Clinical trial • Phase II/III • Immunology

Frexalimab for Kidney transplant rejection

Phase II/III trial of Frexalimab for Kidney transplant rejection.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Kidney transplant rejection
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
20-10-2025
First CTIS Authorization Date
23-02-2026

Trial design

Randomised, open-label, prograf / prograft (tacrolimus) oral capsules (0.5 mg, 1 mg, 5 mg) — comparator (dosing/schedule not specified in registry).-controlled Phase II/III trial in Sweden, Belgium, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Prograf / Prograft (tacrolimus) oral capsules (0.5 mg, 1 mg, 5 mg) — comparator (dosing/schedule not specified in registry).
Target Sample Size
343
Trial Duration For Participant
1825

Eligibility

Recruits 343 adults.

Inclusion criteria

  • {"criterion_text":"- Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.\n- Participants with low to moderate immunological risk."}

Exclusion criteria

  • {"criterion_text":"- Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.\n- Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.\n- Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.\n- Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy\n- Evidence of active or latent TB, HIV, HBV or HCV infection.\n- Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.\n- Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation","definition_or_measurement_approach":"Composite includes BPAR (biopsy-confirmed acute rejection), graft loss, and death assessed up to 1 year post kidney transplantation."}

Secondary endpoints

  • {"endpoint_text":"- eGFR at 1 year post kidney transplantation","definition_or_measurement_approach":"Estimated glomerular filtration rate (eGFR) measured at 1 year post transplant."}
  • {"endpoint_text":"- eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation","definition_or_measurement_approach":"eGFR measured at the specified timepoints post transplant."}
  • {"endpoint_text":"- Change of eGFR from Month 3 over time up to 5 years post kidney transplantation","definition_or_measurement_approach":"Change in eGFR from Month 3 through follow-up visits up to 5 years."}
  • {"endpoint_text":"- Participant status of eGFR >60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation","definition_or_measurement_approach":"Proportion of participants with eGFR >60 mL/min/1.73 m2 at specified timepoints."}
  • {"endpoint_text":"- Participant status of eGFR <60 mL/min/1.73 m² at Month 12 or with a >10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12","definition_or_measurement_approach":"Binary status evaluated at Month 12 or based on change from Month 3 to 12."}
  • {"endpoint_text":"- Proteinuria at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation","definition_or_measurement_approach":"Proteinuria measured at specified timepoints."}
  • {"endpoint_text":"- iBox score at 1 year post kidney transplantation","definition_or_measurement_approach":"iBox prognostic score assessed at 1 year."}
  • {"endpoint_text":"- Composite of participant and graft survival at 5 years post kidney transplantation","definition_or_measurement_approach":"Composite outcome of participant and graft survival assessed at 5 years."}
  • {"endpoint_text":"- Composite of participant and graft survival over time and at 6 months, 1 year, 2 years, 3 years, and 4 years post kidney transplantation","definition_or_measurement_approach":"Composite survival measures assessed over time and at specified timepoints."}
  • {"endpoint_text":"- Death-censored graft survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of graft loss)","definition_or_measurement_approach":"Death-censored graft survival assessed over time and at specified timepoints; causes of graft loss recorded."}
  • {"endpoint_text":"- Participant survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of death)","definition_or_measurement_approach":"Participant survival assessed over time and at specified timepoints; causes of death recorded."}
  • {"endpoint_text":"- Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation","definition_or_measurement_approach":"Annual and cumulative incidence of biopsy-proven acute rejection (BPAR) up to 5 years."}
  • {"endpoint_text":"- Time to first BPAR","definition_or_measurement_approach":"Time from transplant to first occurrence of BPAR."}
  • {"endpoint_text":"- Incidence of graft rejection at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation","definition_or_measurement_approach":"Incidence of graft rejection at specified timepoints."}
  • {"endpoint_text":"- Incidence of rejection episodes with clinical resolution up to 5 years post kidney transplantation","definition_or_measurement_approach":"Incidence of rejection episodes that resolve clinically, up to 5 years."}
  • {"endpoint_text":"- Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation","definition_or_measurement_approach":"Composite of BPAR, graft loss, and death assessed at 6 months."}
  • {"endpoint_text":"- Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation","definition_or_measurement_approach":"Incidence of newly formed donor-specific antibodies at 1 year."}
  • {"endpoint_text":"- Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation","definition_or_measurement_approach":"Incidence of newly formed donor-specific antibodies at 5 years."}
  • {"endpoint_text":"- Participants with AEs, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, ECG, and vital signs during the study period","definition_or_measurement_approach":"Safety outcomes including AEs, SAEs, AESIs and clinically significant abnormalities in labs, ECG and vitals during study."}
  • {"endpoint_text":"- Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period","definition_or_measurement_approach":"Device-related safety events and deficiencies collected during study."}
  • {"endpoint_text":"- Side effects of immunosuppressive therapy evaluated by MTSOSD-59R score at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study","definition_or_measurement_approach":"MTSOSD-59R score used to evaluate side effects at specified intervals."}
  • {"endpoint_text":"- Frexalimab plasma concentration over time","definition_or_measurement_approach":"Plasma pharmacokinetic measurements of frexalimab over time."}
  • {"endpoint_text":"- Incidence, titer, and persistence of ADA","definition_or_measurement_approach":"Incidence, titers and persistence of anti-drug antibodies (ADA) measured during study."}
  • {"endpoint_text":"- Incidence of new-onset diabetes post kidney transplantation","definition_or_measurement_approach":"Incidence of new-onset diabetes after transplant measured over follow-up."}
  • {"endpoint_text":"- Incidence and prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure","definition_or_measurement_approach":"Incidence/prevalence of hypertension, treatment regimens and BP measures recorded."}
  • {"endpoint_text":"- Incidence and prevalence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol","definition_or_measurement_approach":"Incidence/prevalence of dyslipidemia and lipid measures including triglycerides and cholesterol fractions."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
343
Recruitment Window Months
89
Consent Approach
Informed consent obtained using subject information and informed consent forms (L1 redacted SIS ICF main and related ICFs). Consent materials and related partner/pregnancy and caregiver information forms are available in multiple languages (examples in the registry: en, fr, nl, de, hu, it, sv, es, cs, fi). Participants provide consent; partner/pregnancy and caregiver-specific information/consent documents are included in the document set.

Methods

  • Site-based recruitment at participating transplant centres (materials and arrangements documented per-country via K1 recruitment arrangements).
  • Participant letters (K2 recruitment-material-participant-letter) provided in multiple languages.
  • Printed materials: flyers, posters, trifold leaflets (K2 recruitment-material-flyer / poster / trifold).
  • IC flipchart materials for site staff (K2-recruitment-material-ic-flipchart).
  • Video storyboard materials (K2-recruitment-material-uys-video-storyboard) used as part of recruitment materials.

Geography

Total Number Of Sites
46
Total Number Of Participants
269

Sweden

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
174
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset Huddinge
Contact Person Name
Lars Wennberg
Site Name
Uppsala University Hospital
Department Name
Akademiska Sjukhuset Department of Transplant Surgery
Contact Person Name
Tomas Lorant
Contact Person Email
tomas.lorant@surgsci.uu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska Universitetssjukhuset Transplant Centre, KPE
Contact Person Name
Jana Ekberg
Contact Person Email
jana.ekberg@vgregion.se

Belgium

Earliest CTIS Part Ii Submission Date
26-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
93
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
UZ Leuven
Department Name
UZ Leuven Campus Gasthuisberg - Nefrology
Contact Person Name
Dirk Kuypers
Contact Person Email
dirk.kuypers@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Cliniques Universitaires Saint-Luc - Nefrology
Contact Person Name
Arnaud Devresse

Germany

Earliest CTIS Part Ii Submission Date
28-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
91
Number Of Sites
3
Number Of Participants
38

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Universitätsklinikum Mainz, I. Medizinische Klinik und Poliklinik
Contact Person Name
Julia Weinmann-Menke
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charité-Campus Virchow-Klinikum Nephrologie/Intensivmedizin
Contact Person Name
Fabian Halleck
Contact Person Email
fabian.halleck@charite.de
Site Name
Universitaet Muenster
Department Name
Universitätsklinikum Münster, Innere Med. Med.Klinik D, Nephrology
Contact Person Name
Stefan Reuter
Contact Person Email
stefan.reuter@ukmuenster.de

Netherlands

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
77
Number Of Sites
2
Number Of Participants
34

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Leiden University Medical Center
Contact Person Name
Aiko De Vries
Contact Person Email
a.p.j.de_vries@lumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Universitair Medisch Centrum Groningen
Contact Person Name
Stefan Berger
Contact Person Email
s.p.berger@umcg.nl

Czechia

Earliest CTIS Part Ii Submission Date
20-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
99
Number Of Sites
2
Number Of Participants
17

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Fakultni nemocnice Ostrava Interni klinika, nefrologicka ambulance
Contact Person Name
Zdenek Lys
Contact Person Email
zdenek.lys@fno.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Institut klinicke a experimentalni mediciny Klinika nefrologie
Contact Person Name
Ondrej Viklicky
Contact Person Email
ondrej.viklicky@ikem.cz

Hungary

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
134
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Semmelweis University
Department Name
Semmelweis Egyetem Sebeszeti, Transzplantacios és Gasztroenterologiai Klinika
Contact Person Name
László Wágner
Contact Person Email
wagner.laszlo@semmelweis.hu
Site Name
University Of Debrecen
Department Name
Debreceni Egyetem Klinikai Központ Sebészeti Klinika
Contact Person Name
Balázs Áron Nemes
Contact Person Email
bnemes@hotmail.com
Site Name
University Of Pecs
Department Name
University Of Pecs-Pecsi Tudomanyegyetem Klinikai Kozpont,Sebészeti Klinika,Transzplantációs Osztály
Contact Person Name
Peter Szakaly
Contact Person Email
szakaly.peter@pte.hu

Austria

Earliest CTIS Part Ii Submission Date
18-02-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
70
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Medical University Of Vienna
Department Name
AKH Wien, Universitätsklinikum, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
Contact Person Name
Rainer Oberbauer

Spain

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
96
Number Of Sites
5
Number Of Participants
43

Sites

Site Name
Bellvitge University Hospital
Department Name
Nephrology and Renal Transplantation
Contact Person Name
Josep Maria Cruzado Garrit
Site Name
Hospital Universitario Regional De Malaga
Department Name
Nephrology
Contact Person Name
Veronica Lopez Jimenez
Contact Person Email
verolopezjim@yahoo.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Nephrology
Contact Person Name
Constantino Fernandez Rivera
Site Name
Hospital Clinic De Barcelona
Department Name
Nephrology
Contact Person Name
Fritz Herbert Diekmann
Contact Person Email
fdiekman@clinic.cat
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Nephrology
Contact Person Name
Oriol Bestard Matamoros
Contact Person Email
oriol.bestard@vallhebron.cat

Denmark

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
96
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Region Midtjylland
Department Name
Aarhus Universitetshospital The Renal Research Lab
Contact Person Name
Henrik Birn
Contact Person Email
hb@clin.au.dk

France

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
75
Number Of Sites
10
Number Of Participants
39

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
CHRU Lille - Hopital Claude Huriez Nephrologie
Contact Person Name
Francois Provot
Contact Person Email
Francois.provot@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
CHU Nantes - Hopital Hotel Dieu-Institut de transplantation urologie-néphrologie
Contact Person Name
Gilles Blancho
Contact Person Email
gilles.blancho@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
CHU de Toulouse - Hopital Rangueil Service de Nephrologie
Contact Person Name
Nassim Kamar
Contact Person Email
kamar.n@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
APHP - Centre Hospitalier la Pitie Salpetriere Service de Néphrologie et Transplantation rénale
Contact Person Name
Helene Francois
Contact Person Email
helene.francois@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
CHU Bordeaux - Hopital Pellegrin Service de Néphrologie-Transplantation-Dialyse-Aphérèses
Contact Person Name
Lionel Couzi
Contact Person Email
lionel.couzi@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
CHU Tours - Hopital Bretonneau Service de Nephrologie
Contact Person Name
Philippe Gatault
Contact Person Email
philippe.gatault@univ-tours.fr
Site Name
APHP-Hopital Necker Enfants Malades
Department Name
Service de Nephrologie
Contact Person Name
Olivier Aubert
Contact Person Email
olivier.aubert@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
HCL Lyon - Hopital Edouard Herriot Departement de Nephrologie et d'Immunologie Clinique
Contact Person Name
Olivier Thaunat
Contact Person Email
olivier.thaunat@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
CHU de Strasbourg - Nouvel Hôpital Civil Service Néphrologie-Transplantation rénale
Contact Person Name
Sophie Caillard Ohlmann
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
CHU Grenoble Alpes Nord – Hopital Michallon Sommeil et Respiration EFCR
Contact Person Name
Lionel Rostaing
Contact Person Email
lrostaing@chu-grenoble.fr

Italy

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
106
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
ASST Grande Ospedale Metropolitano Niguarda
Contact Person Name
Enrico Minetti
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Contact Person Name
Gaetano La-Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Azienda Ospedaliero Universitaria delle Marche
Contact Person Name
Andrea Ranghino
Site Name
Azienda Ospedaliera di Padova
Department Name
Azienda Ospedale - Università Padova
Contact Person Name
Lucrezia Furian
Contact Person Email
lucrezia.furian@unipd.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Contact Person Name
Evaldo Favi
Contact Person Email
evaldo.favi@unimi.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Contact Person Name
Vincenzo Cantaluppi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
IRCCS Ospedale San Raffaele
Contact Person Name
Rossana Caldara
Contact Person Email
caldara.rossana@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Contact Person Name
Federico Alberici
Contact Person Email
federico.alberici@unibs.it
Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.
Department Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.
Contact Person Name
Barbara Buscemi
Contact Person Email
bbuscemi@ismett.edu
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Azienda Ospedaliero Universitaria di Parma
Contact Person Name
Umberto Maggiore
Contact Person Email
umberto.maggiore@unipr.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Azienda Ospedaliero-Universitaria Careggi Nephrology Dialysis and Transplant Unit
Contact Person Name
Lino Caloger Cirami
Contact Person Email
ciramil@aou-careggi.toscana.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
A. O. U. Policlinico Tor Vergata
Contact Person Name
Giuseppe Tisone
Contact Person Email
tisone@uniroma2.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
A.O.U Città della Salute e della Scienza di Torino
Contact Person Name
Luigi Biancone
Contact Person Email
luigi.biancone@unito.it

Finland

Earliest CTIS Part Ii Submission Date
30-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
89
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
HUS-yhtymae
Department Name
HUS Helsinki University Hospital
Contact Person Name
Fernanda Ortiz
Contact Person Email
Fernanda.Ortiz@hus.fi

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Evidera Limited
Responsibilities
Participants' interviews
Name
Endpoint Clinical Inc.
Name
Empatica Inc.
Name
Bioclinica Inc.
Name
Accellacare Limited
Responsibilities
Home nursing (decentralized trial solution)
Name
PetMobile Kft.
Name
Discovery Life Sciences Biomarker Services GmbH
Responsibilities
Central reading of biopsies
Name
ESMS Global Limited
Responsibilities
Centralized 24-Hour Emergency System: eSMS
Name
PHOENIX lekarensky velkoobchod s.r.o.
Name
Labcorp Central Laboratory Services SARL

Third parties

  • {"country":"United Kingdom","full_name":"Evidera Limited","duties_or_roles":"Participants' interviews","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home nursing (decentralized trial solution)","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Central reading of biopsies","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Frexalimab
Active Substance
Frexalimab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous; Subcutaneous; Intramuscular
Route
Intravenous/Subcutaneous/Intramuscular
Authorisation Status
Investigational
Investigational Product Name
Prograf 0,5 mg Hartkapseln
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)
Investigational Product Name
Prograf 1 mg Hartkapseln
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)
Investigational Product Name
Prograf 5 mg Hartkapseln
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)
Investigational Product Name
Prograft 0,5 mg capsules, hard
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)
Investigational Product Name
Prograft 1 mg capsules, hard
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)
Investigational Product Name
Prograft 5 mg capsules, hard
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Licensed/authorized (marketed comparator)

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