The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

Start Date22 Jan 2024

Sponsor / Collaborator

Protagonist Therapeutics, Inc.

NCT05210790 / RecruitingPhase 3

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Start Date01 Apr 2022

Sponsor / Collaborator

Protagonist Therapeutics, Inc.

NCT04767802 / CompletedPhase 2

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)

This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.

Start Date02 Feb 2021

Sponsor / Collaborator

Protagonist Therapeutics, Inc.

100 Clinical Results associated with Rusfertide acetate

100 Translational Medicine associated with Rusfertide acetate

100 Patents (Medical) associated with Rusfertide acetate

Literatures (Medical) associated with Rusfertide acetate

01 Dec 2023·The lancet. Gastroenterology & hepatology

Rusfertide for the treatment of iron overload in HFE-related haemochromatosis: an open-label, multicentre, proof-of-concept phase 2 trial

Article

Author: Peltekian, Kevork ; Gupta, Suneel ; Modi, Nishit B ; Valone, Frank H ; Vierling, John M ; Kowdley, Kris V ; Ferris, Christopher

BACKGROUND:

Hereditary haemochromatosis protein (HFE)-related haemochromatosis, an inherited iron overload disorder caused by insufficient hepcidin production, results in excessive iron absorption and tissue and organ injury, and is treated with first-line therapeutic phlebotomy. We aimed to investigate the efficacy and safety of rusfertide, a peptidic mimetic of hepcidin, in patients with HFE-related haemochromatosis.

METHODS:

This open-label, multicentre, proof-of-concept phase 2 trial was done across nine academic and community centres in the USA and Canada. Adults (aged ≥18 years) with HFE-related haemochromatosis on a stable therapeutic phlebotomy regimen (maintenance phase) for at least 6 months before screening and who had a phlebotomy frequency of at least 0·25 per month (eg, at least three phlebotomies in 12 months or at least four phlebotomies in 15 months) and less than one phlebotomy per month, with serum ferritin of less than 300 ng/mL and haemoglobin of more than 11·5 g/dL, were eligible. Patients initiated 24 weeks of subcutaneous rusfertide treatment within 7 days of a scheduled phlebotomy at 10 mg once weekly. Rusfertide doses and dosing schedules could be adjusted to maintain serum transferrin iron saturation (TSAT) at less than 40%. During rusfertide treatment, investigators were to consider the need for phlebotomy when the serum ferritin and TSAT values exceeded the patient's individual pre-phlebotomy serum ferritin and TSAT values. No primary endpoint or testing hierarchy was prespecified. Prespecified efficacy endpoints included the change in the frequency of phlebotomies; the proportion of patients achieving phlebotomy independence; change in serum iron, TSAT, serum transferrin, serum ferritin, and liver iron concentration (LIC) as measured by MRI; and treatment-emergent adverse events (TEAEs). The key efficacy analyses for phlebotomy rate and LIC were conducted by use of paired t tests in the intention-to-treat population, defined as all patients who received any study drug and who had pretreatment and at least one post-dose measurement. We included all participants who received at least one dose of rusfertide in the safety analyses. This trial is closed and completed and is registered with ClinicalTrials.gov, NCT04202965.

FINDINGS:

Between March 11, 2020, and April 23, 2021, 28 patients were screened and 16 (ten [63%] men and six [38%] women) were enrolled. 16 were included in analyses of phlebotomy endpoints and 14 for the LIC endpoint. 12 (75%) patients completed 24 weeks of treatment. The mean number of phlebotomies was significantly reduced during the 24-week rusfertide treatment (0·06 phlebotomies [95% CI -0·07 to 0·20]) compared with 24 weeks pre-study (2·31 phlebotomies [95% CI 1·77 to 2·85]; p<0·0001). 15 (94%) of 16 patients were phlebotomy-free during the treatment period. Mean LIC in the 14 patients in the intention-to-treat population was 1·4 mg iron per g dry liver weight (95% CI 1·0 to 1·8) at screening and 1·1 mg iron per g dry liver weight (95% CI 0·9 to 1·3) at the end of treatment (p=0·068). Mean TSAT was 45·3% (95% CI 33·2 to 57·3) at screening, 36·7% (24·2 to 49·2) after the pretreatment phlebotomy, 21·8% (15·8 to 27·9) 24 h after the first dose of rusfertide, 40·4% (27·1 to 53·8) at the end of treatment, and 32·6% (25·0 to 40·1) over the treatment duration. Mean serum iron was 24·6 μmol/L (95% CI 18·6 to 30·6), 20·1 μmol/L (14·8 to 25·3), 11·9 μmol/L (9·2 to 14·7), 22·5 μmol/L (15·9 to 29·1), and 19·0 μmol/L (15·3 to 22·6) at these same timepoints, respectively. Mean serum ferritin was 83·3 μg/L (52·2 to 114.4), 65·5 μg/L (32·1 to 98·9), 62·8 μg/L (33·8 to 91·9), 150·0 μg/L (86·6 to 213.3), and 94·3 μg/L (54·9 to 133.6) at these same timepoints, respectively. There were only minor changes in serum transferrin concentration. 12 (75%) patients had at least one TEAE, the most common of which was injection site pain (five [31%] patients). All TEAEs were mild or moderate in severity, except for a serious adverse event of pancreatic adenocarcinoma, which was considered severe and unrelated to treatment and was pre-existing and diagnosed 21 days after starting rusfertide treatment.

INTERPRETATION:

Rusfertide prevents iron re-accumulation in the absence of phlebotomies and could be a viable therapeutic option for selected patients with haemochromatosis.

FUNDING:

Protagonist Therapeutics.

01 Mar 2023·Current opinion in hematology

Hepcidin mimetics in polycythemia vera: resolving the irony of iron deficiency and erythrocytosis

Review

Author: Ginzburg, Yelena ; Handa, Shivani ; Hoffman, Ronald ; Kremyanskaya, Marina

Purpose of review:

Development of hepcidin therapeutics has been a ground-breaking discovery in restoring iron homeostasis in several haematological disorders. The hepcidin mimetic, rusfertide, is in late-stage clinical development for treating polycythemia vera patients with a global phase 3 trial [NCT05210790] currently underway. Rusfertide serves as the first possible noncytoreductive therapeutic option to maintain haematocrit control and avoid phlebotomy in polycythemia vera patients. In this comprehensive review, we discuss the pathobiology of dysregulated iron metabolism in polycythemia vera, provide the rationale for targeting the hepcidin-ferroportin axis and elaborate on the preclinical and clinical trial evidence supporting the role of hepcidin mimetics in polycythemia vera.

Recent findings:

Recently, updated results from two phase 2 clinical trials [NCT04057040 & NCT04767802] of rusfertide (PTG300) demonstrate that the drug is highly effective in eliminating the need for therapeutic phlebotomies, normalizing haematological parameters, repleting iron stores and relieving constitutional symptoms in patients with polycythemia vera. In light of these findings, additional hepcidin mimetic agents are also being evaluated in polycythemia vera patients.

Summary:

Hepcidin agonists essentially serve as a ‘chemical phlebotomy’ and are poised to vastly improve the quality of life for phlebotomy requiring polycythemia vera patients.

01 Oct 2022·Clinical lymphoma, myeloma & leukemia

MPN-469 Rusfertide (PTG-300) Treatment Interruption Reverses Hematological Gains and Upon Reinitiation, Restoration of Clinical Benefit Observed in Patients With Polycythemia Vera

Article

Author: Modi, Nishit ; O'Connor, Paula ; Verstovsek, Srdan ; Gotlib, Jason ; Ginzburg, Yelena ; Gupta, Suneel ; Palmer, Jeanne ; Ritchie, Ellen ; Kremyanskaya, Marina ; Valone, Frank ; Pemmaraju, Naveen ; Gerds, Aaron ; Kuykendall, Andrew ; Hoffman, Ronald

CONTEXT:

Polycythemia vera (PV) patients are routinely treated with periodic therapeutic phlebotomy (TP) alone or combined with cytoreductive therapy to maintain hematocrit (HCT) <45% and reduce the incidence of thrombosis. TP may not adequately control HCT and results in iron deficiency. Rusfertide, a hepcidin mimetic, eliminates phlebotomy requirements and improves iron deficiency. We examined the impact of rusfertide dosing interruption on TP requirements, HCT, and iron homeostasis in 2 studies during FDA-mandated clinical hold in response to pre-clinical and clinical safety findings.

DESIGN AND PATIENTS:

The REVIVE study (NCT04057040), in phlebotomy-dependent PV patients consisted of 3 parts: (1) 28-week dose-finding; (2) 12-week blinded randomized withdrawal (1:1) rusfertide vs placebo; and (3) 52-week open-label extension. The PACIFIC study (NCT04767802) in PV patients with high HCT (>48%), consisted of 2 parts, (1) Induction with 40mg SQ twice weekly until HCT<45%, and (2) Continuation, typically with weekly dosing.

INTERVENTIONS:

Subcutaneous rusfertide 10-120 mg weekly added to the existing regimen and adjusted to maintain HCT <45%. During treatment interruption, patients received their baseline cytoreductive regimens with TP to maintain HCT <45%.

MAIN OUTCOME MEASURES:

Iron homeostasis, HCT control, and TP requirements.

RESULTS:

In the REVIVE study, all participants were essentially phlebotomy free, HCTs maintained at <45%, and ferritin normalized, when rusfertide was added to their treatment. In the PACIFIC study, participants with an average baseline HCT of 51% had their HCT reduced to and maintained at <45% within ~6 weeks of treatment initiation. When a clinical hold necessitated rusfertide dosing interruption, participants had significant (p<0.01) increases in TPs, HCT, and RBC count, and a decrease in serum ferritin. Reinitiating rusfertide normalized hematologic parameters, eliminated TP, and restored ferritin demonstrating the potential effectiveness of rusfertide. Most adverse events (AEs) were grade 1-2. The most frequent AEs were transient injection site reactions reported in 59% of participants.

CONCLUSIONS:

Rusfertide maintains HCT at <45%, essentially eliminates TP requirements, and reverses iron deficiency in PV patients with/without cytoreductive agents. Reversal of hematological parameters during dosing interruption further confirms the effect of rusfertide on erythrocytosis and iron homeostasis. A global Phase 3 trial, VERIFY (NCT05210790), has been initiated.

News (Medical) associated with Rusfertide acetate

14 Jun 2024

·www.biospace.com

Protagonist Reports Updated Long Term Results from Rusfertide Phase 2 REVIVE Study at the EHA2024 Congress Showing Durable Hematocrit Control

Long term follow-up from REVIVE Phase 2 study up to 3 years shows durable hematocrit (Hct) control (< 45%), decreased phlebotomy use, long-term tolerability, and no new safety signals in patients with polycythemia vera Patients receiving rusfertide in the open-label extension of the REVIVE study are eligible to roll over to the THRIVE study for an additional 2 years of treatment NEWARK, CA / ACCESSWIRE / June 14, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced details from two abstracts at the European Hematology Association 2024 Congress, including an oral presentation with long-term follow-up data from the Phase 2 REVIVE study with rusfertide, a mimetic of the natural hormone hepcidin with potential therapeutic value in the treatment of polycythemia vera (PV) and other disease indications. Copies of the presentations will be available on the Events and Presentations section of the Protagonist website. Kristen M. Pettit, M.D., Clinical Associate Professor at University of Michigan Health presented the long-term follow-up data from patients in REVIVE who continued into the open label extension (OLE). The Phase 2 trial consisted of 3 parts including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the placebo-controlled, randomized withdrawal Part 2 (13 weeks), and 58 patients in the Part 3 OLE (52 weeks). The THRIVE study provides OLE for an additional two years of treatment to patients who have completed Part 3 OLE of the Phase 2 REVIVE study. As of April 9, 2024 (data cut-off for the EHA presentation), 47 patients (81.0%) remain on rusfertide, with 48 patients treated for two or more years and 10 patients treated for three or more years. Of the 58 patients who entered the REVIVE Part 3 OLE, the median duration of therapy is 124.3 weeks as of the April 9, 2024 data cut-off, and 24 patients have rolled over to the THRIVE study for up to two additional years of rusfertide treatment. "These long-term REVIVE data continue to showcase the positive clinical impact that rusfertide has on PV patients," noted Dr. Kristen M. Pettit. "With up to three years of data showing strong and lasting improvements in hematocrit as well as previous evidence of symptom improvement, rusfertide continues to demonstrate its potential as an important future treatment option for patients with polycythemia vera." The updated long-term data showed that rusfertide when added to therapeutic phlebotomy with or without cytoreductive therapy resulted in: Long term durable control of hematocrit below the 45% threshold for up to 3 years Decreased phlebotomy use, from a rate of 8.7 per year before study entry to 0.43 per year in Part 3 of REVIVE, which remained consistent with the rate of 0.36 per year observed for patients randomized to rusfertide in Part 2 of REVIVE Decreased red blood cell counts and continued improvement and normalization of serum ferritin levels Mean leukocyte counts remained stable throughout the study; an asymptomatic increase in platelets was observed with initiation of rusfertide treatment but stabilized over time No new safety signals with the majority of adverse events being Grade 1-2 injection site reactions or adverse events consistent with the comorbidities commonly associated with polycythemia vera In REVIVE, 19 of 70 patients (27.1%) had a history of cancer prior to enrolling in the study. Among these, 10 (14.3%) had a history of skin cancer. As of April 9, 2024, there are 11 patients diagnosed with malignancies while on study (11/70; 15.7%), including 9 with skin cancer (9/70; 12.9%). All cancers occurred in patients with risk factors such as a prior history of cancer, previous cytoreductive therapy, pre-existing skin lesions that were not biopsied or photosensitive skin. All skin cancers were localized, early stage (in situ or stage 1) and all patients remained on rusfertide after the skin lesions were excised. "The long-term open label rusfertide data from REVIVE study continue to show a durable positive effect on PV symptomology and other benefits including iron deficiency as well as a solid safety profile. Patients completing the 3-year open-label extension can roll over to the THRIVE open-label study for an additional 2-years providing efficacy and safety for a total of up to 5.8 years of rusfertide treatment," said Arturo Molina, M.D., M.S., Chief Medical Officer of Protagonist. "We are very pleased with the continued favorable safety pro look forward to the top-line data for the VERIFY Phase 3 study's 32-week primary efficacy endpoint by the end of the first quarter of 2025." A separate abstract accepted for publication only was titled "Absence of QTC Prolongation with Rusfertide, a Hepcidin Mimetic for the Treatment of Polycythemia Vera: A Thorough QT/QTC Study in Healthy Subjects." In this study, 60 healthy subjects were randomized to receive single doses of subcutaneous rusfertide (90mg), matching placebo, or oral moxifloxacin (400mg).Rusfertide was generally well tolerated and did not result in a clinically relevant prolongation of the QTcF interval. About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024 and became effective in March 2024. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833 500 0061 SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com

Clinical ResultPhase 3Phase 2License out/in

31 May 2024

·www.biospace.com

Protagonist Therapeutics to Participate in the Jefferies Global Healthcare Conference 2024

NEWARK, CA / ACCESSWIRE / May 31, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in a fireside chat and one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York City on June 4-6, 2024. Jefferies Global Healthcare Conference Format: Fireside Chat Day/Time: Wednesday, June 5 at 11:00-11:25 A.M. EDT Location: Track 9 Webcast: Link HERE If you are interested in meeting with the Protagonist team during the conference, please reach out to your Jefferies representative. A replay of the fireside chat will be available for 90 days and published to the Events & Presentations section of the Protagonist corporate website: . About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Johnson & Johnson scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Johnson & Johnson Innovative Medicine and followed it through IND-enabling pre-clinical and Phase 1 studies, with Johnson & Johnson assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were published in The New England Journal of Medicine in February 2024. The open-label extension component of Phase 2 is ongoing, as is the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Media Contact Virginia Amann, Founder/CEO ENTENTE Network of Companies virginiaamann@ententeinc.com SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com

Phase 3Phase 2License out/in

14 May 2024

·www.biospace.com

Protagonist Therapeutics Announces Oral Presentation on Long-Term Follow-up of Rusfertide Phase 2 REVIVE Study Open Label Extension at the European Hematology Association 2024 Congress

NEWARK, CA / ACCESSWIRE / May 14, 2024 / Protagonist Therapeutics, Inc., (NASDAQ:PTGX) ("Protagonist" or the "Company") today announced that additional data from the rusfertide Phase 2 REVIVE open label extension study will be the focus of an oral presentation at the European Hematology Association (EHA) Congress being held in Madrid, Spain from June 13-16, 2024. There will also be a published abstract showing the absence of QTc prolongation with rusfertide based on the results from the thorough QT/QTc study conducted in healthy subjects. EHA Presentation Details: Oral Presentation Title: Updated Long-Term Results from the Phase 2 Revive Study Investigating the Hepcidin Mimetic Rusfertide in Polycythemia Vera Patients (Pts): Hematocrit Control and Therapeutic Phlebotomy (Tp) Frequency. Presenter: Kristen M. Pettit, MD, Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA. Date and Time of Conference Session: Friday, June 14th, 2024, 14:45 - 16:00 CEST; Hall Goya 2 EHA Published Abstract Details: Oral Presentation Title: Absence of QTc Prolongation with Rusfertide, a Hepcidin Mimetic for the Treatment of Polycythemia Vera: a Thorough QT/QTc Study in Healthy Subjects. Lead Author: Nishit Modi, SVP of Clinical Pharmacology, Protagonist Therapeutics About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. The agreement will be effective upon the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833 500 0061 SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com

Phase 2Phase 3License out/inClinical ResultPhase 1

100 Deals associated with Rusfertide acetate

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polycythemia Vera	Phase 3	US	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	AU	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	AT	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	BE	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	CA	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	CL	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	CZ	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	FR	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	DE	Protagonist Therapeutics, Inc.	01 Apr 2022
Polycythemia Vera	Phase 3	HK	Protagonist Therapeutics, Inc.	01 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04057040 (REVIVE, EHA2024) Manual	Phase 2	Polycythemia Vera	70	Rusfertide	jdavfdlyxp(mbyapdytqc) = Platelets increased by approximately 30% post-baseline within 4 weeks following initiation of rusfertide therapy aomlplidbi (sbnasqwmlc ) View more	Positive	14 May 2024
				Placebo
NCT04057040 (REVIVE, EHA2024)	Phase 2	Polycythemia Vera	70	rusfertide	udvidwtkvb(edyyzkukue) = Grade 3 TEAEs occurred in 24.3% of pts pyboezhufe (lvslaxftsk ) View more	Positive	14 May 2024
				placebo
NCT04057040 (REVIVE, Literature) Manual	Phase 2	Polycythemia Vera	70	Rusfertide	anvssjkyuf(kvfqnykjbg) = gljpqkkyce vkvybirxiu (uznnyxcxxy ) Met	Positive	22 Feb 2024
NCT04767802 (PACIFIC \| REVIVE, Biospace) Manual	Phase 2	Polycythemia Vera	70	Rusfertide	uadefdqwbp(jgotmoydii) = qphywmkgfd yxpnsgjqws (oxrswwnjgb )	Positive	12 Dec 2023
				Rusfertide	uadefdqwbp(jgotmoydii) = fddxknnqoy yxpnsgjqws (oxrswwnjgb )
NCT04202965 (CTgov)	Phase 2	Hemochromatosis	16	PTG-300	toojkmmvpn(jaziobkmxc) = gwnyvtnjvk zwztsmndny (zyqwrhoywa, nftnrhvaye - ppnybxczgx) View more	-	15 Jun 2023
NCT04057040 (ASH2022) Manual	Phase 2	Polycythemia Vera	70	rusfertide+TP	ftqilejcbl(itpinqrqji) = kuzdfmgitm ixotpjqptg (jkvbxypkvr ) View more	Positive	15 Nov 2022
				rusfertide+TP+CYR-T	ftqilejcbl(itpinqrqji) = xhehnpqoqo ixotpjqptg (jkvbxypkvr ) View more
NCT04767802 \| NCT04057040 (ASCO2022)	Phase 2	Polycythemia Vera	-	Rusfertide (PTG-300)	mzxjklhzbk(wrbhdhfjwf) = mostly grade 1-2 adverse events (AE). These were typically transient, manageable with topical therapies, and did not lead to study withdrawal. pjwpxwbltv (dlkwtmpgra ) View more	Positive	02 Jun 2022
NCT04057040 (PRNewswire) Manual	Phase 2	Polycythemia Vera	63	Rusfertide	wumvpmwkye(gmzrvsfada) = essentially eliminated vorzqhrvde (nhtgklwjet ) View more	Positive	11 Jun 2021

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