Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43883   clinical trials with a EudraCT protocol, of which   7296   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-001951-18
    Sponsor's Protocol Code Number:INS1009-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-001951-18
    A.3Full title of the trial
    An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
    Estudio de extensión abierto para evaluar la seguridad, tolerabilidad y eficacia del uso a largo plazo de treprostinil palmitilo en polvo para inhalación en pacientes con hipertensión arterial pulmonar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study to Evaluate Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
    Estudio de extensión abierto para evaluar el uso a largo plazo de treprostinil palmitilo en polvo para inhalación en pacientes con hipertensión arterial pulmonar
    A.4.1Sponsor's protocol code numberINS1009-203
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInsmed Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInsmed Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInsmed Switzerland GmbH
    B.5.2Functional name of contact pointRegulatory Affairs Manager EU
    B.5.3 Address:
    B.5.3.1Street AddressGrafenauweg 10
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code INS1009
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.3Other descriptive nameTreprostinil palmitil inhalation powder - 80 microgram
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code INS1009
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.3Other descriptive nameTreprostinil palmitil inhalation powder - 160 microgram
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code INS1009
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.3Other descriptive nameTreprostinil palmitil inhalation powder - 320 microgram
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Participants with Pulmonary Arterial Hypertension
    Participantes con hipertensión arterial pulmonar
    E.1.1.1Medical condition in easily understood language
    Participants with high blood pressure in the arteries of the lungs
    Participantes con tension sanguínea alta en las arterias de los pulmones
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201, INS1009-202 and other lead-in studies of TPIP in participants with PAH.
    Evaluar la seguridad y tolerabilidad del uso a largo plazo de TPPI en participantes con HAP de los estudios INS1009-201, INS1009-202 y otros estudios de preinclusión de TPPI en participantes con HAP.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of the long-term use of TPIP on exercise capacity in participants with PAH.
    - To evaluate the effect of the long-term use of TPIP on blood biomarkers of disease severity in participants with PAH.
    - To evaluate the effect of the long-term use of TPIP on the mortality risk in participants with PAH.
    - To evaluate the effect of the long-term use of TPIP on the clinical status of participants with PAH.
    - To evaluate the effect of the long-term use of TPIP on the clinical worsening rate in participants with PAH.
    - To further evaluate the PK profile of the long-term use of TPIP in participants with PAH.
    - Evaluar el efecto del uso a largo plazo de TPPI sobre la capacidad de realizar ejercicio en participantes con HAP.
    - Evaluar los efectos del uso a largo plazo de TPPI sobre los biomarcadores sanguíneos de la gravedad de la enfermedad en participantes con HAP.
    - Evaluar el efecto del uso a largo plazo de TPPI sobre el riesgo de mortalidad en participantes con HAP.
    - Evaluar el efecto del uso a largo plazo de TPPI sobre el estado clínico de los participantes con HAP.
    - Evaluar el efecto del uso a largo plazo de TPPI sobre la tasa de empeoramiento clínico en participantes con HAP.
    - Evaluar más a fondo el perfil FC del uso a largo plazo de TPPI en participantes con HAP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who completed the end of treatment visit in Study INS1009-201, Study INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
    2. Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, Study INS1009-202, or any other lead-in PAH TPIP in study.
    3. Capable of giving signed informed consent.
    1. Participantes que completaron la visita de fin de tratamiento en el estudio INS1009-201, INS1009-202 o cualquier otro estudio de preinclusión de TPPI para la HAP. Los participantes para los que el estudio AAE no estaba disponible en el momento de completar el estudio de preinclusión son elegibles para inscribirse al cabo de un año de su visita de fin de tratamiento del estudio de preinclusión.
    2. Evaluaciones de selección iniciales completas que confirmen la elegibilidad para participar si han transcurrido más de 30 días desde la visita de fin de estudio en el estudio INS1009-201, estudio INS1009-202 o cualquier otro estudio de preinclusión con TPPI para la HAP.
    3. Capacidad de dar el consentimiento informado firmado.
    E.4Principal exclusion criteria
    1. Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PAH TPIP study, which, in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
    2. Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso®] or iloprost) and oral prostacyclin analogues (eg, TRE [Orenitram®]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
    3. Pregnant or breastfeeding.
    4. Any medical or psychological condition, including relevant laboratory abnormalities, at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
    1. Participantes que experimentaron cualquier hipersensibilidad o reacción adversa al medicamento o fueron retirados/discontinuados anticipadamente en un estudio previo de TPPI para la HAP, lo que, en opinión del investigador, podría indicar que continuar el tratamiento con TPPI puede presentar un riesgo irrazonable para el participante.
    2. Inicio de la administración parenteral de análogos de prostaciclina (por ejemplo, TRE, epoprostenol) desde la finalización de los estudios INS1009-201, INS1009-202 u otros estudios de TPPI. Se permite el inicio de análogos de prostaciclina inhalados (por ejemplo, TRE [Tyvaso®] o iloprost) y análogos orales de prostaciclina (por ejemplo, TRE [Orenitram®]) o agonistas del receptor (por ejemplo, selexipag) si se suspenden 24 horas antes del inicio de la administración del fármaco del estudio.
    3. Embarazo o lactancia.
    4. Cualquier afección médica o psicológica, incluidas las anomalías de laboratorio relevantes en la selección que, en opinión del investigador, sugiera una enfermedad nueva o insuficientemente entendida que pueda presentar un riesgo irrazonable para el participante del estudio como resultado de la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of TEAEs
    Frecuencia y gravedad de los AAST
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    A lo largo del estudio.
    E.5.2Secondary end point(s)
    - Change in 6MWD (absolute and relative).
    - Change in the concentration of NT-proBNP in blood.
    - Change in the REVEAL Lite 2.0 score.
    - Annualized rate of clinical worsening events (as defined in the protocol)
    - Plasma concentration levels of TP and TRE.
    - Cambio en la DR6M (absoluto y relativo).
    - Cambio en la concentración de NT-proBNP en sangre.
    - Cambio en la puntuación REVEAL Lite 2.0.
    - Tasa anualizada de acontecimientos de empeoramiento clínico (como se define en el protocolo).
    - Niveles de concentración plasmática de TP y TRE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24
    - From pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24
    - From pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24
    - Throughout the study
    - Throughout the study
    - Desde el inicio antes del OLE* hasta el mes 6, mes 12, mes 18 y mes 24
    - Desde el inicio antes del OLE* hasta el mes 6, mes 12, mes 18 y mes 24
    - Desde el inicio antes del OLE* hasta el mes 6, mes 12, mes 18 y mes 24
    - A lo largo del estudio
    - A lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Período ajuste dosis enmascarado 3 semanas para participantes incluidos del estudio de preinclusión
    3-week blinded titration period for participants enrolling immediately from a lead in study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Japan
    Malaysia
    Mexico
    Peru
    Philippines
    United States
    Austria
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Denmark
    United Kingdom
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date of the last Follow-Up phone call or visit for the last participant in the study.
    El final del estudio se define como la fecha de la última visita o llamada telefónica de seguimiento al último participante en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 99
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of the open label study, subjects will be discontinued from study medication and continue their care under their physician.
    Tras completar el estudio abierto, los pacientes dejarán de tomar la medicación y serán tratados por su médico habitual
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 21 04:40:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA