Clinical trial • Phase III • Infectious Disease|Rare Disease
FOSMANOGEPIX for Invasive mold infection|Aspergillus infection|Fusarium infection|Lomentospora prolificans infection|Mucormycosis
Phase III trial of FOSMANOGEPIX for Invasive mold infection|Aspergillus infection|Fusarium infection|Lomentospora prolificans infection|Mucormycosis.
Overview
- Trial Therapeutic Area
- Infectious Disease|Rare Disease
- Trial Disease
- Invasive mold infection|Aspergillus infection|Fusarium infection|Lomentospora prolificans infection|Mucormycosis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 11-04-2025
- First CTIS Authorization Date
- 05-08-2025
Trial design
open-label, multiple comparator antifungal agents are listed as comparator options: amphotericin b (iv; dose unit mg/kg, max daily dose indicated as 5 mg/kg in product data), micafungin (iv), caspofungin acetate (iv), terbinafine hydrochloride (oral), voriconazole (iv; mg/kg dosing referenced), anidulafungin (iv), posaconazole (iv), rezafungin acetate (iv), isavuconazole (iv). specific per-arm schedules/doses are not fully specified in the ctis summary beyond maximum daily dose fields in product entries.-controlled Phase III trial across 39 sites in Belgium, France, Greece and others.
- Open Label
- Yes
- Comparator
- Multiple comparator antifungal agents are listed as comparator options: Amphotericin B (IV; dose unit mg/kg, max daily dose indicated as 5 mg/kg in product data), Micafungin (IV), Caspofungin acetate (IV), Terbinafine hydrochloride (oral), Voriconazole (IV; mg/kg dosing referenced), Anidulafungin (IV), Posaconazole (IV), Rezafungin acetate (IV), Isavuconazole (IV). Specific per-arm schedules/doses are not fully specified in the CTIS summary beyond maximum daily dose fields in product entries.
- Target Sample Size
- 116
- Trial Duration For Participant
- 240
Eligibility
Recruits 116 Vulnerable population selected. Informed consent arrangements include provisions for consent by a legally authorised representative (LAR) where applicable (documents include 'L1_SIS and ICF LAR_Redacted'). Subject information and informed consent forms are available in multiple languages (EN, FR, NL, DE, ES, IT, GR and country-specific versions listed in the documents). No paediatric assent/consent procedures are described (study population and objectives specify adult patients)..
- Pregnancy Exclusion
- 15. Patient who is pregnant or lactating.
- Vulnerable Population
- Vulnerable population selected. Informed consent arrangements include provisions for consent by a legally authorised representative (LAR) where applicable (documents include 'L1_SIS and ICF LAR_Redacted'). Subject information and informed consent forms are available in multiple languages (EN, FR, NL, DE, ES, IT, GR and country-specific versions listed in the documents). No paediatric assent/consent procedures are described (study population and objectives specify adult patients).
Inclusion criteria
- {"criterion_text":"- 1. Diagnosis of proven or probable IMI defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.\n- 2. Patient’s condition allows for appropriate infection source control measures."}
Exclusion criteria
- {"criterion_text":"- 1. Refractory hematologic malignancy.\n- 10. Other medical or psychiatric condition.\n- 11. Current use of any prohibited concomitant medication(s).\n- 12. Current/previous administration of an investigational drug within 30 days.\n- 13. Prior enrollment in this or any previous study of fosmanogepix.\n- 14. Moderate or severe hepatic impairment.\n- 15. Patient who is pregnant or lactating.\n- 16. Known hypersensitivity to fosmanogepix, manogepix, or any of the excipients.\n- 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.\n- 3. COVID-19 associated mucormycosis.\n- 4. Invasive fungal disease caused by more than one fungal pathogen are not permitted in Cohort A but are permitted in Cohort B.\n- 5. Patients with a Karnofsky Performance Status < 20 at Screening.\n- 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.\n- 7. Patients with known human immunodeficiency virus infection.\n- 8. Ongoing neurological disorders.\n- 9. Patients receiving hospice/comfort care only."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Day 42 all-cause mortality rate. [Time Frame: Day 42]","definition_or_measurement_approach":"All-cause mortality measured at Day 42 (proportion/rate of participants who have died from any cause by Day 42). Time Frame specified: Day 42."}
Secondary endpoints
- {"endpoint_text":"- 1. Proportion of patients with overall response of treatment success. [Time Frame: At Day 42, Day 84 and End of Study Treatment (EOST)]","definition_or_measurement_approach":"Proportion of patients assessed as overall treatment success at Day 42, Day 84 and at EOST."}
- {"endpoint_text":"- 2. Proportion of patients with clinical response of treatment success. [Time Frame: At Day 42, Day 84 and EOST]","definition_or_measurement_approach":"Proportion of patients with clinical response defined as treatment success at Day 42, Day 84 and EOST."}
- {"endpoint_text":"- 3. Proportion of patients with mycological response of eradication or presumed eradication. [Time Frame: At Day 42, Day 84 and EOST]","definition_or_measurement_approach":"Proportion achieving mycological eradication or presumed eradication at Day 42, Day 84 and EOST."}
- {"endpoint_text":"- 4. Proportion of patients with radiological response of complete response or partial response. [Time Frame: At Day 42, Day 84 and EOST]","definition_or_measurement_approach":"Proportion with radiological complete or partial response at Day 42, Day 84 and EOST."}
- {"endpoint_text":"- 5. All-cause mortality rate at Day 84. [Time Frame: Day 84]","definition_or_measurement_approach":"All-cause mortality measured at Day 84 (proportion of participants deceased by Day 84)."}
- {"endpoint_text":"- 6. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related AEs, adverse events of special interest (AESI), and AEs leading to discontinuation. [Time Frame: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)]]","definition_or_measurement_approach":"Incidence counts and rates of TEAEs, SAEs, treatment-related AEs, AESIs and AEs leading to discontinuation from screening through follow-up 6 weeks after EOST (approx. up to 8 months)."}
- {"endpoint_text":"- 7. Number of patients with clinically significant laboratory abnormalities. [Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)]","definition_or_measurement_approach":"Number of patients with clinically significant lab abnormalities recorded up to 6 weeks after EOST."}
- {"endpoint_text":"- 8. Number of patients with abnormal neurological examination findings [Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)]","definition_or_measurement_approach":"Number of patients with abnormal findings on neurological examination up to 6 weeks after EOST."}
- {"endpoint_text":"- 9. Assessment of 12-lead electrocardiogram (ECGs). [Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)]","definition_or_measurement_approach":"Evaluation of 12-lead ECGs for specified abnormalities from baseline through follow-up 6 weeks after EOST."}
- {"endpoint_text":"- 10. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration. [Time Frame: Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)]","definition_or_measurement_approach":"PK sampling schedule provided: pre-dose and at 3, 6, 9 hours after start of 3-hour IV infusion on Day 3 and at 24 hours prior to Day 4 dosing; plasma concentration-time profile for fosmanogepix and manogepix."}
- {"endpoint_text":"- 11. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration. [Time Frame: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs (± 1 day) and 192 hrs (± 2 days) after last dose.]","definition_or_measurement_approach":"PK sampling on days 7, 14, 28, 42 and post-dose samples at ~72 hrs and ~192 hrs after last dose to characterize plasma concentration-time after oral dosing."}
Recruitment
- Planned Sample Size
- 116
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent from the participant is required. For participants lacking capacity, consent via a legally authorised representative (LAR) is provided for (documents include 'L1_SIS and ICF LAR_Redacted'). Subject information and consent materials are available in multiple languages and country-specific versions (document titles indicate EN, FR, NL, DE, ES, IT, GR and BE variants). Pregnancy-related information and follow-up ICFs are included where relevant.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 94
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 150
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Internal medicine and Infectious diseases
- Principal Investigator Name
- Xave Thissen
- Principal Investigator Email
- xave.thissen@ghdc.be
- Contact Person Name
- Xave Thissen
- Contact Person Email
- xave.thissen@ghdc.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Infectious diseases and Immunity
- Principal Investigator Name
- Jeroen Van der Hilst
- Principal Investigator Email
- jeroen.vanderhilst@jessazh.be
- Contact Person Name
- Jeroen Van der Hilst
- Contact Person Email
- jeroen.vanderhilst@jessazh.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Johan Maertens
- Principal Investigator Email
- johan.maertens@uzleuven.be
- Contact Person Name
- Johan Maertens
- Contact Person Email
- johan.maertens@uzleuven.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Hematology
- Principal Investigator Name
- Alexander Schauwvlieghe
- Principal Investigator Email
- alexander.schauwvlieghe@azsintjan.be
- Contact Person Name
- Alexander Schauwvlieghe
- Contact Person Email
- alexander.schauwvlieghe@azsintjan.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Anne Sonet
- Principal Investigator Email
- anne.sonet@uclouvain.be
- Contact Person Name
- Anne Sonet
- Contact Person Email
- anne.sonet@uclouvain.be
- Site Name
- Hopital Erasme
- Department Name
- Infectious and tropical diseases
- Principal Investigator Name
- Maya Hites
- Principal Investigator Email
- maya.hites@hubruxelles.be
- Contact Person Name
- Maya Hites
- Contact Person Email
- maya.hites@hubruxelles.be
France
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 195
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Fanny Lanternier
- Principal Investigator Email
- fanny.lanternier@aphp.fr
- Contact Person Name
- Fanny Lanternier
- Contact Person Email
- fanny.lanternier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Department of Infectious and Tropical Diseases
- Principal Investigator Name
- David Boutoille
- Principal Investigator Email
- david.boutoille@chu-nantes.fr
- Contact Person Name
- David Boutoille
- Contact Person Email
- david.boutoille@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Department of Anesthesiology and Critical Care
- Principal Investigator Name
- Hervé Dupont
- Principal Investigator Email
- dupont.herve@chu-amiens.fr
- Contact Person Name
- Hervé Dupont
- Contact Person Email
- dupont.herve@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Department of Parasitology and Mycology
- Principal Investigator Name
- Jean-Pierre Gangneux
- Principal Investigator Email
- jean-pierre.gangneux@chu-rennes.fr
- Contact Person Name
- Jean-Pierre Gangneux
- Contact Person Email
- jean-pierre.gangneux@chu-rennes.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 29-04-2025
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 212
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Evangelismos S.A.
- Department Name
- Department of Hematology and Lymphoma
- Principal Investigator Name
- Ioannis Baltadakis
- Principal Investigator Email
- ibaltadakis@icloud.com
- Contact Person Name
- Ioannis Baltadakis
- Contact Person Email
- ibaltadakis@icloud.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Infectious Disease Unit of the University Department of Pathophysiology
- Principal Investigator Name
- Nikolaos Sipsas
- Principal Investigator Email
- nsipsas@med.uoa.gr
- Contact Person Name
- Nikolaos Sipsas
- Contact Person Email
- nsipsas@med.uoa.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Propedeutic Internal Medicine
- Principal Investigator Name
- Panagiotis Tsirigotis
- Principal Investigator Email
- pantsir@med.uoa.gr
- Contact Person Name
- Panagiotis Tsirigotis
- Contact Person Email
- pantsir@med.uoa.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 3rd University Pediatric Department
- Principal Investigator Name
- Elias Iosifidis
- Principal Investigator Email
- losifidish@auth.gr
- Contact Person Name
- Elias Iosifidis
- Contact Person Email
- losifidish@auth.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 157
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Operative Unit of Infectious Disease
- Principal Investigator Name
- Marco Falcone
- Principal Investigator Email
- Marco.falcone@unipi.it
- Contact Person Name
- Marco Falcone
- Contact Person Email
- Marco.falcone@unipi.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- O.U. Infectious and Tropical Disease
- Principal Investigator Name
- Matteo Bassetti
- Principal Investigator Email
- pi.dirmalattieinfettive@hsanmartino.it
- Contact Person Name
- Matteo Bassetti
- Contact Person Email
- pi.dirmalattieinfettive@hsanmartino.it
- Site Name
- Azienda Sanitaria Universitaria Giuliano Isontina
- Department Name
- Complex Structure Infectious Disease
- Principal Investigator Name
- Stefano Di Bella
- Principal Investigator Email
- stefano932@gmail.com
- Contact Person Name
- Stefano Di Bella
- Contact Person Email
- stefano932@gmail.com
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Infectious Diseases Unit
- Principal Investigator Name
- Alessandra Bandera
- Principal Investigator Email
- alessandra.bandera@unimi.it
- Contact Person Name
- Alessandra Bandera
- Contact Person Email
- alessandra.bandera@unimi.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Complex Structure of Infectious Disease Department
- Principal Investigator Name
- Cristina Mussini
- Principal Investigator Email
- cristina.mussini@unimore.it
- Contact Person Name
- Cristina Mussini
- Contact Person Email
- cristina.mussini@unimore.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Infectious Disease Department
- Principal Investigator Name
- Elena Seminari
- Principal Investigator Email
- e.seminari@smatteo.pv.it
- Contact Person Name
- Elena Seminari
- Contact Person Email
- e.seminari@smatteo.pv.it
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 187
- Number Of Sites
- 7
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Regino Jose Rodriguez Alvarez
- Principal Investigator Email
- REGINOJOSE.RODRIGUEZALVAREZ@osakidetza.eus
- Contact Person Name
- Regino Jose Rodriguez Alvarez
- Contact Person Email
- REGINOJOSE.RODRIGUEZALVAREZ@osakidetza.eus
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Intensive care Unit
- Principal Investigator Name
- Ricard Ferrer Roca
- Principal Investigator Email
- ricard.ferrer@vallhebron.cat
- Contact Person Name
- Ricard Ferrer Roca
- Contact Person Email
- ricard.ferrer@vallhebron.cat
- Site Name
- Hospital Del Mar
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Juan Pablo Horcajada Gallego
- Principal Investigator Email
- jhorcajada@psmar.cat
- Contact Person Name
- Juan Pablo Horcajada Gallego
- Contact Person Email
- jhorcajada@psmar.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Jesus Fortun Abete
- Principal Investigator Email
- fortunabete@gmail.com
- Contact Person Name
- Jesus Fortun Abete
- Contact Person Email
- fortunabete@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Joaquin López Contreras González
- Principal Investigator Email
- jlcontreras@santpau.cat
- Contact Person Name
- Joaquin López Contreras González
- Contact Person Email
- jlcontreras@santpau.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Infectious Diseases Department
- Principal Investigator Name
- Zaira Raquel Palacios Baena
- Principal Investigator Email
- zaira.palacios.baena@hotmail.com
- Contact Person Name
- Zaira Raquel Palacios Baena
- Contact Person Email
- zaira.palacios.baena@hotmail.com
- Site Name
- Hospital (additional listed site)
Austria
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 154
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Matthias Vossen
- Principal Investigator Email
- matthias.vossen@meduniwien.ac.at
- Contact Person Name
- Matthias Vossen
- Contact Person Email
- matthias.vossen@meduniwien.ac.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Internal Medicine, Division of Infectious Diseases
- Principal Investigator Name
- Robert Krause
- Principal Investigator Email
- robert.krause@medunigraz.at
- Contact Person Name
- Robert Krause
- Contact Person Email
- robert.krause@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Romuald Bellmann
- Principal Investigator Email
- romuald.bellmann@i-med.ac.at
- Contact Person Name
- Romuald Bellmann
- Contact Person Email
- romuald.bellmann@i-med.ac.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Department of Internal Medicine 4, Division of Infectious Diseases and Tropical Medicine
- Principal Investigator Name
- Helmut Salzer
- Principal Investigator Email
- Helmut.Salzer@kepleruniklinikum.at
- Contact Person Name
- Helmut Salzer
- Contact Person Email
- Helmut.Salzer@kepleruniklinikum.at
Germany
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 149
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Medical Clinic 2, Infectiology
- Principal Investigator Name
- Johanna Kessel
- Principal Investigator Email
- Johanna.Kessel@ukffm.de
- Contact Person Name
- Johanna Kessel
- Contact Person Email
- Johanna.Kessel@ukffm.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Medicine II
- Principal Investigator Name
- Maximilian Christopeit
- Principal Investigator Email
- m.christopeit@uke.de
- Contact Person Name
- Maximilian Christopeit
- Contact Person Email
- m.christopeit@uke.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Internal Medicine III
- Principal Investigator Name
- Oliver Kriege
- Principal Investigator Email
- oliver.kriege@unimedizin-mainz.de
- Contact Person Name
- Oliver Kriege
- Contact Person Email
- oliver.kriege@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Internal Medicine III – Division of Infectious Diseases (CIDC)
- Principal Investigator Name
- Beate Gruener
- Principal Investigator Email
- Beate.Gruener@uniklinik-ulm.de
- Contact Person Name
- Beate Gruener
- Contact Person Email
- Beate.Gruener@uniklinik-ulm.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Internal Medicine I
- Principal Investigator Name
- Jannik Stemler
- Principal Investigator Email
- jannik.stemler@uk-koeln.de
- Contact Person Name
- Jannik Stemler
- Contact Person Email
- jannik.stemler@uk-koeln.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 148
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Infectious diseases
- Principal Investigator Name
- Frank van de Veerdonk
- Principal Investigator Email
- frank.vandeveerdonk@radboudumc.nl
- Contact Person Name
- Frank van de Veerdonk
- Contact Person Email
- frank.vandeveerdonk@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Department of Hematology
- Principal Investigator Name
- Anke Bruns
- Principal Investigator Email
- a.h.w.bruns@umcutrecht.nl
- Contact Person Name
- Anke Bruns
- Contact Person Email
- a.h.w.bruns@umcutrecht.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Bart Rijnders
- Principal Investigator Email
- b.rijnders@erasmusmc.nl
- Contact Person Name
- Bart Rijnders
- Contact Person Email
- b.rijnders@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Basilea Pharmaceutica International AG Allschwil
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Psi CRO Greece
- Responsibilities
- sponsorDuties codes: 1,12,2
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties code: 4
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging vendor - central reader
- Name
- Medidata Solutions International Limited
- Responsibilities
- sponsorDuties codes: 3,7
- Name
- Primevigilance Limited
- Responsibilities
- Pharmacovigilance (PVG)
- Name
- Psi Cro AG
- Responsibilities
- sponsorDuties codes: 1,11,12,13,2,5,8
Third parties
- {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"sponsorDuties codes: 1,12,2","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"sponsorDuties codes: 3,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging vendor - central reader (sponsorDuties code: 15, value provided)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Unilog S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Element Materials Technology Iowa City Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Industry"}
- {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"PVG (pharmacovigilance) (sponsorDuties code: 15, value: 'PVG')","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"sponsorDuties codes: 1,11,12,13,2,5,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Fosmanogepix (SOLUTION FOR INFUSION)
- Active Substance
- FOSMANOGEPIX
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Investigational Product Name
- Fosmanogepix (TABLET)
- Active Substance
- FOSMANOGEPIX
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
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