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Asset Brief

SNT-5505 (amsulostat)

SNT·Syntara·Myelofibrosis (a bone marrow cancer that disrupts normal blood cell production)·Phase 2·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Myelofibrosis is a type of bone marrow cancer in which scar tissue gradually replaces healthy marrow, impairing the production of normal blood cells. Patients commonly experience an enlarged spleen, fatigue, and other debilitating symptoms. The disease can arise on its own or develop from a related blood disorder, and it carries a meaningful risk of transforming into acute leukaemia. Standard treatment options remain limited, and many patients do not respond adequately to existing therapies.
What the asset is trying to do: SNT-5505 (amsulostat) is classified as a kinase inhibitor, meaning it works by blocking one or more enzymes (kinases) involved in driving disease activity. The specific molecular target of amsulostat is not disclosed in the materials available for this brief. The asset is being evaluated both as a standalone therapy and in combination with ruxolitinib, a JAK (Janus kinase) inhibitor that is already approved for myelofibrosis, suggesting a potential role in patients who require additional disease control on top of existing treatment.
What the trial is measuring, and why it matters: The Phase 2 programme is assessing amsulostat in both a monotherapy arm and a combination arm with ruxolitinib. Interim data have shown reductions in spleen volume and improvements in symptom scores, which are standard measures used to assess treatment activity in myelofibrosis trials. Spleen volume reduction and symptom burden are established endpoints in this disease area because an enlarged spleen and constitutional symptoms are primary sources of morbidity. Full endpoint details for the lead trial are not available in the materials provided for this brief.
Efficacy benchmarks in this setting: In the pivotal COMFORT-I trial, ruxolitinib (Jakafi) achieved a spleen volume reduction of 35% or more in 41.9% of patients with myelofibrosis at 24 weeks, compared with 0.7% for placebo (per Verstovsek et al, New England Journal of Medicine, 2012). In the PERSIST-2 trial, pacritinib (Vonjo) achieved a spleen volume reduction of 35% or more in 29% of patients receiving the approved 200 mg twice-daily dose versus 3% for best available therapy (per Mascarenhas et al, JAMA Oncology, 2018). Fedratinib (Inrebic) achieved spleen volume reduction of 35% or more in 47% of patients in the JAKARTA trial (per Harrison et al, Journal of Clinical Oncology, 2020). Interim figures reported for amsulostat come from an early-stage, non-randomised context and are not statistically comparable to these registrational trial results.

Trial Design

Design summary

Phase: Phase 2
Design type: [ TODO: fill in ] Phase 2 study evaluating amsulostat as monotherapy and in combination with ruxolitinib in myelofibrosis patients.
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: [ TODO: fill in ]
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ]

Asset Track Record

Did SNT deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

5 July 2026data readoutEncouraging SNT-4728 Phase 2 iRBD resultshit · positivesrc ASX ↗
30 June 2026regulatory decisionEMA Orphan Drug Designation decision (MF)overdue
30 June 2026regulatory decisionFDA feedback on myelofibrosis development planoverdueASX ↗
30 June 2026data readoutPhase 2 MF combo (ruxolitinib) efficacy data readoutoverdueASX ↗
10 June 2026financingResults of Share Purchase Planhitsrc ASX ↗
14 May 2026financingUpdate - Proposed issue of securities - SNThitsrc ASX ↗
13 May 2026financingShare Purchase Plan Offer Booklethitsrc ASX ↗
28 Apr 2026regulatory decisionAmsulostat (SNT-5505) FDA — Positive FDA feedback for Amsulostat P2b trialhit · positivesrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for SNT-5505 (amsulostat) and peers

SNT-5505 (amsulostat)'s own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for SNT-5505 (amsulostat). Showing past 6 months and next 12 months · 12 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Study of Canakinumab in Patients With Myelofibrosis

Trial design comparison

How SNT-5505 (amsulostat) reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
SNT-5505 (amsulostat)	Syntara	Kinase Inhibitor	Phase 2[ TODO: fill in ]	[ TODO: fill in ] Phase 2 study evaluating amsulostat as monotherapy and in combination with ruxolitinib in myelofibrosis patients.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
CINC424A2X01B Rollover Protocol

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

Kinase InhibitorASX peers ›

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for SNT-5505 (amsulostat) yet. Broker coverage of Syntara is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did SNT deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

5 July 2026data readoutEncouraging SNT-4728 Phase 2 iRBD resultshit · positivesrc ASX ↗
30 June 2026regulatory decisionEMA Orphan Drug Designation decision (MF)overdue
30 June 2026regulatory decisionFDA feedback on myelofibrosis development planoverdueASX ↗
30 June 2026data readoutPhase 2 MF combo (ruxolitinib) efficacy data readoutoverdueASX ↗
10 June 2026financingResults of Share Purchase Planhitsrc ASX ↗
14 May 2026financingUpdate - Proposed issue of securities - SNThitsrc ASX ↗
13 May 2026financingShare Purchase Plan Offer Booklethitsrc ASX ↗
28 Apr 2026regulatory decisionAmsulostat (SNT-5505) FDA — Positive FDA feedback for Amsulostat P2b trialhit · positivesrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for SNT-5505 (amsulostat) and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Study of Canakinumab in Patients With Myelofibrosis

Trial design comparison

How SNT-5505 (amsulostat) reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
SNT-5505 (amsulostat)	Syntara	Kinase Inhibitor	Phase 2[ TODO: fill in ]	[ TODO: fill in ] Phase 2 study evaluating amsulostat as monotherapy and in combination with ruxolitinib in myelofibrosis patients.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
CINC424A2X01B Rollover Protocol

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

Kinase InhibitorASX peers ›

SNT-5505 (amsulostat)n = 0

Syntara·Kinase Inhibitor·Phase 2·[ TODO: fill in ]

Design: [ TODO: fill in ] Phase 2 study evaluating amsulostat as monotherapy and in combination with ruxolitinib in myelofibrosis patients.
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

CINC424A2X01B Rollover Protocoln = —

Novartis Pharmaceuticals·Kinase Inhibitor·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Countsn = —

SWOG Cancer Research Network·Kinase Inhibitor·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)n = —

Novartis Pharmaceuticals·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosisn = —

AbbVie·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expressionn = —

Dartmouth-Hitchcock Medical Center·Allogeneic Cell Therapy Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusionsn = —

Celgene·Fc Fusion Protein·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosisn = —

Karyopharm Therapeutics Inc·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosisn = —

Swedish Orphan Biovitrum·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinibn = —

Kartos Therapeutics, Inc.·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Riskn = —

PharmaEssentia·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosisn = —

Chengdu Zenitar Biomedical Technology Co., Ltd·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trialsn = —

Celgene·Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)n = —

Novartis Pharmaceuticals·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatmentn = —

Geron Corporation·Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)n = —

Merck Sharp & Dohme LLC·Kinase Inhibitor·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Luspatercept in Preventing Poor Erythroid Engraftment for Hematological Malignancies With Moderate to Severe Myelofibrosisn = —

Nanfang Hospital, Southern Medical University·Other·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Decitabine in Treating Patients With Myelofibrosisn = —

National Cancer Institute (NCI)·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemian = —

National Cancer Institute (NCI)·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Myelofibrosis Treated With Pacritinib Before aSCT. (HOVON134MF)n = —

Stichting Hemato-Oncologie voor Volwassenen Nederland·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosisn = —

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosisn = —

Galecto Biotech AB·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Ruxolitinib vs Allogeneic SCT for Patients With Myelofibrosis According to Donor Availabilityn = —

Universitätsklinikum Hamburg-Eppendorf·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosisn = —

National Taiwan University Hospital·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosisn = —

Telios Pharma, Inc.·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxisn = —

Center for International Blood and Marrow Transplant Research·Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosisn = —

Fred Hutchinson Cancer Center·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosisn = —

Chengdu Zenitar Biomedical Technology Co., Ltd·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantsn = —

City of Hope Medical Center·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosisn = —

Ryvu Therapeutics SA·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinibn = —

Incyte Corporation·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Canakinumab in Patients With Myelofibrosisn = —

John Mascarenhas·Monoclonal antibody·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosisn = —

Karyopharm Therapeutics Inc·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasmsn = —

University of Washington·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasmsn = —

Italfarmaco·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosisn = —

The University of Hong Kong·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)n = —

Icahn School of Medicine at Mount Sinai·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Extended Access of Momelotinib in Adults With Myelofibrosisn = —

GlaxoSmithKline·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasmsn = —

University of Southern California·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegalyn = —

M.D. Anderson Cancer Center·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosisn = —

Memorial Sloan Kettering Cancer Center·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosisn = —

GlaxoSmithKline·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosisn = —

Fred Hutchinson Cancer Center·Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trialn = —

Icahn School of Medicine at Mount Sinai·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenian = —

Karyopharm Therapeutics Inc·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenian = —

Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosisn = —

Chengdu Zenitar Biomedical Technology Co., Ltd·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)n = —

National Cancer Institute (NCI)·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosisn = —

M.D. Anderson Cancer Center·Monoclonal antibody·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosisn = —

Takeda·Fc Fusion Protein·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosisn = —

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Kinase Inhibitor·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

N
CINC424A2X01B Rollover Protocol
Phase 4
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 16 Sept 2027·NCT02386800
SC
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Phase 4
SWOG Cancer Research Network·Not yet recruiting·Primary completion 8 Aug 2029·NCT07498205
SO
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Phase 3
Swedish Orphan Biovitrum·Active, not recruiting·Primary completion 5 Oct 2026·NCT03165734
K,
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Phase 3
Kartos Therapeutics, Inc.·Recruiting·Primary completion 31 Dec 2026·NCT06479135
P
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Phase 3
PharmaEssentia·Recruiting·Primary completion 30 Sept 2027·NCT06468033
CZ
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
Phase 3
Chengdu Zenitar Biomedical Technology Co., Ltd·Recruiting·Primary completion 30 Dec 2027·NCT07317700
N
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Phase 3
Novartis Pharmaceuticals·Recruiting·Primary completion 17 May 2028·NCT07357727
MS
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Phase 3
Merck Sharp & Dohme LLC·Recruiting·Primary completion 4 Dec 2034·NCT06351631
SH
Myelofibrosis Treated With Pacritinib Before aSCT. (HOVON134MF)
Phase 2
Stichting Hemato-Oncologie voor Volwassenen Nederland·Active, not recruiting·Primary completion 1 July 2023·NCT03645824
CT
A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis
Phase 2
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Active, not recruiting·Primary completion 15 Oct 2023·NCT05020652
GB
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis
Phase 2
Galecto Biotech AB·Active, not recruiting·Primary completion 31 Dec 2023·NCT04679870
UH
Ruxolitinib vs Allogeneic SCT for Patients With Myelofibrosis According to Donor Availability
Phase 2
Universitätsklinikum Hamburg-Eppendorf·Active, not recruiting·Primary completion 7 Oct 2024·NCT03333187
TP
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Phase 2
Telios Pharma, Inc.·Recruiting·Primary completion 30 June 2025·NCT04655118
FH
Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis
Phase 2
Fred Hutchinson Cancer Center·Active, not recruiting·Primary completion 3 Apr 2026·NCT04384692
CZ
A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis
Phase 2
Chengdu Zenitar Biomedical Technology Co., Ltd·Recruiting·Primary completion 6 May 2026·NCT06457425
CO
Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants
Phase 2
City of Hope Medical Center·Active, not recruiting·Primary completion 22 May 2026·NCT05364762
RS
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
Phase 2
Ryvu Therapeutics SA·Recruiting·Primary completion 1 June 2026·NCT06397313
IC
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Phase 2
Incyte Corporation·Active, not recruiting·Primary completion 22 June 2026·NCT04640025
UO
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
Phase 2
University of Washington·Recruiting·Primary completion 11 Nov 2026·NCT04282187
I
Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms
Phase 2
Italfarmaco·Active, not recruiting·Primary completion 1 Dec 2026·NCT01761968
TU
Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
Phase 2
The University of Hong Kong·Recruiting·Primary completion 1 Dec 2026·NCT06770842
IS
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
Phase 2
Icahn School of Medicine at Mount Sinai·Recruiting·Primary completion 1 Dec 2026·NCT05835466
G
Extended Access of Momelotinib in Adults With Myelofibrosis
Phase 2
GlaxoSmithKline·Active, not recruiting·Primary completion 11 Dec 2026·NCT03441113
MA
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Phase 2
M.D. Anderson Cancer Center·Recruiting·Primary completion 1 Jan 2027·NCT06345495
MS
A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis
Phase 2
Memorial Sloan Kettering Cancer Center·Active, not recruiting·Primary completion 1 Feb 2027·NCT03069326
G
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Phase 2
GlaxoSmithKline·Recruiting·Primary completion 19 Mar 2027·NCT06517875
GE
Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia
Phase 2
Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas·Not yet recruiting·Primary completion 1 Dec 2027·NCT07394153
CZ
A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis
Phase 2
Chengdu Zenitar Biomedical Technology Co., Ltd·Recruiting·Primary completion 30 Dec 2027·NCT07443306
CT
A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
Phase 2
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Not yet recruiting·Primary completion 1 June 2028·NCT07551427

Small Molecule OtherASX peers ›

11 activeexpand ›

N
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Phase 3
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 23 Aug 2023·NCT04603495
A
Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
Phase 3
AbbVie·Active, not recruiting·Primary completion 29 Jan 2025·NCT04468984
KI
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Phase 3
Karyopharm Therapeutics Inc·Active, not recruiting·Primary completion 20 Feb 2026·NCT04562389
NC
Decitabine in Treating Patients With Myelofibrosis
Phase 2
National Cancer Institute (NCI)·Active, not recruiting·Primary completion 1 July 2008·NCT00095784
NC
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
Phase 2
National Cancer Institute (NCI)·Active, not recruiting·Primary completion 31 May 2023·NCT03289910
NT
Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis
Phase 2
National Taiwan University Hospital·Recruiting·Primary completion 12 Oct 2024·NCT05731245
KI
A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis
Phase 2
Karyopharm Therapeutics Inc·Active, not recruiting·Primary completion 1 Sept 2026·NCT04562870
UO
Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
Phase 2
University of Southern California·Recruiting·Primary completion 31 Dec 2026·NCT06063486
IS
MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
Phase 2
Icahn School of Medicine at Mount Sinai·Recruiting·Primary completion 1 June 2027·NCT06541249
KI
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Phase 2
Karyopharm Therapeutics Inc·Recruiting·Primary completion 1 June 2027·NCT05980806
NC
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
Phase 2
National Cancer Institute (NCI)·Recruiting·Primary completion 31 Dec 2027·NCT06661915

Fc Fusion ProteinASX peers ›

2 activeexpand ›

Class profileexpand ›

Description

Recombinant proteins that fuse a target-binding domain to an antibody Fc region, which extends half-life and aids purification. In retinal disease the dominant example is aflibercept (Eylea), a VEGF "trap" that sequesters VEGF-A and placental growth factor, delivered by intravitreal injection. Sozinibercept (OPT-302, Opthea) is a VEGF-C / VEGF-D trap designed to be added on top of standard anti-VEGF-A therapy to block the compensatory VEGF-C/D escape pathway, rather than used as a standalone agent.

Class benchmarks

The anti-VEGF biologic/Fc-fusion class is among the most commercially proven in medicine: aflibercept (Eylea and Eylea HD) and the bispecific faricimab (Vabysmo) anchor a multi-billion-dollar wet-AMD and diabetic macular oedema market alongside ranibizumab (Lucentis). Efficacy is read in best-corrected visual acuity (BCVA letter gain) and anatomic (retinal thickness) endpoints, and the current competitive frontier is durability — stretching the dosing interval to 12-16 weeks to cut injection burden. Sozinibercept's thesis is incremental letter gain on top of an anti-VEGF-A backbone; its pivotal Phase 3 programme (ShORe / COAST) is the gating readout for the combination approach.

Commercial track record

The commercial moat sits with the incumbents (Regeneron/Bayer, Roche/Novartis) through entrenched prescribing, biosimilar defence and durability positioning. A combination agent must show a clinically meaningful BCVA benefit over an already-effective monotherapy to justify a second injection and incremental cost — a high commercial bar even when the mechanism is sound.

Capital intensity

Standard recombinant biologic manufacturing; cost-of-goods is modest relative to price. The dominant economics are the size of the wet-AMD/DME market and the injection-burden dynamic, not production cost. Biosimilar entry on aflibercept is now compressing class pricing.

Regulatory posture

A well-templated path — BCVA non-inferiority or superiority versus an approved comparator on established precedent, with anatomic secondary endpoints. The specific risk for a combination add-on is that regulators and payers demand a clear incremental benefit over anti-VEGF-A monotherapy, so a numerically positive but small effect may clear approval yet struggle commercially.

Class sources (4)

Eylea (aflibercept) prescribing information · FDA · accessed 29 May 2026
Vabysmo (faricimab) prescribing information · FDA · accessed 29 May 2026
Opthea — sozinibercept (OPT-302) ShORe / COAST Phase 3 program · Opthea · accessed 29 May 2026
Wykoff CC et al — anti-VEGF durability in retinal disease (Ophthalmology review) · Ophthalmology · accessed 29 May 2026

C
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
Phase 3
Celgene·Active, not recruiting·Primary completion 26 May 2025·NCT04717414
T
A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Phase 2
Takeda·Recruiting·Primary completion 28 Feb 2028·NCT05037760