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AOP Orphan Pharmaceuticals GmbH

Home Clinical Trial Sponsors and OrganizationsAOP Orphan Pharmaceuticals GmbH

AOP Orphan Pharmaceuticals GmbH

ACTIVE

Leopold Ungar Platz 2, Wien, Austriawww.aoporphan.comPrivate51–100 employeesEstablished: 1996-01-01

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Clinical Trials

12

5 active

Approvals

11

Total approvals

Agencies

4

Regulatory bodies

Founded

1996

Overview

Trial Phase Distribution

Phase

Trials

Share

Phase 1

8

66.7%

Phase 3

2

16.7%

Phase 2

1

8.3%

Phase 4

1

8.3%

Trial Status Distribution

Active, not recruiting

5

41.7%

Recruiting

7

58.3%

Clinical Trials

Trials sponsored by this organization (12)

Multi-centre Phase 1/2 study testing LB-208 for adults with relapsed/refractory AML or high-risk MDS

May 202660 participants

Open-label, single-arm, non-controlled trial to evaluate the safety and tolerability of treprostinil sodium in children below the age of 18 years with pulmonary arterial hypertension (PAH)

Oct 202311 participants

A Phase III multicenter study to evaluate the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythaemia patients

Jun 2023129 participants

Randomized trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy in PAH group I patients – TripleTRE

Jun 2023117 participants

A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)

Active, not recruiting

Sep 202116 participants

Study the effect of Landiolol on elevated heart rate by septic shock patients

Active, not recruiting

Aug 2017200 participants

Study the effect of Landiolol on elevated heart rate by septic shock patients

Active, not recruiting

Aug 2017200 participants

Study to investigate the effectiveness and safety of AOP Landiolol in controlling supraventricular tachycardia in children.

Active, not recruiting

Jul 201760 participants

Page 1 of 2

Approvals

Approvals by Agency

FDA

Food and Drug Administration

1

Approvals

EMA

European Medicines Agency

5

Approvals

SFDA

Saudi Food and Drug Authority

2

Approvals

CIMA_AEMPS

Spanish Agency for Medicines and Medical Devices

3

Approvals

Recent Approvals

SUGAMMADEX AMOMED 100 MG/ML DE SOLUCION INYECTABLE

Sugammadex Amomed

Sugammadex Amomed

BESREMI 250 MICROGRAMOS/0,5 ML DE SOLUCION PARA INYECCION EN PLUMA PRECARGADA

News

Frankfurt Court Upholds Arbitral Award Securing BESREMi Access for Polycythemia Vera Patients

- The Frankfurt Higher Regional Court upheld an ICC arbitral award in favor of AOP Health against PharmaEssentia, confirming the Taiwanese company's liability for damages in their BESREMi dispute. - The ruling ensures continued access to BESREMi (ropeginterferon alfa-2b) for approximately 12,600 polycythemia vera patients across AOP Health's European, CIS, and Middle Eastern territories. - BESREMi represents the first interferon approved specifically for polycythemia vera treatment and is described as the most extensively studied interferon in clinical trials for this rare blood cancer indication.

On this page

Overview
Clinical Trials12
Approvals11
News1

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