This section highlights FDA-related milestones and regulatory updates for drugs developed by Protagonist Therapeutics (PTGX).
Over the past two years, Protagonist Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
JNJ-2113, PN-881, and Rusfertide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
JNJ-2113 - FDA Regulatory Timeline and Events
JNJ-2113 is a drug developed by Protagonist Therapeutics for the following indication: Severely Active Ulcerative Colitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JNJ-2113
- Announced Date:
- March 10, 2025
- Indication:
- Severely Active Ulcerative Colitis
Announcement
Protagonist Therapeutics, Inc. announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
Protagonist Therapeutics, Inc. announced positive topline results from the ANTHEM-UC Phase 2b study evaluating icotrokinra (JNJ-2113), the first investigational targeted oral peptide to selectively block the IL-23 receptor. The study involved adults with moderately to severely active ulcerative colitis. All three doses tested met the primary endpoint, with the highest dose achieving a clinical response rate of 63.5% at Week 12, compared to 27.0% in the placebo group. Additionally, at this dose, 30.2% of patients reached clinical remission versus 11.1% for placebo. The safety profile was favorable, and clinical remission and response rates continued to improve through Week 28. These promising results indicate that icotrokinra has the potential to transform the treatment landscape for ulcerative colitis, offering a new and convenient once-daily oral treatment option for patients suffering from this chronic inflammatory condition.
Read Announcement- Drug:
- JNJ-2113
- Announced Date:
- March 8, 2025
- Indication:
- Severely Active Ulcerative Colitis
Announcement
Protagonist Therapeutics announced new icotrokinra (JNJ-2113) data from the comprehensive Phase 3 clinical program and the planned initiation of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.
AI Summary
Protagonist Therapeutics recently announced encouraging new data for icotrokinra (JNJ-2113) from its comprehensive Phase 3 clinical program in moderate‐to‐severe plaque psoriasis (PsO). In the ICONIC-LEAD study, nearly half of patients achieved completely clear skin at Week 24, demonstrating significant skin clearance and a favorable safety profile in both adults and adolescents. Based on these promising results and additional positive outcomes from comparisons with another oral therapy, the company, in collaboration with Johnson & Johnson, is moving forward with a groundbreaking Phase 3 study—ICONIC-ASCEND. This upcoming head-to-head trial will be the first to compare an oral pill, icotrokinra, directly against an injectable biologic, ustekinumab, in patients with plaque psoriasis, aiming to prove the superiority of the pill. If successful, the study could offer a more convenient treatment option and potentially shift the current psoriasis therapy landscape.
Read Announcement
PN-881 - FDA Regulatory Timeline and Events
PN-881 is a drug developed by Protagonist Therapeutics for the following indication: oral peptide antagonist blocking the three dimeric forms of IL-17.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PN-881
- Announced Date:
- May 9, 2025
- Indication:
- oral peptide antagonist blocking the three dimeric forms of IL-17
Announcement
Protagonist Therapeutics, Inc announced new clinical data from the Phase 3 ICONIC-TOTAL a study investigating icotrokinra, the first-in-class oral peptide antagonist targeting IL-23 receptor and preclinical characterization of PN-881, the first-in-class oral peptide antagonist blocking the three dimeric forms of IL-17 (AA, AF and FF), were presented separately today at the 2025 Society for Investigative Dermatology (SID) Annual Meeting in San Diego, CA.
AI Summary
Protagonist Therapeutics, Inc. presented new clinical data from the Phase 3 ICONIC-TOTAL study and preclinical findings on PN-881 at the 2025 Society for Investigative Dermatology Annual Meeting in San Diego, CA. The ICONIC-TOTAL study evaluated icotrokinra, a first-in-class oral peptide antagonist targeting the IL-23 receptor, in patients with plaque psoriasis. Notably, 66% of patients with scalp psoriasis and 77% with genital psoriasis achieved clear or almost clear skin at Week 16. Icotrokinra also demonstrated significant overall skin clearance combined with a favorable safety profile when taken as a once-daily pill.
In parallel, preclinical data for PN-881—an oral peptide antagonist that blocks all three dimeric forms of IL-17 (AA, AF, and FF)—showed high potency, metabolic stability, and effective dose-dependent skin inflammation reduction in animal models. This advancement supports further human clinical studies planned for Q4 2025.
Read Announcement
Rusfertide (PTG-300) - FDA Regulatory Timeline and Events
Rusfertide (PTG-300) is a drug developed by Protagonist Therapeutics for the following indication: Polycythemia vera (PV).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Rusfertide (PTG-300)
- Announced Date:
- June 1, 2025
- Indication:
- Polycythemia vera (PV)
Announcement
Protagonist Therapeutics, Inc and Takeda announced detailed results from the Phase 3, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints.
AI Summary
Protagonist Therapeutics, Inc and Takeda recently announced the detailed results from the Phase 3, randomized, placebo-controlled VERIFY study, which evaluated rusfertide in patients with polycythemia vera (PV). The study met its primary endpoint, with 76.9% of patients receiving rusfertide plus standard of care achieving a clinical response—defined by the absence of phlebotomy eligibility—versus 32.9% on placebo. All key secondary endpoints were also met, including a nearly three-fold reduction in the proportion of patients needing phlebotomy and a four-fold improvement in hematocrit control in the rusfertide arm compared to placebo. These outcomes were consistently observed across both high- and low-risk patient groups, regardless of whether they were also on concomitant cytoreductive therapy. Overall, the study shows promising clinical benefits of rusfertide for PV patients, improving treatment response and patient-reported outcomes.
Read Announcement- Drug:
- Rusfertide (PTG-300)
- Announced Date:
- March 3, 2025
- Indication:
- Polycythemia vera (PV)
Announcement
Protagonist Therapeutics, Inc and Takeda announced positive topline results for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment.
AI Summary
Protagonist Therapeutics, Inc. and Takeda announced positive topline results from the Phase 3 VERIFY study. The trial evaluated rusfertide, a first-of-its-kind hepcidin mimetic peptide, in patients with polycythemia vera (PV) who depend on regular phlebotomy. In this randomized study, patients received either rusfertide or a placebo as an add-on to their standard care treatment.
The study met its primary endpoint, showing a significantly higher percentage of clinical responders in the rusfertide group (77%) compared to the placebo group (33%) during weeks 20 to 32. In addition, all four key secondary endpoints were achieved, including reductions in phlebotomy needs and improvements in patient-reported outcomes. Rusfertide was generally well tolerated, with most adverse events being mild to moderate injection site reactions and no new safety concerns observed during the trial.
Read Announcement- Drug:
- Rusfertide (PTG-300)
- Announced Date:
- December 9, 2024
- Indication:
- Polycythemia vera (PV)
Announcement
Protagonist Therapeutics, announced details from a poster presentation with final data from the rusfertide Phase 2 REVIVE study.
AI Summary
Protagonist Therapeutics recently shared final data from the rusfertide Phase 2 REVIVE study during a poster presentation at the 66th American Society of Hematology Annual Meeting. The study evaluated rusfertide, a mimetic of the natural hormone hepcidin, in treating polycythemia vera (PV). Results showed that 54% of patients maintained hematocrit levels below 45% for over 2.5 years, allowing for significantly reduced phlebotomy use. The study consisted of multiple parts, with patients undergoing a dose-finding phase, a blinded withdrawal phase, and an open-label extension. The final data indicate that rusfertide, when used alongside therapeutic phlebotomy (with or without cytoreductive therapy), provides durable control of hematocrit levels and improves patient-reported outcomes. Additionally, the treatment was generally well-tolerated, supporting its potential as a first-in-class option for managing PV. Future studies will further evaluate its long-term safety and effectiveness.
Read Announcement- Drug:
- Rusfertide (PTG-300)
- Announced Date:
- June 14, 2024
- Indication:
- Polycythemia vera (PV)
Announcement
Protagonist Therapeutics, Inc. 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.
AI Summary
Protagonist Therapeutics, Inc. recently shared details at the European Hematology Association 2024 Congress from two new abstracts. One key presentation highlighted long-term follow-up data from the Phase 2 REVIVE study that tested rusfertide, a hepcidin mimetic with potential to treat polycythemia vera and other conditions. The study results showed that patients experienced durable control of hematocrit levels below 45% for up to three years, along with a significant decrease in phlebotomy use. Additionally, the treatment demonstrated long-term tolerability with no new safety signals, as most side effects were mild injection site reactions. Patients completing the Phase 2 study now have the opportunity to enroll in the THRIVE study, extending their treatment for an additional two years. These findings point to rusfertide’s growing potential as an effective long-term treatment option for polycythemia vera.
Read Announcement
Free PTGX Stock Alerts