome recorded
Phase 2 NCT02812368 Aug 2016 → Jan 2017 autism spectrum disorder Ohio State University Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT02643251 Dec 2015 → Nov 2016 diabetic neuropathy, neuropathy, painful BioDelivery Sciences International Completed Missed primary
Phase 2 NCT02444559 May → Jun 2015 — Zealand University Hospital Completed No outcome recorded
Phase 2 NCT02355158 Jun 2014 → Aug 2015 diabetes mellitus, neuropathy, painful BioDelivery Sciences International Completed No outcome recorded
Phase 2 NCT01956604 Apr 2014 → Sep 2017 delirium Oslo University Hospital Terminated No outcome recorded
Phase 2 NCT02068027 Mar 2014 → Mar 2015 diabetic polyneuropathy BioDelivery Sciences International Completed Missed primary
Phase 2/35 trials · 1 missed
Phase 2/3 NCT05091242 Oct 2021 → Jan 2026 delirium Rigshospitalet, Denmark Unknown No outcome recorded
Phase 2/3 NCT04648020 Feb 2021 → May 2023 chemotherapy-induced oral mucositis Monopar Therapeutics Terminated No outcome recorded
Phase 2/3 NCT01598896 May 2012 → Aug 2017 cannabis dependence Mclean Hospital Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT02030717 Feb 2012 → May 2015 renal cell carcinoma Umeå University Completed No outcome recorded
Phase 2/3 NCT01360450 Jul 2011 neonatal abstinence syndrome Johns Hopkins University Terminated Missed primary
Phase 324 trials · 4 met primary · 4 missed
Phase 3 NCT07846657 Oct 2026 → Dec 2027 expected — MaineHealth Not yet recruiting No outcome recorded
Phase 3 NCT01876355 Jan → Dec 2024 delirium Deventer Ziekenhuis Unknown No outcome recorded
Phase 3 NCT06137924 Dec 2023 → Apr 2024 — Universidad Simón Bolívar Unknown No outcome recorded
Phase 3 NCT04877093 Jun 2023 → Mar 2027 expected post-traumatic stress disorder Wake Forest University Health Sciences Recruiting No outcome recorded
Phase 3 NCT03653832 Dec 2018 → Dec 2023 — University of Edinburgh Completed Missed primary
Phase 3 NCT03727100 Oct 2018 → Mar 2020 radiculopathy Sollis Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT03537612 Jun 2018 → Apr 2022 scoliosis Dr. Jean A. Ouellet, MD, FRCSC Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT02466373 Dec 2016 → Apr 2018 delirium Deventer Ziekenhuis Completed No outcome recorded
Phase 3 NCT02891798 Oct 2016 → Jul 2021 — Brian Williams Completed Met primary
Phase 3 NCT02740127 Jun 2016 → May 2020 male reproductive organ cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 451 trials · 2 met primary · 2 missed
Phase 4 NCT07567495 Jun 2026 → May 2028 expected — Columbia University Not yet recruiting No outcome recorded
Phase 4 NCT07313371 Jan → Jul 2026 overdue substance dependence University of Sao Paulo General Hospital Recruiting No outcome recorded
Phase 4 NCT05416840 Jan 2024 → Nov 2026 expected hypertensive disorder Jing Liu Not yet recruiting No outcome recorded
Phase 4 NCT05848531 Apr → Dec 2023 sickle cell disease Centre Hospitalier Universitaire Saint Pierre Unknown No outcome recorded
Phase 4 NCT05676814 Mar → Jun 2023 — Wake Forest University Health Sciences Completed No outcome recorded
Phase 4 NCT05824832 Feb 2023 → Jun 2026 overdue neuropathy, painful Loyola University Recruiting No outcome recorded
Phase 4 NCT05575219 Oct 2022 → Feb 2024 substance withdrawal syndrome The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 4 NCT05560230 Oct 2022 → Aug 2024 endometriosis University of Aarhus Completed No outcome recorded
Phase 4 NCT04902859 Apr 2022 → Dec 2024 retinopathy of prematurity Region Örebro County Unknown No outcome recorded
Phase 4 NCT05029726 Feb 2022 → Feb 2027 expected ganglion or cyst of synovium/tendon/bursa, intervertebral disk degenerative disorder, lumbar disk disease, lumbar spinal stenosis +3 John O'Toole Recruiting No outcome recorded
Phase not applicable20 trials · 2 met primary · 4 missed
— NCT06780865 Jan 2025 → Dec 2028 expected chronic kidney disease, secondary hypertension Shanghai Institute of Hypertension Not yet recruiting No outcome recorded
— NCT06507410 Jul → Sep 2024 overdue — Tanta University Recruiting No outcome recorded
— NCT05485480 Nov 2022 → Feb 2024 — University Hospital, Basel, Switzerland Completed No outcome recorded
— NCT05318248 Mar 2022 → Mar 2023 — Charite University, Berlin, Germany Completed No outcome recorded
— NCT02539693 Oct 2016 → Apr 2022 pilonidal sinus Makassed General Hospital Unknown No outcome recorded
— NCT02439281 May 2015 → May 2018 — Mihaela Visoiu Terminated Missed primary
— NCT02550444 Apr → May 2015 pregnancy disorder University of Sao Paulo General Hospital Completed Missed primary
— NCT02355678 Jan → Aug 2015 — Makassed General Hospital Completed Missed primary
— NCT02239627 Sep 2014 → Jun 2015 — West Virginia University Terminated No outcome recorded
— NCT02541071 Nov 2013 → Oct 2014 — Charite University, Berlin, Germany Completed No outcome recorded
Comparator or background therapy100 trials
Phase 0 NCT04833218 Comparator Jan 2020 → Jun 2021 traumatic brain injury Minia University Unknown No outcome recorded
Phase 0 NCT03388814 Background Nov 2018 → Jun 2020 breast cancer, neuropathy, painful, substance-related disorder Wake Forest University Health Sciences Withdrawn No outcome recorded Stop: Business
Phase 0 NCT02991404 Background Feb → Nov 2017 — Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT07360301 Background Oct 2026 → Feb 2028 expected — University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 1 NCT05943613 Comparator Dec 2023 → Sep 2025 — Assiut University Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2021-09-13 Monopar Therapeutics Regulatory Monopar Expands Phase 2b/3 VOICE Clinical Trial to Europe monopartx.com ↗
“Building on the numerous clinical sites we have activated in the US, we are pleased to receive authorization to proceed with the VOICE trial in France,” said Octavio Costa, MD, Chief Medical Officer of Monopar.
2017-10-26 Lupin Limited Regulatory Lupin receives FDA approval for generic Kapvay® Extended-Release Tablets lupin.com ↗
2014-02-14 Zydus Lifesciences Limited Regulatory Zydus receives final approval for Clonidine Hcl Injection zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Clonidine Hcl Injection 0.1 and 0.5 mg/ml, 10 ml.
2014-01-23 Valerio Therapeutics Regulatory FDA grants Validive® (clonidine Lauriad®) with a Fast Track Designation for the prevention and treatment of oral mucositis induced by anticancer treatments valeriotx.com ↗
FDA grants Validive® (clonidine Lauriad®) with a Fast Track Designation for the prevention and treatment of oral mucositis induced by anticancer treatments

Evidence & citations 44 cited values

Every value below carries the sentence it was read from. 254 sources stand behind the page.

FieldValueCited text
Known as Clonidine “Patients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane...” NCT03388814 ↗
244

“The "Treatment Arm" receive a single shot adductor canal block containing 20 milliliters (ml) of solution including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of...” NCT02991404 ↗

“Postoperative patient controlled epidural analgesia (epidural cathterer inserted into Th7-8 intervertebral space, 200 ml of 0.125% levobupivacaine, 4 mg of morphine, 0.075 mg...” NCT05831761 ↗

“A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the...” NCT02682498 ↗

“The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine...” NCT02026687 ↗

“In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the opioid-sparing group will receive Ketamine, Fentanyl, Lidocaine, Magnesium,...” NCT05485480 ↗

“Topical Solution of Clonidine (0.01%) + Pentoxifylline (5%) in anhydrous ethanol (6.5%), polyethylene glycol 400 (20%), propylene glycol (53.5%), and oleyl alcohol (20%)” NCT03342950 ↗

“The medication used for the block are clonidine 100 mcg, Decadron PF 5mg and 0.25% bupivacaine 5 mL. This medication will be administered once during the block.” NCT04445337 ↗

“The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride” NCT04436250 ↗

“Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.” NCT03845894 ↗

“bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline” NCT00492973 ↗

Show 234 more sources

Known as ARC-4558 “Drug: Clonidine Topical Gel (ARC-4558)” NCT00695565 ↗
Known as Catapres ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as Catapres p.l. ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as Catapres tts 1 ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as Catapres tts 2 ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as Catapres TTS-3 “Patients enrolled in the treatment group will receive an oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres...” NCT01139996 ↗
Known as Catapres, Kapvay (clonidine) “Catapres, Kapvay (clonidine)” NCT05037812 ↗
Known as Catapres-TTS “Transdermal clonidine (Catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period.” NCT00329511 ↗
Known as Catapresan “The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine...” NCT02026687 ↗
2

“Clonidine was approved by the FDA in 1974 and is registered in Austria with the brand name "Catapresan".” NCT00279253 ↗

“Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml” NCT02466373 ↗

Known as Catapress “Intervention Group: Start oral (PO/NG/OG) Clonidine HCl (Catapress) at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours depending on baby's feeding schedule.” NCT03092011 ↗
Known as Catapressan “Currently, two pharmacological α-2 agonists, clonidine (Catapressan®, Boehringer Ingelheim) and dexmedetomidine (Dexdor®, Orion Corporation), are marketed and commonly used in...” NCT04758936 ↗
Known as Catarpres-tts ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as CLON “The aim of this study was to determine the effect on family quality of life (QOL) of clonidine (CLON) and methylphenidate (MPH), used alone and in combination, in treating...” PMID 19877975 ↗ Oct 2009
2

“Alpha 2-adrenergic receptor agonists, dexmedetomidine (DEX) and clonidine (CLON) have excellent sedative-analgesics effects, do not cause respiratory depression and are...” NCT02249039 ↗

“investigational study drug, Clonidine Hydrochloride ( CLON).” NCT01862250 ↗

Known as CLON-XR “This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity...” PMID 21241954 ↗ Feb 2011
Known as CLONICEL “CLONICEL (Clonidine HCl sustained release)” NCT00723190 ↗
Known as Clonidin ClinicalTrials.gov intervention name — accepted as the source's own label NCT05318248 ↗
1

NCT00312416 ↗

Known as Clonidina ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as clonidine [Catapres, Boehringer Ingelheim, Germany] “clonidine [Catapres®, Boehringer Ingelheim, Germany]” NCT00860899 ↗
Known as Clonidine extended release ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗
Known as Clonidine Gel “Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN.” NCT02355158 ↗
1

“Clonidine Gel” NCT02643251 ↗

Known as Clonidine HCL “Interventions: Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation: Duration: (Clonidine HCL) 1 mcg/kg/dose q4 either iv or po.” NCT01360450 ↗
5

“Intervention Group: Start oral (PO/NG/OG) Clonidine HCl (Catapress) at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours depending on baby's feeding schedule.” NCT03092011 ↗

“Then, the drug test article, clonidine HCl, 0.1 mg tabs, will be administered once daily by mouth at bedtime for one week.” NCT04030572 ↗

“high dose clonidine HCl sustained release tablets for 8 weeks” NCT00556959 ↗

“Drug: Clonidine HCL” NCT00510016 ↗

“Drug: Clonidine HCL” NCT07092566 ↗

Known as Clonidine HCl sustained release “CLONICEL (Clonidine HCl sustained release)” NCT00723190 ↗
Known as Clonidine Hydrochloride “This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity...” PMID 21241954 ↗ Feb 2011
5

“investigational study drug, Clonidine Hydrochloride ( CLON).” NCT01862250 ↗

“Clonidine Hydrochloride Topical Gel, 0.1%” NCT02643251 ↗

“Drug: Clonidine Hydrochloride” NCT02953210 ↗

NCT02592915 ↗

NCT01439126 ↗

Known as Clonidine hydrochloride component of clorpres ChEMBL registry synonym — accepted as the source's own label CHEMBL134 ↗