Clinical trial • Phase III • Cardiology

BOMEDEMSTAT for Essential thrombocythemia

Phase III trial of BOMEDEMSTAT for Essential thrombocythemia.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Essential thrombocythemia
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
16-11-2023
First CTIS Authorization Date
26-03-2024

Trial design

Randomised, open-label, best available therapy (bat) comparator options include: anagrelide hydrochloride monohydrate (oral, max daily dose 10 mg); ruxolitinib (oral, max daily dose 20 mg); peginterferon alfa-2a (subcutaneous injection, max single-day dose 6.43 µg as listed); busulfan (oral, max daily dose 4 mg). specific schedules not stated in the summary.-controlled Phase III trial across 50 sites in France, Italy, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Best Available Therapy (BAT) comparator options include: ANAGRELIDE HYDROCHLORIDE MONOHYDRATE (oral, max daily dose 10 mg); RUXOLITINIB (oral, max daily dose 20 mg); PEGINTERFERON ALFA-2A (subcutaneous injection, max single-day dose 6.43 µg as listed); BUSULFAN (oral, max daily dose 4 mg). Specific schedules not stated in the summary.
Target Sample Size
229

Eligibility

Recruits 229 Vulnerable population selected (isVulnerablePopulationSelected = true). Specific consent/assent handling details are not detailed in the provided record. Multiple country-specific subject information and informed consent forms (ICFs) and optional consent documents are listed for participating countries and languages..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Specific consent/assent handling details are not detailed in the provided record. Multiple country-specific subject information and informed consent forms (ICFs) and optional consent documents are listed for participating countries and languages.

Inclusion criteria

  • {"criterion_text":"- Has a diagnosis of essential thrombocythemia (ET) per World Health Organization (WHO) 2016 diagnostic criteria for myeloproliferative neoplasms. (confirmed by a central pathologist)."}
  • {"criterion_text":"- Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis"}
  • {"criterion_text":"- Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance."}
  • {"criterion_text":"- Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy"}
  • {"criterion_text":"- Has a platelet count > 450 × 10^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention"}
  • {"criterion_text":"- Has an absolute neutrophil count (ANC) ≥0.75 × 10^9/L assessed up to 72 hours before first dose of study intervention"}
  • {"criterion_text":"- Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea"}

Exclusion criteria

  • {"criterion_text":"- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) that contraindicates participation"}
  • {"criterion_text":"- History of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study"}
  • {"criterion_text":"- Evidence at the time of Screening of increased risk of bleeding"}
  • {"criterion_text":"- History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder"}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Durable Clinicohematologic Response (DCHR) Rate","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score","definition_or_measurement_approach":"Measured by MFSAF v4.0 individual fatigue symptom item score (change from baseline)."}
  • {"endpoint_text":"- Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score","definition_or_measurement_approach":"Measured by PROMIS Fatigue SF-7a total fatigue score (change from baseline)."}
  • {"endpoint_text":"- Change from Baseline in Total Symptom Score as Measured on the MFSAF v4.0","definition_or_measurement_approach":"Measured by MFSAF v4.0 total symptom score (change from baseline)."}
  • {"endpoint_text":"- Duration of Clinicohematologic Response (DOCHR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of Hematologic Remission (DOHR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of Participants with Thrombotic Events","definition_or_measurement_approach":"Proportion/percentage of participants experiencing thrombotic events as captured in safety/AE reporting."}
  • {"endpoint_text":"- Percentage of Participants with Major Hemorrhagic Events","definition_or_measurement_approach":"Proportion/percentage of participants experiencing major hemorrhagic events as captured in safety/AE reporting."}
  • {"endpoint_text":"- Disease Progression Rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants with An Adverse Event (AE)","definition_or_measurement_approach":"Count of participants reporting at least one adverse event (AE)."}
  • {"endpoint_text":"- Number of Participants Discontinuing from Study Therapy Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study therapy because of an adverse event (AE)."}

Recruitment

Planned Sample Size
229
Recruitment Window Months
56
Consent Approach
Informed consent is obtained using country-specific subject information and informed consent forms (multiple L1_ICF documents listed across participating countries and languages). Optional prescreening consent forms and optional/addendum documents (e.g., for prescreening, pregnancy follow-up, genetic consent) are provided per country. The record does not specify age-specific assent procedures.

Geography

Total Number Of Sites
50
Total Number Of Participants
155

France

Earliest CTIS Part Ii Submission Date
12-01-2024
Latest Decision Or Authorization Date
28-10-2025
Processing Time Days
655
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology
Principal Investigator Name
Marc Bernard
Principal Investigator Email
marc.bernard@chu-rennes.fr
Contact Person Name
Marc Bernard
Contact Person Email
marc.bernard@chu-rennes.fr
Site Name
Centre Hospitalier De Roubaix
Department Name
Hematology unit
Principal Investigator Name
Mathieu Wemeau
Principal Investigator Email
mathieu.wemeau@ch-roubaix.fr
Contact Person Name
Mathieu Wemeau
Contact Person Email
mathieu.wemeau@ch-roubaix.fr
Site Name
Hopital Saint Louis
Department Name
Pharmacologic and Clinical Investigations
Principal Investigator Name
Jean-Jacques Kiladjian
Principal Investigator Email
jean-jacques.kiladjian@aphp.fr
Contact Person Name
Jean-Jacques Kiladjian
Contact Person Email
jean-jacques.kiladjian@aphp.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Clinical hematology and cell therapy
Principal Investigator Name
Amelie Penot
Principal Investigator Email
amelie.penot@chu-limoges.fr
Contact Person Name
Amelie Penot
Contact Person Email
amelie.penot@chu-limoges.fr
Site Name
CHRU De Nancy
Department Name
Hematology and Intern Medicine
Principal Investigator Name
Dana Ranta
Principal Investigator Email
d.ranta@chru-nancy.fr
Contact Person Name
Dana Ranta
Contact Person Email
d.ranta@chru-nancy.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and cell therapy
Principal Investigator Name
Antoine Machet
Principal Investigator Email
a.machet@chu-tours.fr
Contact Person Name
Antoine Machet
Contact Person Email
a.machet@chu-tours.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Hematology
Principal Investigator Name
Fiorenza Barraco
Principal Investigator Email
fiorenza.barraco@chu-lyon.fr
Contact Person Name
Fiorenza Barraco
Contact Person Email
fiorenza.barraco@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Rennes (duplicate entry not expected)

Italy

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
787
Number Of Sites
12
Number Of Participants
33

Sites

Site Name
Careggi University Hospital
Department Name
Ematologia
Principal Investigator Name
Alessandro Maria Vannucchi
Principal Investigator Email
studiclinici-emato@sc-saluteumana.unifi.it
Contact Person Name
Alessandro Maria Vannucchi
Site Name
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Department Name
SCDU Ematologia
Principal Investigator Name
Monia Marchetti
Principal Investigator Email
monia.marchetti@ospedale.al.it
Contact Person Name
Monia Marchetti
Contact Person Email
monia.marchetti@ospedale.al.it
Site Name
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Department Name
S.C. Ematologia Trial Unit
Principal Investigator Name
Marco Brociner
Principal Investigator Email
marco.brociner@asst-settelaghi.it
Contact Person Name
Marco Brociner
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia ed Ematologia Clinica e Sperimentale
Principal Investigator Name
Alessandro Lucchesi
Principal Investigator Email
alessandro.lucchesi@irst.emr.it
Contact Person Name
Alessandro Lucchesi
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Ematologia
Principal Investigator Name
Alessia Tieghi
Principal Investigator Email
alessia.tieghi@ausl.re.it
Contact Person Name
Alessia Tieghi
Contact Person Email
alessia.tieghi@ausl.re.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
U.O. di Ematologia
Principal Investigator Name
Francesco Cavazzini
Principal Investigator Email
cvzfnc@unife.it
Contact Person Name
Francesco Cavazzini
Contact Person Email
cvzfnc@unife.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Ematologia
Principal Investigator Name
Daniele Cattaneo
Principal Investigator Email
daniele.cattaneo@policlinico.mi.it
Contact Person Name
Daniele Cattaneo
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncoematologia
Principal Investigator Name
Elisabetta Calistri
Principal Investigator Email
elisabetta.calistri@iov.veneto.it
Contact Person Name
Elisabetta Calistri
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
SCDU Ematologia
Principal Investigator Name
Daniela Cilloni
Principal Investigator Email
daniela.cilloni@unito.it
Contact Person Name
Daniela Cilloni
Contact Person Email
daniela.cilloni@unito.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Ematologica
Principal Investigator Name
Erika Morsi
Principal Investigator Email
erika.morsia@ospedaliriuniti.marche.it
Contact Person Name
Erika Morsi
Site Name
Other Italy site (entry present in record)
Site Name
Other Italy site (entry present in record)

Netherlands

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
783
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Principal Investigator Name
Peter Westerweel
Principal Investigator Email
p.e.westerweel@asz.nl
Contact Person Name
Peter Westerweel
Contact Person Email
p.e.westerweel@asz.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Internal medicine
Principal Investigator Name
Coty Bruggeman
Principal Investigator Email
coty.bruggeman@mzh.nl
Contact Person Name
Coty Bruggeman
Contact Person Email
coty.bruggeman@mzh.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Principal Investigator Name
Emanuele Ammatuna
Principal Investigator Email
e.ammatuna@umcg.nl
Contact Person Name
Emanuele Ammatuna
Contact Person Email
e.ammatuna@umcg.nl

Germany

Earliest CTIS Part Ii Submission Date
06-03-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
797
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Principal Investigator Name
Steffen Koschmieder
Principal Investigator Email
skoschmieder@ukaachen.de
Contact Person Name
Steffen Koschmieder
Contact Person Email
skoschmieder@ukaachen.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Innere Medizin IV
Principal Investigator Name
Haifa Al-Ali
Principal Investigator Email
dekanin@medizin.uni-halle.de
Contact Person Name
Haifa Al-Ali
Contact Person Email
dekanin@medizin.uni-halle.de
Site Name
Technische Universitat Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Katja Sockel
Principal Investigator Email
Katja.Sockel@ukdd.de
Contact Person Name
Katja Sockel
Contact Person Email
Katja.Sockel@ukdd.de

Sweden

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
805
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Region Oerebro Laen
Department Name
Sektionen för hematologi
Principal Investigator Name
Erik Ahlstrand
Principal Investigator Email
erik.ahlstrand@regionorebrolan.se
Contact Person Name
Erik Ahlstrand
Site Name
Karolinska University Hospital
Department Name
ME Hematologi
Principal Investigator Name
Anna Ravn Landtblom
Principal Investigator Email
anna.ravn-landtblom@regionstockholm.se
Contact Person Name
Anna Ravn Landtblom

Hungary

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
791
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Zsolt Nagy
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt Nagy
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Haematológiai osztály
Principal Investigator Name
László Szerafin
Principal Investigator Email
szerafin@josa.hu
Contact Person Name
László Szerafin
Contact Person Email
szerafin@josa.hu
Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Árpád Illés
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
II. Belgyógyászat - Haematológia
Principal Investigator Name
Zsolt Lázár
Principal Investigator Email
lazarzsolt@petz.gyor.hu
Contact Person Name
Zsolt Lázár
Contact Person Email
lazarzsolt@petz.gyor.hu

Poland

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
791
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Pratia Hematologia Sp. z o.o.
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
anna.jakubiec@pratia.com
Contact Person Name
Sebastian Grosicki
Contact Person Email
anna.jakubiec@pratia.com

Portugal

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
806
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Hematology Service
Principal Investigator Name
Celina Afonso
Principal Investigator Email
ensaiosclinicos@chlo.min-saude.pt
Contact Person Name
Celina Afonso
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Hematology and bone marrow transplantation service
Principal Investigator Name
Jose Mario Mariz
Principal Investigator Email
Clinicalstudies@ipoporto.min-saude.pt
Contact Person Name
Jose Mario Mariz
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Oncology Service
Principal Investigator Name
Claudia Moreira
Principal Investigator Email
claudia.p.moreira@hb.min-saude.pt
Contact Person Name
Claudia Moreira

Spain

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
784
Number Of Sites
13
Number Of Participants
38

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de hematología
Principal Investigator Name
Alberto Alvarez Larran
Principal Investigator Email
aalvar@clinic.cat
Contact Person Name
Alberto Alvarez Larran
Contact Person Email
aalvar@clinic.cat
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Servicio de hematología
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
uicico_badalona@iconcologia.net
Contact Person Name
Blanca Xicoy Cirici
Site Name
Hospital General Universitario De Albacete
Department Name
Servicio de hematología
Principal Investigator Name
Alberto Marín Sanchez
Principal Investigator Email
pibems@hotmail.com
Contact Person Name
Alberto Marín Sanchez
Contact Person Email
pibems@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de hematología y hemoterapia
Principal Investigator Name
Gonzalo Carreño Gómez-Tarragona
Principal Investigator Email
gonzalo.carreno@salud.madrid.org
Contact Person Name
Gonzalo Carreño Gómez-Tarragona
Site Name
Hospital Del Mar
Department Name
Hematology
Principal Investigator Name
Maria Alicia Senin Magan
Principal Investigator Email
msenin@psmar.cat
Contact Person Name
Maria Alicia Senin Magan
Contact Person Email
msenin@psmar.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de hematología
Principal Investigator Name
Manuel Mateo Pérez Encinas
Principal Investigator Email
Manuel.Mateo.Perez.Encinas@sergas.es
Contact Person Name
Manuel Mateo Pérez Encinas
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Servicio de hematología
Principal Investigator Name
Carolina Maria Martinez Gomez
Principal Investigator Email
carolinamariamartinez@iconcologia.net
Contact Person Name
Carolina Maria Martinez Gomez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de hematología
Principal Investigator Name
Maria Laura Fox
Principal Investigator Email
laura.fox@vallhebron.cat
Contact Person Name
Maria Laura Fox
Contact Person Email
laura.fox@vallhebron.cat
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de hematología
Principal Investigator Name
Regina García Delgado
Principal Investigator Email
reginagarciadel@yahoo.es
Contact Person Name
Regina García Delgado
Contact Person Email
reginagarciadel@yahoo.es
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de hematología
Principal Investigator Name
Jesus Maria Hernandez Rivas
Principal Investigator Email
jmhr@usal.es
Contact Person Name
Jesus Maria Hernandez Rivas
Contact Person Email
jmhr@usal.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Servicio de hematología
Principal Investigator Name
Maria Jose Fernandez Llavador
Principal Investigator Email
fernandez_mjolla@gva.es
Contact Person Name
Maria Jose Fernandez Llavador
Contact Person Email
fernandez_mjolla@gva.es
Site Name
Hospital Costa Del Sol
Department Name
Servicio de hematología
Principal Investigator Name
María Isabel Mata Vázquez
Principal Investigator Email
Maribelmata500@gmail.com
Contact Person Name
María Isabel Mata Vázquez
Contact Person Email
Maribelmata500@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de hematología
Principal Investigator Name
José Valentín García Gutierrez
Principal Investigator Email
jvalentin.garcia@salud.madrid.org
Contact Person Name
José Valentín García Gutierrez

Belgium

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
805
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Haematology
Principal Investigator Name
Nikki Granacher
Principal Investigator Email
nikki.granacher@zna.be
Contact Person Name
Nikki Granacher
Contact Person Email
nikki.granacher@zna.be

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Perceptive Eclinical Limited
Responsibilities
EUB Call center and medical escalation service
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
Signant Health Global Solutions Limited
Responsibilities
Electronic PRO/eCOA and related services (sponsor duties codes listed)
Name
AG Mednet Inc.
Responsibilities
Support services (sponsor duties code 13)
Name
Hematogenix Laboratory Services LLC
Responsibilities
Laboratory/testing services (sponsor duties code 4)

Third parties

  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Sponsor duties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Sponsor duties codes: 13","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"EUB Call center and medical escalation service (sponsor duties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited (additional entry)","duties_or_roles":"Sponsor duties codes: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting) (sponsor duties code 15)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-3543
Active Substance
BOMEDEMSTAT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
No marketing authorisation number (marketingAuthNumber = '-')
Maximum Dose
175 mg (max daily dose amount listed)

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