Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.

Start Date01 Jan 2025

Sponsor / Collaborator

PharmaEssentia Corp.

NCT06770842

/ Not yet recruitingPhase 2

Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy

In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.

Start Date01 Jan 2025

Sponsor / Collaborator

The University of Hong Kong

NCT06468033

/ Not yet recruitingPhase 3

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.
Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Start Date01 Dec 2024

Sponsor / Collaborator

PharmaEssentia Corp.

100 Clinical Results associated with Ropeginterferon alfa-2b-NJFT

100 Translational Medicine associated with Ropeginterferon alfa-2b-NJFT

100 Patents (Medical) associated with Ropeginterferon alfa-2b-NJFT

246

Literatures (Medical) associated with Ropeginterferon alfa-2b-NJFT

01 Mar 2025·British Journal of Haematology

The dosage of ropeginterferon in polycythaemia vera: Balancing efficacy, safety and pharmacoeconomics across risk categories

Letter

Author: Barbui, Tiziano ; Tefferi, Ayalew ; Vannucchi, Alessandro M.

01 Mar 2025·British Journal of Haematology

The higher initial dose and accelerated titration regimen of ropeginterferon as a treatment option for certain patients with polycythaemia vera

Letter

Author: Qin, Albert ; Zhang, Lei ; Jin, Jie

01 Feb 2025·Current Medical Research and Opinion

Improving the management of Polycythemia Vera patients eligible for cytoreduction: report of a multidisciplinary advisory board

Article

Author: Marietta, Marco ; Sani, Gabriele ; Peris, Ketty ; Ramundo, Francesco ; Betti, Silvia ; Pontecorvi, Alfredo ; Rossi, Elena ; De Stefano, Valerio

INTRODUCTIONThe management of patients with Polycythemia Vera (PV) traditionally includes low-dose aspirin, phlebotomy, and cytoreductive therapy for high-risk individuals. Recent evidence suggests that cytoreductive treatment may be warranted for patients with additional risk factors beyond the traditional criteria of a history of thrombosis and age over 60 years. Introducing new therapeutic agents, including ropeginterferon alfa-2b and ruxolitinib, enables a more personalized treatment approach tailored to individual patient characteristics.CASE REPORTThis report presents three complex clinical scenarios involving patients with PV who required cytoreductive therapy, which were discussed by a multidisciplinary advisory board. Each case is accompanied by a concise literature review and recommendations from non-hematologist specialists on managing adverse events associated with cytoreductive treatment. A multidisciplinary expert panel has identified three conceptual pathways to guide clinicians in selecting cytoreductive therapies and managing their associated complications.CONCLUSIONThe advent of new criteria for starting cytoreduction and the approval of novel drugs for PV has increased the complexity of selecting appropriate cytoreductive therapies. A multidisciplinary approach is increasingly essential to ensure personalized care that maximizes tolerability and minimizes adverse events, particularly given the often chronic nature of the treatment.

News (Medical) associated with Ropeginterferon alfa-2b-NJFT

17 Feb 2025

·www.aop-health.com

AOP Health: ICC Arbitral Tribunal rules in favor of AOP Health in arbitration proceedings pertaining to BESREMi® (Ropeginterferon alfa-2b)

(Vienna, 17.02.2025) Today, a tribunal under the auspices of the International Chamber of Commerce (ICC) served a partial final award in a dispute between PharmaEssentia Corp. (“PharmaEssentia”) and AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in AOP Health’s favor. At the heart of the case were reciprocal claims for damages arising from a dispute regarding a licensing agreement between the parties. The product in dispute The conflict centers around ropeginterferon alfa-2b, a substance launched in 2019 and that AOP Health has developed into an innovative treatment (BESREMi®) for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines1. AOP Health had acquired the rights for both BESREMi®’s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its sixth year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 9,000 patients in AOP Health’s licensed territory. First arbitration and set-aside proceedings Since 2017, PharmaEssentia repeatedly sought to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal ruled these attempts unjustified. AOP Health was awarded approx. EUR 143 million in damages for project delays caused by PharmaEssentia, while the latter´s counterclaims were dismissed. PharmaEssentia’s 2021 application to set aside the award was rejected by the Frankfurt Higher Regional Court. Upon its subsequent appeal to the German Federal Supreme Court, the agreement’s validity and the dismissal of PharmaEssentia 's counterclaims was upheld. The German Federal Supreme Court found procedural flaws with respect to damage quantification of the awarded approx. EUR 143 million, impacting the damages awarded. Second arbitration In November 2020, PharmaEssentia initiated a legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia, and the misuse of AOP Health’s clinical trial data for PharmaEssentia’s US marketing authorization. Result: partial final award in favor of AOP Health While the partial final award rules in favor of AOP Health regarding PEC's intentional breaches and liability for several claims, the tribunal’s decision on the quantum of those claims is yet to be made. AOP Health welcomes this decision. It will continue to supply patients in need of ropeginterferon alfa-2b (BESREMi®). 1 ELN Guideline (2022), NCCN Guideline (2024), Onkopedia Leitlinie (2023) Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: About BESREMi® BESREMi® is the first interferon that was approved for polycythemia vera, a myeloproliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies. BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen. For the EMA Summary of Product Characteristics please visit: BESREMi® AOP Health is a global healthcare group with roots in Austria, where the headquarters of AOP Orphan Pharmaceuticals GmbH ("AOP Health") is located. Since 1996, the AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the fields of rare diseases and intensive care medicine. At the end of 2024, AOP Health received its first U.S. FDA approval for RapiblykTM, a medication aimed at patients in intensive care units, thereby further strengthening its commitment to making therapies available for patients worldwide. The AOP Health Group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners. With the claim "Needs. Science. Trust." the AOP Health Group emphasizes its commitment to research and development, as well as the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of the AOP Health Group’s actions. Mag. Nina Roth, MAS Head of Corporate Communications nina.roth[at]aop-health.com photocredit stock-photo: shutterstock_2012352206

Drug ApprovalPatent InfringementLicense out/in

07 Jan 2025

·pipelinereview.com

PharmaEssentia Announces Positive Topline Phase 3 Data from SURPASS-ET Study Evaluating Ropeginterferon Alfa-2b-njft (P1101) for Essential Thrombocythemia

SURPASS-ET trial achieved its primary endpoint, demonstrating a durable response in 42.9% of participants in the P1101 group versus 6.0% in the comparator group (p=0.0001) Data support our plan to submit for regulatory label expansion for ropeginterferon alfa-2b-njft BURLINGTON, MA, USA I January 06, 2024 I PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced positive topline results from its SURPASS-ET clinical trial of ropeginterferon alfa-2b-njft (P1101) in patients with essential thrombocythemia (ET). The trial achieved its primary endpoint, showing durable hematologic responses in patients treated with P1101 with a manageable safety profile and no treatment-related serious adverse events. Ropeginterferon alfa-2b-njft is currently FDA approved and marketed as BESREMi® and indicated for polycythemia vera (PV). The Company plans to seek a label expansion to include ET. SURPASS-ET Clinical Results Clinical Trial Overview SURPASS-ET ( NCT04285086 ) is a global Phase 3, randomized, open-label, active-controlled clinical trial evaluating the efficacy, safety and tolerability of P1101 versus Anagrelide as a second-line therapy for ET for 12 months. A total of 174 patients were enrolled, with 91 randomly assigned to the P1101 treatment group and 83 to the Anagrelide group. Primary Endpoint Secondary Endpoint: “We are extremely proud of the SURPASS-ET Phase 3 study outcome, which shows the potential of P1101 as an important new treatment option for patients with ET, a rare blood cancer that drastically increases the risk of heart attack or stroke,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “The data highlight the broad potential to apply our innovative monopegylated, long-acting interferon technology as a significant step forward for treating ET, and potentially other myeloproliferative neoplasms, with non-chemotherapy treatments. We plan to leverage these data to expand the existing P1101 product label and further expand the reach of P1101 to address this growing global unmet medical need.” PharmaEssentia plans to present detailed clinical trial results, including additional pharmacokinetics and biomarker data, at a later date. The Company also intends to pursue regulatory discussions with the FDA to expand the existing label for P1101 to include a new potential indication of ET and anticipates regulatory submission by the end of 2025. “The results of the SURPASS-ET trial are significant,” said Albert Qin, M.D., Ph.D., Chief Medical Officer. “ET is a challenging condition associated with symptoms and risks of thrombosis and disease progression. These encouraging results highlight the potential of P1101 to provide an effective and tolerable new treatment option that we believe could provide a substantial clinical benefit for patients with ET. We plan to submit these results to the FDA and other regulatory agencies as soon as possible in hopes of providing this potential new treatment option to patients with ET.” The Company is also evaluating P1101 in ET patients in its EXCEED-ET ( NCT05482971 ) clinical trial in North America. This Phase 2b clinical trial is a single-arm, multicenter trial designed to assess the efficacy, safety, and tolerability of P1101 in adult patients with ET. The company expects to present data from this clinical trial in the second half of 2025. About Essential Thrombocythemia Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism. It is estimated that approximately 148,000 people in the U.S. have ET, which can significantly impact quality of life due to burdensome symptoms. Patients diagnosed with ET face limited treatment options to manage their condition, particularly in reducing the risk of thrombosis and slowing disease progression. About BESREMi® (ropeginterferon alfa-2b-njft) in polycythemia vera (PV) BESREMi is an innovative monopegylated, long-acting interferon with marketing authorization in PV. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information , including Boxed Warning. About PharmaEssentia PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website , LinkedIn or X (formerly Twitter). SOURCE: Pharmaessentia

Clinical ResultDrug ApprovalPhase 2Phase 3

06 Jan 2025

·www.businesswire.com

PharmaEssentia Announces Positive Topline Phase 3 Data from SURPASS-ET Study Evaluating Ropeginterferon Alfa-2b-njft (P1101) for Essential Thrombocythemia

BURLINGTON, Mass.--( BUSINESS WIRE )-- PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced positive topline results from its SURPASS-ET clinical trial of ropeginterferon alfa-2b-njft (P1101) in patients with essential thrombocythemia (ET). The trial achieved its primary endpoint, showing durable hematologic responses in patients treated with P1101 with a manageable safety profile and no treatment-related serious adverse events. Ropeginterferon alfa-2b-njft is currently FDA approved and marketed as BESREMi® and indicated for polycythemia vera (PV). The Company plans to seek a label expansion to include ET. SURPASS-ET Clinical Results Clinical Trial Overview SURPASS-ET ( NCT04285086 ) is a global Phase 3, randomized, open-label, active-controlled clinical trial evaluating the efficacy, safety and tolerability of P1101 versus Anagrelide as a second-line therapy for ET for 12 months. A total of 174 patients were enrolled, with 91 randomly assigned to the P1101 treatment group and 83 to the Anagrelide group. Primary Endpoint The trial successfully met its primary endpoint, demonstrating durable clinical response as measured using modified European Leukemia Net (ELN) criteria. Among the intent-to-treat (ITT) population, 42.9% (39/91) of participants in the P1101 group achieved durable responses at months 9 and 12, compared to 6.0% (5/83) in the comparator arm (administered Anagrelide) (p=0.0001). P1101 exhibited a manageable safety profile with no treatment-related serious adverse events. Secondary Endpoint: The JAK2 V617F allelic burden was assessed at baseline and 12 months, showing a decrease from 33.7% to 25.3% (-8.4% change) in the P1101 group, compared to a reduction from 39.7% to 37.3% (-2.4% change) in the Anagrelide group. These results suggest that P1101 may have a greater impact on addressing the underlying disease pathology compared to Anagrelide. “We are extremely proud of the SURPASS-ET Phase 3 study outcome, which shows the potential of P1101 as an important new treatment option for patients with ET, a rare blood cancer that drastically increases the risk of heart attack or stroke,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “The data highlight the broad potential to apply our innovative monopegylated, long-acting interferon technology as a significant step forward for treating ET, and potentially other myeloproliferative neoplasms, with non-chemotherapy treatments. We plan to leverage these data to expand the existing P1101 product label and further expand the reach of P1101 to address this growing global unmet medical need.” PharmaEssentia plans to present detailed clinical trial results, including additional pharmacokinetics and biomarker data, at a later date. The Company also intends to pursue regulatory discussions with the FDA to expand the existing label for P1101 to include a new potential indication of ET and anticipates regulatory submission by the end of 2025. “The results of the SURPASS-ET trial are significant,” said Albert Qin, M.D., Ph.D., Chief Medical Officer. “ET is a challenging condition associated with symptoms and risks of thrombosis and disease progression. These encouraging results highlight the potential of P1101 to provide an effective and tolerable new treatment option that we believe could provide a substantial clinical benefit for patients with ET. We plan to submit these results to the FDA and other regulatory agencies as soon as possible in hopes of providing this potential new treatment option to patients with ET.” The Company is also evaluating P1101 in ET patients in its EXCEED-ET ( NCT05482971 ) clinical trial in North America. This Phase 2b clinical trial is a single-arm, multicenter trial designed to assess the efficacy, safety, and tolerability of P1101 in adult patients with ET. The company expects to present data from this clinical trial in the second half of 2025. About Essential Thrombocythemia Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism. It is estimated that approximately 148,000 people in the U.S. have ET, which can significantly impact quality of life due to burdensome symptoms. Patients diagnosed with ET face limited treatment options to manage their condition, particularly in reducing the risk of thrombosis and slowing disease progression. About BESREMi® (ropeginterferon alfa-2b-njft) in polycythemia vera (PV) BESREMi is an innovative monopegylated, long-acting interferon with marketing authorization in PV. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information , including Boxed Warning. About PharmaEssentia PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website , LinkedIn or X (formerly Twitter).

Phase 2Clinical ResultPhase 3Drug ApprovalImmunotherapy

100 Deals associated with Ropeginterferon alfa-2b-NJFT

External Link

KEGG	Wiki	ATC	Drug Bank
D11027	Ropeginterferon alfa-2b-NJFT	L03AB15	DB15119

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Polycythemia Vera	Taiwan Province	PharmaEssentia Corp.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Polycythemia Vera	Preclinical	Belgium	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Germany	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Spain	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Romania	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Ukraine	Aop Orphan Pharmaceuticals GmbH	01 Sep 2013
Polycythemia Vera	Preclinical	Czechia	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	France	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Slovakia	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Austria	PharmaEssentia Corp.	01 Sep 2013
Polycythemia Vera	Preclinical	Hungary	PharmaEssentia Corp.	01 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04285086 (EXCEED-ET, Biospace) Manual	Phase 3	Thrombocythemia, Essential Second line	174	P1101 (Ropeginterferon alfa-2b-njft)	(ndvryjjcyb) = gdshrjhhfr ywnprcfjle (gygaekcrjt ) Met View more	Positive	06 Jan 2025
NCT04285086 (EXCEED-ET, Biospace) Manual	Phase 3	Thrombocythemia, Essential Second line	174	Anagrelide	(ndvryjjcyb) = zwqmbxxpet ywnprcfjle (gygaekcrjt ) Met View more	Positive	06 Jan 2025
EHA2024 Manual	Phase 2	Polycythemia Vera JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)	ritpdnqwyo(qoclictrxl) = xjssvdavqm icpilswack (ylnuuzqhcy )	Positive	14 May 2024
EHA2024 Manual	Phase 2	Polycythemia Vera JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)py, STD)	ritpdnqwyo(qoclictrxl) = hcnafdbfqe icpilswack (ylnuuzqhcy )	Positive	14 May 2024
EUCTR2012-005259-18-CZ \| EUCTR2014-001357-17-PL (PROUD-PV, EHA2024) Manual	Phase 3	Polycythemia Vera JAK2V617F allele burden	169	ropeginterferon alfa-2b	xviqemayfk(vptzsvnqjo) = jpggjhadlg iutptjcuxs (clzdiirzkv ) View more	Positive	14 May 2024
	Phase 3	Polycythemia Vera JAK2V617F allele burden	169	HU/BAT	xviqemayfk(vptzsvnqjo) = vezsmqfhuy iutptjcuxs (clzdiirzkv ) View more	Positive	14 May 2024
PROUD-PV/CONTINUATION (EHA2024)	Phase 3	Second line JAK2 mutated	12	Ropeginterferon alfa-2b	(wcccgosatg) = One withdrew therapy due to intolerance (flushing and eczema, grade 1) after 9 months of treatment kurxerdcyz (nlvscbgtah )	Positive	14 May 2024
EHA2024	Phase 3	Polycythemia Vera	34	Ropeginterferon alfa-2b	dmocogevaj(iftelzigvm) = One patient developed autoimmune thyroiditis without the need to suspend treatment mczztnfire (nlmglbwvgf ) View more	Positive	14 May 2024
EHA2024	Phase 2	Polycythemia Vera JAK2 V617F allele burden	27	Ropeginterferon alfa-2b	(btgefcsyas) = Although most patients (25/27 [92.6%]) experienced adverse events (AEs), ropeginterferon alfa-2b was generally well tolerated. The most common AEs were WBC count decreased (7/27 [25.9%]) and urine beta-2 microglobulin increased (6/27 [22.2%]) fpgmhlgvjc (udwljgjygn ) View more	Positive	14 May 2024
P1101MF (ASH2023)	Phase 2	Primary Myelofibrosis	-	Ropeginterferon alfa 2b	troagqhetw(rehyyiixlp) = nqsokdaafw fcjrfutioq (vipdqjkkel ) View more	-	11 Dec 2023
ASH2023	Not Applicable	Polycythemia Vera	99	P1101	(ohvjeitacs) = jwrqtcbude vuqnmljkwa (dpckwjbbeh ) View more	-	11 Dec 2023
PROUD-PV/CONTINUATION-PV (ASH2023)	Not Applicable	Polycythemia Vera	-	Ropeginterferon alfa-2b	(ijekawblpc) = ydqskqnxnf xczjsyiyfe (nshyzqjzjc )	-	11 Dec 2023
CTR20211664 \| NCT05485948 (Pubmed 1 \| Pubmed 2 \| Exp Hematol Oncol) Manual	Phase 2	Polycythemia Vera	49	ropeginterferon alfa-2b	(xqjkuqldkl) = jezyjibgnx jdumumepkm (ldilyndsdi ) View more	Positive	21 Jun 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis