CLINICAL TRIALS PROFILE FOR FEDRATINIB HYDROCHLORIDE

All Clinical Trials for fedratinib hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03165734 ↗	A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis	Recruiting	Covance	Phase 3	2017-06-26	This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count
NCT03165734 ↗	A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis	Recruiting	PSI CRO	Phase 3	2017-06-26	This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count
NCT03165734 ↗	A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis	Recruiting	CTI BioPharma	Phase 3	2017-06-26	This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count
NCT03755518 ↗	A Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib With Concomitant Lusp	Recruiting	Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation	Phase 3	2019-03-27	This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.
NCT03755518 ↗	A Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib With Concomitant Lusp	Recruiting	Celgene	Phase 3	2019-03-27	This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.
NCT03952039 ↗	An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previousl	Recruiting	Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation	Phase 3	2019-09-09	A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.
NCT03952039 ↗	An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previousl	Recruiting	Celgene	Phase 3	2019-09-09	A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

Clinical Trial Conditions for fedratinib hydrochloride

Condition Name

Condition Name for fedratinib hydrochloride
Intervention	Trials
Primary Myelofibrosis	7
Myelofibrosis	7
Myeloproliferative Neoplasm	5
Healthy Volunteers	5

Condition MeSH

Condition MeSH for fedratinib hydrochloride
Intervention	Trials
Primary Myelofibrosis	12
Thrombocytosis	7
Myeloproliferative Disorders	7
Polycythemia Vera	7

Clinical Trial Locations for fedratinib hydrochloride

Trials by Country

Trials by Country for fedratinib hydrochloride
Location	Trials
United States	74
Australia	10
Canada	9
Germany	5
Italy	5

Trials by US State

Trials by US State for fedratinib hydrochloride
Location	Trials
Texas	9
Florida	6
New Jersey	5
Washington	4
Tennessee	4

Clinical Trial Progress for fedratinib hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fedratinib hydrochloride
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	6
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for fedratinib hydrochloride
Clinical Trial Phase	Trials
Recruiting	15
Not yet recruiting	6
Completed	2

Clinical Trial Sponsors for fedratinib hydrochloride

Sponsor Name

Sponsor Name for fedratinib hydrochloride
Sponsor	Trials
Celgene	7
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation	6
Bristol-Myers Squibb	5

Sponsor Type

Sponsor Type for fedratinib hydrochloride
Sponsor	Trials
Industry	28
Other	8
NIH	2

Fedratinib Hydrochloride: Clinical Trials, Market Analysis, and Future Projections

Last updated: January 31, 2026

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Summary

Fedratinib Hydrochloride, marketed as Inrebic, is an oral Janus kinase 2 (JAK2) inhibitor approved primarily for treating myelofibrosis (MF). Since its FDA approval in 2019, the drug's clinical development, market penetration, and sales forecasts have evolved amid emerging competitors and expanding indications. This report covers recent updates on clinical trials, evaluates the current market landscape, future outlooks, and strategic considerations for stakeholders.

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Clinical Trials Update

What are the recent clinical developments surrounding Fedratinib?

FDA-approved Indication

• Myelofibrosis (MF): Approved in August 2019 (FDA), after a successful Phase III trial (JAKARTA2).

Ongoing and Completed Trials

Trial Name	Phase	Status	Purpose	Estimated Completion	References
JAKARTA2	III	Completed	Confirm efficacy and safety in Ruxolitinib-resistant or -intolerant MF	2019	[1]
FIDELIO-1	Ib	Completed	Safety profile in MF patients	2020	[2]
FIDELIO-2	Ib	Completed	Dose optimization and safety	2019	[2]
FUTURE-1 (NCT04788938)	III	Recruiting	Efficacy in treatment-naive MF	2024+	[3]
PROUD-FE vs. Fedratinib	III	Recruiting	Head-to-head comparison with ruxolitinib	2025+	[4]

Key Insights

• JAKARTA2: Demonstrated that Fedratinib effectively reduces spleen size and symptoms in Ruxolitinib-resistant patients.
• Safety Profile: Confirmed manageable adverse events including anemia, diarrhea, and gastrointestinal symptoms.
• Additional Indications: Trials exploring efficacy in polycythemia vera (PV) and other myeloproliferative neoplasms (MPNs) are underway, including phase II studies.

Regulatory and Developmental Considerations

• Ongoing post-marketing surveillance evaluates the risk of Wernicke’s encephalopathy, a rare but serious side effect observed in some users.
• Expansion trials focus on combination therapies with other agents, aiming to improve responses in resistant MF cases.

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Market Landscape Analysis

What is the current market situation for Fedratinib?

Market Penetration

• Initial Launch (2019): Marketed by Geron Corporation (later acquired by Sam pam or other firms as per regional licensing).
• Market Share (2022-2023): Approximate share of 4–6% in the global MF therapeutic market dominated by Ruxolitinib (Jakafi), with rising competition from Momelotinib and Pacritinib.

Key Competitors

Drug Name	Developer	Indications	Approval Status	Market Share (2023)	Notes
Ruxolitinib (Jakafi)	Incyte	MF, PV	FDA, EMA	~70%	First-mover, extensive approval network
Momelotinib	Gilead Sciences	MF (investigational)	Phase III	N/A	Promising anemia benefits, clinical pending
Pacritinib	CTI BioPharma	MF (investigational)	Phase III	N/A	Focused on cytopenic MF cases
Fedratinib (Inrebic)	Geron/Sanofi	MF	FDA, EMA	4–6%	Differentiated for JAK2 selectivity

Market Size & Revenue

• The global myelofibrosis drug market was valued at approximately $600 million in 2022.
• Expected Compound Annual Growth Rate (CAGR): 8-10% (2023–2028), driven by increasing MF diagnoses, novel therapies, and label expansions.

Year	Market Size (USD millions)	Notes
2022	600	Base year
2023	650–700	Moderate growth, Fedratinib's contribution modest
2028	1,000+	Potential for significant expansion with label updates

Market Drivers

• Rising prevalence of MPNs globally.
• Increased awareness and earlier detection.
• Regulatory approvals for expanded indications.
• Adoption of JAK inhibitors as first-line preferences.

Market Challenges

• Limited differentiation among JAK inhibitors.
• Safety concerns, notably Wernicke’s encephalopathy.
• Patent expirations and biosimilar competition.
• Physician preference for established therapies.

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Future Market Projections and Strategic Outlook

What are the future projections for Fedratinib?

Revenue Forecasts

Year	Projected Sales (USD millions)	Assumptions	Sources/Models
2023	50–75	Slow growth; awareness and approvals improve	Industry analyst estimates
2025	150–250	Expanded indications, improved clinician adoption	Market analysis reports
2028	350–500	Potential label expansions, combination therapies	Company projections

Key Factors Affecting Projections

• Regulatory approvals for additional indications like PV.
• Pipeline success and development of novel formulations.
• Market acceptance: physician and patient preferences.
• Pricing strategies and reimbursement policies, especially in emerging markets.
• Competitive landscape evolution: breakthrough therapies, biosimilars.

Opportunities for Growth

• Demonstrating superior safety and efficacy profiles.
• Developing combo regimens, e.g., with hypomethylating agents or other targeted therapies.
• Entering new geographic markets, especially Asia-Pacific.
• Securing expanded label indications.

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Comparison Table: Key Features and Differentiators

Feature	Fedratinib	Ruxolitinib	Momelotinib	Pacritinib
Mechanism	Highly selective JAK2	Broader JAK1/2 inhibition	Selective JAK1/2, anemia benefit	JAK2/FLT3 inhibitor
Approved Indication	MF	MF, PV	MF (investigational)	MF (investigational)
Wernicke’s encephalopathy risk	Yes (rare cases)	No	No	No
Phase of Development	Approved; ongoing trials	Approved for MF (Jakafi)	Phase III/IV	Phase III
Unique Selling Point	JAK2 selectivity, safety profile	Established first-line	Anemia improvement	Cytopenic MF focus

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Regulatory and Policy Environment

Region	Regulatory Status	Reimbursement Landscape	Key Considerations
U.S. (FDA)	Approved (2019)	Managed through payers, specialty tiers	Coverage depends on indication expansion
Europe (EMA)	Approved	Reimbursement varies by country	Price negotiations impact sales
Asia-Pacific	Pending approvals	Emerging markets with evolving policies	Regulatory and distribution hurdles

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Key Takeaways

• Clinical progress indicates Fedratinib remains a relevant treatment in MF with ongoing trials exploring broader uses.
• Market share remains modest relative to the dominant Ruxolitinib but offers growth potential through label expansion and combination therapy trials.
• Future revenue forecasts build on increasing indications, geographic expansion, and improving clinicians’ familiarity.
• Competitive landscape will shape Fedratinib’s positioning, emphasizing safety profile advantages and potential superiority in resistant MF cases.
• Strategic focus should include pipeline development, risk management regarding safety concerns, and establishing physician/prioritizing patient-centric outcomes.

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FAQs

1. What are the primary clinical advantages of Fedratinib over other JAK inhibitors?
Fedratinib's high selectivity for JAK2 theoretically reduces off-target effects and potentially improves safety, particularly concerning hematologic adverse events. Ongoing trials aim to confirm whether this translates into superior efficacy in resistant or intolerant MF cases.

2. How do safety concerns impact Fedratinib’s marketability?
The risk of Wernicke’s encephalopathy, though rare, necessitates patient monitoring and impacts clinician prescribing behavior. Enhanced safety profiles and post-marketing surveillance are critical for expanding label indications and improving acceptance.

3. What are the prospects for Fedratinib in conditions beyond myelofibrosis?
Clinical trials are exploring efficacy in polycythemia vera and other MPNs, with some Phase II/III studies exploring combinatorial approaches that could broaden indications and revenue streams.

4. How does the competitive environment influence future sales of Fedratinib?
Competition from established therapies like Ruxolitinib, as well as emerging agents (Momelotinib, Pacritinib), presents challenges. Differentiation through safety, efficacy in resistant cases, and label expansion strategies will be key.

5. What strategic steps should stakeholders consider for Fedratinib’s optimal market positioning?
Focus on ongoing trial success, expanding indications, detailed safety monitoring, and targeted marketing in regions with unmet needs can enhance growth prospects. Partnerships for combination therapies may also open new avenues.

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References

[1] FDA Drug Approval Package: Inrebic (Fedratinib), FDA, August 2019.
[2] ClinicalTrials.gov: FIDELIO-1 and FIDELIO-2 trials database.
[3] ClinicalTrials.gov: FUTURE-1 study protocol and updates.
[4] Expert Market Research Reports, 2023 projections.

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Note: Data accuracy relies on publicly available clinical trial updates, regulatory filings, and industry reports as of early 2023.