Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
234
Countries
8
Sites
36
Invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
To evaluate the efficacy of fosmanogepix for the treatment of adult patients with Invasive mold infections (IMIs) caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds.
Key facts
- Sponsor
- Basilea Pharmaceutica International AG Allschwil
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 13 Feb 2026 → ongoing
- Decision date (initial)
- 2025-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Biomedical Advanced Research and Development Authority (BARDA), United States of America · Basilea Pharmaceutica International Ltd, Allschwil
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To evaluate the efficacy of fosmanogepix for the treatment of adult patients with Invasive mold infections (IMIs) caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds.
Secondary objectives 3
- 1. To evaluate the efficacy of fosmanogepix for the treatment of adult patients with IMIs caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds.
- 2. To evaluate the safety and tolerability of IV and oral fosmanogepix.
- 3. To evaluate the PK of fosmanogepix (prodrug) and manogepix (active moiety).
Conditions and MedDRA coding
Invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10017533 | Fungal infection | 100000004862 |
| 20.0 | PT | 10059045 | Scedosporium infection | 100000004862 |
| 20.0 | PT | 10017533 | Fungal infection | 100000004862 |
| 20.0 | PT | 10074171 | Aspergillus infection | 100000004862 |
| 20.0 | PT | 10074171 | Aspergillus infection | 100000004862 |
| 20.1 | PT | 10051919 | Fusarium infection | 100000004862 |
| 20.0 | PT | 10059045 | Scedosporium infection | 100000004862 |
| 20.1 | PT | 10051919 | Fusarium infection | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, Spanish Agency Of Medicines And Medical Devices, European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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.
- 2. Patient’s condition allows for appropriate infection source control measures.
Exclusion criteria 16
- 1. Refractory hematologic malignancy.
- 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- 3. Coronavirus disease 2019 (COVID-19) associated mucormycosis.
- 4. Invasive fungal disease caused by more than one fungal pathogen are not permitted in Cohort A but are permitted in Cohort B.
- 5. Patients with a Karnofsky Performance Status < 20 at Screening.
- 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
- 7. Patients with known human immunodeficiency virus infection.
- 8. Ongoing neurological disorders.
- 9. Patients receiving hospice/comfort care only.
- 10. Other medical or psychiatric condition.
- 11. Current use of any prohibited concomitant medication(s).
- 12. Current/previous administration of an investigational drug within 30 days.
- 13. Prior enrollment in this or any previous study of fosmanogepix.
- 14. Moderate or severe hepatic impairment.
- 15. Patient who is pregnant or lactating.
- 16. Known hypersensitivity to fosmanogepix, manogepix, or any of the excipients.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Day 42 all-cause mortality rate. [Time Frame: Day 42]
Secondary endpoints 11
- 1. Proportion of patients with overall response of treatment success. [Time Frame: At Day 42, Day 84 and End of Study Treatment (EOST)]
- 2. Proportion of patients with clinical response of treatment success. [Time Frame: At Day 42, Day 84 and EOST]
- 3. Proportion of patients with mycological response of eradication or presumed eradication. [Time Frame: At Day 42, Day 84 and EOST]
- 4. Proportion of patients with radiological response of complete response or partial response. [Time Frame: At Day 42, Day 84 and EOST]
- 5. All-cause mortality rate at Day 84. [Time Frame: Day 84]
- 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)]]
- 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)]
- 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)]
- 9. Assessment of 12-lead electrocardiogram (ECGs). [Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)]
- 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)]
- 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.]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11369975 · Product
- Active substance
- Fosmanogepix
- Substance synonyms
- (2-AMINO-3-(3-((4-(PYRIDIN-2-YLOXYMETHYL)PHENYL)METHYL)-1,2-OXAZOL-5-YL)PYRIDIN-1-IUM-1-YL)METHYL HYDROGEN PHOSPHATE, APX001, APX-001
- Other product name
- PF-07842805
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BASILEA PHARMACEUTICA INTERNATIONAL LTD., ALLSCHWIL
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD0000076464
PRD11369976 · Product
- Active substance
- Fosmanogepix
- Substance synonyms
- (2-AMINO-3-(3-((4-(PYRIDIN-2-YLOXYMETHYL)PHENYL)METHYL)-1,2-OXAZOL-5-YL)PYRIDIN-1-IUM-1-YL)METHYL HYDROGEN PHOSPHATE, APX001, APX-001
- Other product name
- PF-07842805
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 177 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BASILEA PHARMACEUTICA INTERNATIONAL LTD., ALLSCHWIL
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000076464
Comparator 9
SCP13251284 · ATC
- Active substance
- Caspofungin Acetate
- Substance synonyms
- Caspofungin diacetate
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 9.02 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX04 — CASPOFUNGIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP109554562 · ATC
- Active substance
- Posaconazole
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54.3 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AC04 — POSACONAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP116489927 · ATC
- Active substance
- Anidulafungin
- Substance synonyms
- V-ECHINOCANDIN
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 18.1 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX06 — ANIDULAFUNGIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP15540542 · ATC
- Active substance
- Micafungin
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 27 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX05 — MICAFUNGIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP108747161 · ATC
- Active substance
- Voriconazole
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 1444 mg/kg milligram(s)/kilogram
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AC03 — VORICONAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J02AX08 · Product
- Pharmaceutical form
- -
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 5.4 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX08 — REZAFUNGIN ACETATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP131365 · ATC
- Active substance
- Terbinafine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 45 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- D01BA02 — TERBINAFINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12611513 · ATC
- Active substance
- Amphotericin B
- Substance synonyms
- AMPHOTERICIN B PHOSPHOLIPID COMPLEX
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 900 mg/kg milligram(s)/kilogram
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AA01 — AMPHOTERICIN B
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP115684398 · ATC
- Active substance
- Isavuconazonium Sulfate
- Substance synonyms
- Isavuconazonium hydrogen sulfate
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 36.8 g gram(s)
- Max treatment duration
- 180 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AC05 — ISAVUCONAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Basilea Pharmaceutica International AG Allschwil
- Sponsor organisation
- Basilea Pharmaceutica International AG Allschwil
- Address
- Hegenheimermattweg 167b
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Basilea Pharmaceutica International AG Allschwil
- Contact name
- Clinical Medical Lead
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions International Limited ORG-100048319
|
London, United Kingdom | Interactive response technologies (IRT), E-data capture |
| Element Materials Technology Iowa City Inc. ORL-000007944
|
North Liberty, United States | Laboratory analysis |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 11, Code 12, Code 13, Code 2, Code 5, Code 8 |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Mayo Clinical Laboratories ORL-000009852
|
Rochester, United States | Laboratory analysis |
| Distefar Del Sur S.L. ORG-100022204
|
Bollullos De La Mitacion, Spain | Code 14 |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Unilog S.A. ORG-100019920
|
Markopoulo, Greece | Code 14 |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14 |
| Psi CRO Greece ORG-100047165
|
Athens, Greece | On site monitoring, Code 12, Code 2 |
| Nuvisan GmbH ORG-100011873
|
Neu-Ulm, Germany | Code 14 |
Locations
8 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 11 | 2 |
| Belgium | Ongoing, recruiting | 21 | 6 |
| France | Authorised, recruitment pending | 9 | 4 |
| Germany | Authorised, recruitment pending | 16 | 5 |
| Greece | Authorised, recruitment pending | 12 | 4 |
| Italy | Ongoing, recruiting | 8 | 6 |
| Netherlands | Ongoing, recruiting | 7 | 3 |
| Spain | Ongoing, recruiting | 10 | 6 |
| Rest of world
Israel, Thailand, Australia, Canada, Brazil, United States
|
— | 140 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Department of Internal Medicine 4, Division of Infectious Diseases and Tropical Medicine, Krankenhausstrasse 9, 4020, Linz
Medical University Of Vienna
Department of Internal Medicine I, Waehringer Guertel 18-20, Alsergrund, Vienna
Hopital Erasme
Infectious and tropical diseases, Lennikse Baan 808, 1070, Anderlecht
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Grand Hopital De Charleroi
Internal medicine and Infectious diseases, Rue Du Campus Des Viviers 1, 6060, Charleroi
Jessa Ziekenhuis
Infectious diseases and Immunity, Stadsomvaart 11, 3500, Hasselt
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Assistance Publique Hopitaux De Paris
Infectious Diseases, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Nantes
Department of Infectious and Tropical Diseases, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Rennes
Department of Parasitology and Mycology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire Amiens Picardie
Department of Anesthesiology and Critical Care, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Universitaetsklinikum Heidelberg AöR
Department for Infectious Diseases and Tropical Medicine Center for Infectious Diseases, Im Neuenheimer Feld 324, Neuenheim, Heidelberg
Universitaetsklinikum Ulm AöR
Internal Medicine III – Division of Infectious Diseases (CIDC), Albert-Einstein-Allee 23, Eselsberg, Ulm
University Hospital Cologne AöR
Internal Medicine I, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Frankfurt AöR
Medical Clinic 2, Infectiology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Internal Medicine III, Langenbeckstrasse 1, Oberstadt, Mainz
Evangelismos S.A.
Department of Hematology and Lymphoma, Ipsiladou 45-47, 106 76, Athens
Ippokratio General Hospital Of Thessaloniki
3rd University Pediatric Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Laiko General Hospital Of Athens
Infectious Disease Unit of the University Department of Pathophysiology, Agiou Thoma (goudi) 17, 115 27, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2 nd Department of Propedeutic Internal Medicine, Rimini 1, 124 61, Chaidari
Fondazione IRCCS Policlinico San Matteo
Infectious Disease Department, Viale Camillo Golgi 19, 27100, Pavia
Azienda Sanitaria Universitaria Giuliano Isontina
Complex Structure Infectious Disease, Via Costantino Costantinides 2, 34128, Trieste
Azienda Ospedaliero Universitaria Pisana
Operative Unit of Infectious Disease, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliero Universitaria Di Modena
Complex Structure of Infectious Disease Department, Largo Del Pozzo 71, 41124, Modena
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Infectious Diseases Unit, Via Francesco Sforza 28, 20122, Milan
IRCCS Ospedale Policlinico San Martino
O.U. Infectious and Tropical Disease, Largo Rosanna Benzi 10, 16132, Genoa
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Internal Medicine, P. O. Box 2040, 3000 CA, Rotterdam
Universitair Medisch Centrum Utrecht
Department of Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Radboud universitair medisch centrum Stichting
Infectious diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Universitari Vall D Hebron
Intensive care Unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Infectious Diseases Department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Infectious Diseases Department, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Cruces
Infectious Diseases Department, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Virgen De La Macarena
Infectious Diseases Department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Del Mar
Infectious Diseases Department, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-02-13 | 2026-02-13 | |||
| Italy | 2026-03-06 | 2026-03-06 | |||
| Netherlands | 2026-04-07 | 2026-04-07 | |||
| Spain | 2026-04-09 | 2026-04-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 69 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516216-16-00_Redacted | 5.0 |
| Protocol (for publication) | D1_Protocol GR_20245162161600_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_AT_DE | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_BE-FR | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_BE-NL | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient Diary_EN | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_ES | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_FR | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_GR | 2 |
| Protocol (for publication) | D4_Patient facing document_Patient diary_IT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_centre-specific contact list_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continuation_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LAR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Annex_Side effects | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow-Up_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BE-FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BE-NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Annex Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Annex to Main ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BfS Addendum_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Personal Data Use_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-Up_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP letter_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Reimbursement Form_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amphotericin B Deoxycholate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amphotericin B Lipid Complex | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amphotericin B Liposomal | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Anidulafungin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Caspofungin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Isavuconazole | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Micafungin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Posaconazole | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rezafungin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Terbinafine | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Voriconazole | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE-DE_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE-FR_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE-NL_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-516216-16-00_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR_2024-516216-16-00_Public | 5.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-11 | Austria | Acceptable with conditions 2025-08-04
|
2025-08-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-26 | Austria | Acceptable 2025-11-24
|
2025-11-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-24 | Austria | Acceptable 2026-05-26
|
2026-05-26 |