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Asset Brief

DMX-200

DXB·Dimerix·IgA nephropathy (IgAN) — a progressive kidney disease caused by abnormal antibody deposits in the kidneys·Phase 3·NCT05183646·Primary completion: 1 Dec 2029

Plain-language Brief

The trial in plain terms

The disease: IgA nephropathy (IgAN) is a chronic kidney disease in which deposits of immunoglobulin A (IgA), an antibody, accumulate in the small filtering units of the kidneys. Over time, this triggers inflammation and scarring that progressively reduces kidney function. It is one of the most common forms of primary glomerulonephritis (kidney inflammation) worldwide. Without effective treatment, a meaningful proportion of patients progress to kidney failure requiring dialysis or transplant.
What the asset is trying to do: DMX-200 is described by Dimerix as a GPCR (G protein-coupled receptor) modulator. The trial registry records DMX-200 as an investigational agent administered alongside an ARB (angiotensin receptor blocker), which is a standard-of-care blood-pressure and kidney-protective medication (per ClinicalTrials.gov NCT05183646). The rationale for combining a GPCR modulator with an ARB relates to targeting complementary pathways involved in kidney inflammation and fibrosis, though the precise molecular target for DMX-200 is not disclosed in available public sources.
What the trial is measuring, and why it matters: The trial is measuring efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are already receiving an ARB (per ClinicalTrials.gov NCT05183646). Note that the registered condition is FSGS, a related but distinct kidney disease to IgAN; both conditions involve progressive loss of kidney filtering function and share some clinical endpoints. The primary endpoint and key secondary endpoints are not fully detailed in the available registry data.
Efficacy benchmarks in this setting: In IgAN, approved therapies provide a benchmark for kidney-protective efficacy. Sparsentan (Filspari), approved by the FDA in 2023 for IgAN, demonstrated a reduction in urine protein-to-creatinine ratio (UPCR) of approximately 41% versus irbesartan at nine months in the PROTECT trial (per Travere Therapeutics PROTECT trial data, NEJM 2023). Budesonide delayed-release (Tarpeyo/Nefecon), also FDA-approved for IgAN, showed a reduction in proteinuria (protein in urine) of approximately 27% versus placebo at nine months in the NefIgArd trial (per Calliditas Therapeutics NefIgArd trial data). More recently, iptacopan (Fabhalta) received FDA approval for IgAN in 2024 based on proteinuria reduction data (per Novartis prescribing information). Early-stage figures from DMX-200 studies are not statistically comparable to these pivotal trial results, which were conducted in larger, randomised populations under different conditions.
Commercial context: The IgAN treatment landscape has seen several regulatory approvals in the United States since 2023, including sparsentan, budesonide delayed-release, and iptacopan, meaning DMX-200 would enter a market with existing approved options if it reaches that stage (per respective FDA approval announcements). The lead trial registered on ClinicalTrials.gov (NCT05183646) targets 286 patients and lists FSGS rather than IgAN as the primary condition, which is a distinct regulatory consideration. Dimerix announced that the last patient received their first dose in the ACTION3 Phase 3 trial in March 2026 (per ASX announcement, 2026-03-09). Dimerix also disclosed that a statistical review of the ACTION3 trial's assumptions was conducted and completed in early 2026 (per ASX announcements, 2026-03-15 and 2026-04-27). No licensing, partnership, or commercialisation deal terms have been disclosed in the available announcements.

Sources for this brief (5)

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB (ACTION3) · ClinicalTrials.gov · accessed 15 June 2026
Sparsentan versus Irbesartan in IgA Nephropathy (PROTECT trial) · New England Journal of Medicine / Travere Therapeutics · accessed 15 June 2026
Targeted-release formulation of budesonide in IgA nephropathy (NefIgArd trial) · New England Journal of Medicine / Calliditas Therapeutics · accessed 15 June 2026
Fabhalta (iptacopan) FDA Approval for IgA Nephropathy · Novartis / U.S. Food and Drug Administration · accessed 15 June 2026
Dimerix ASX Announcements · Australian Securities Exchange (ASX) · accessed 15 June 2026

Trial Design

Design summary

Phase: Phase 3
Design type: Randomised, placebo-controlled study. Patients receive DMX-200 or placebo on a background of ARB therapy (per ClinicalTrials.gov NCT05183646).
Primary endpoint: [ TODO: fill in — not specified in available registry data ]
Key secondary endpoints: Safety and tolerability (per ClinicalTrials.gov NCT05183646)
[ TODO: fill in additional secondary endpoints from full protocol ]
Enrolment target: 286 patients (per ClinicalTrials.gov NCT05183646)
Current enrolment status: Recruiting; last patient received first dose reported March 2026 (per ASX announcement 2026-03-09)
Sites: [ TODO: fill in — site countries and number not specified in available data ]
Expected readout window: Primary completion is listed as 2029-12-01 on ClinicalTrials.gov (NCT05183646); interim or topline data windows have not been disclosed in the available announcements.

Asset Track Record

Did DXB deliver against its own guidance?

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

22 July 2026regulatory decisionDMX-652 USPTO — US Patent Granted for Dimerix New Asset DMX-652hit · positivesrc
16 July 2026data readoutDimerix Expands Pipeline with Acquisition of Phase 2 Assethit · positivesrc ASX ↗
8 July 2026otherDMX-200 Available To Patients Via Post-Trial Access Pathwayshitsrc ASX ↗
16 June 2026otherDimerix Licenses DMX200 to Everest for China and Asia Regionhitsrc ASX ↗
30 Apr 2026data readoutACTION3 Blinded Statistical Assumptions Review — Results Due April 2026hitsrc ASX ↗
9 Mar 2026data readoutDimerix Phase 3 Trial Last Patient Receives First Dosehit · positivesrc

Class Catalyst Calendar

What's landed, what's next for DMX-200 and peers

DMX-200'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 DMX-200. Showing past 6 months and next 12 months · 10 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Trial design comparison

How DMX-200 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
DMX-200	Dimerix	Gpcr Modulator	Phase 3[ TODO: fill in ]	Randomised, placebo-controlled study. Patients receive DMX-200 or placebo on a background of ARB therapy (per ClinicalTrials.gov NCT05183646).	[ TODO: fill in — not specified in available registry data ]	[ TODO: fill in ]	286 patients (per ClinicalTrials.gov NCT05183646)	286
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

Competitor Landscape

Competing programmes by mechanism and phase

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

Mechanism trade-offs· 2 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)
Antisense oligonucleotideASO	Off-the-shelf	Synthetic	Approved (SMA/DMD)	Chronic dosing	Moderate

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 DMX-200 yet. Broker coverage of Dimerix 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 DXB deliver against its own guidance?

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

22 July 2026regulatory decisionDMX-652 USPTO — US Patent Granted for Dimerix New Asset DMX-652hit · positivesrc
16 July 2026data readoutDimerix Expands Pipeline with Acquisition of Phase 2 Assethit · positivesrc ASX ↗
8 July 2026otherDMX-200 Available To Patients Via Post-Trial Access Pathwayshitsrc ASX ↗
16 June 2026otherDimerix Licenses DMX200 to Everest for China and Asia Regionhitsrc ASX ↗
30 Apr 2026data readoutACTION3 Blinded Statistical Assumptions Review — Results Due April 2026hitsrc ASX ↗
9 Mar 2026data readoutDimerix Phase 3 Trial Last Patient Receives First Dosehit · positivesrc

Class Catalyst Calendar

What's landed, what's next for DMX-200 and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Trial design comparison

How DMX-200 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
DMX-200	Dimerix	Gpcr Modulator	Phase 3[ TODO: fill in ]	Randomised, placebo-controlled study. Patients receive DMX-200 or placebo on a background of ARB therapy (per ClinicalTrials.gov NCT05183646).	[ TODO: fill in — not specified in available registry data ]	[ TODO: fill in ]	286 patients (per ClinicalTrials.gov NCT05183646)	286
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

Competitor Landscape

Competing programmes by mechanism and phase

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

Mechanism trade-offs· 2 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)
Antisense oligonucleotideASO	Off-the-shelf	Synthetic	Approved (SMA/DMD)	Chronic dosing	Moderate

DMX-200n = 286

Dimerix·Gpcr Modulator·Phase 3·[ TODO: fill in ]

Design: Randomised, placebo-controlled study. Patients receive DMX-200 or placebo on a background of ARB therapy (per ClinicalTrials.gov NCT05183646).
Primary endpoint: [ TODO: fill in — not specified in available registry data ]
Dosing: [ TODO: fill in ]
Eligibility: 286 patients (per ClinicalTrials.gov NCT05183646)

Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathyn = —

Calliditas Therapeutics AB·Gpcr Modulator·Phase 4

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

Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.n = —

Fondazione Schena·Other·Phase 4

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

Nefecon and Ambrisentan in IgA Nephropathyn = —

The First Hospital of Jilin University·Gpcr Modulator·Phase 4

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

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosisn = —

Travere Therapeutics, Inc.·Gpcr Modulator·Phase 4

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

Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trialn = —

Nanfang Hospital, Southern Medical University·Small Molecule Other·Phase 4

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

Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?n = —

Christian Medical College, Vellore, India·Other·Phase 4

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

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathyn = —

Travere Therapeutics, Inc.·Gpcr Modulator·Phase 3

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

Atacicept in Subjects With IgA Nephropathyn = —

Vera Therapeutics, Inc.·Fc Fusion Protein·Phase 3

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

To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathyn = —

The Affiliated Hospital of Xuzhou Medical University·Fc Fusion Protein·Phase 3

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

Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKDn = —

Air Force Military Medical University, China·Other·Phase 3

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

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)n = —

Alexion Pharmaceuticals, Inc.·Monoclonal antibody·Phase 3

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

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)n = —

Otsuka Pharmaceutical Development & Commercialization, Inc.·Monoclonal antibody·Phase 3

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

A Study of Telitacicept for IgA Nephropathy (TELIGAN)n = —

RemeGen Co., Ltd.·Fc Fusion Protein·Phase 3

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

Effect of Finerenone in IgA Nephropathyn = —

Zhejiang University·Small Molecule Other·Phase 3

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

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progressionn = —

Hoffmann-La Roche·Antisense oligonucleotide·Phase 3

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

A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinurian = —

Biocity Biopharmaceutics Co., Ltd.·Gpcr Modulator·Phase 3

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

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)n = —

Biogen·Monoclonal antibody·Phase 3

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

Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritisn = —

Guixia Ding·Fc Fusion Protein·Phase 3

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

A Study of Zigakibart in Adults With IgA Nephropathyn = —

Novartis Pharmaceuticals·Monoclonal antibody·Phase 3

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

A Trial of HRS-5965 Capsule in Primary IgA Nephropathyn = —

Chengdu Suncadia Medicine Co., Ltd.·Gpcr Modulator·Phase 3

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

Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgANn = —

Haisco Pharmaceutical Group Co., Ltd.·Small Molecule Other·Phase 3

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

Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)n = —

Alpine Immune Sciences Inc, A Subsidiary of Vertex·Fc Fusion Protein·Phase 3

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

Atrasentan in Patients With IgA Nephropathyn = —

Novartis Pharmaceuticals·Gpcr Modulator·Phase 3

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

Study of Ravulizumab in Pediatric Participants With Primary IgANn = —

Alexion Pharmaceuticals, Inc.·Monoclonal antibody·Phase 3

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

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathyn = —

Takeda·Monoclonal antibody·Phase 3

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

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgANn = —

Novartis Pharmaceuticals·Small Molecule Other·Phase 3

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

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathyn = —

Novartis Pharmaceuticals·Small Molecule Other·Phase 3

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

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.n = —

Novartis Pharmaceuticals·Other·Phase 3

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

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgANn = —

Novartis Pharmaceuticals·Gpcr Modulator·Phase 3

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

Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRDn = —

Guang'anmen Hospital of China Academy of Chinese Medical Sciences·Other·PHASE2/PHASE3

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

Study of Telitacicept in Patients With Refractory IgA Nephropathyn = —

Second Affiliated Hospital, School of Medicine, Zhejiang University·Fc Fusion Protein·PHASE2/PHASE3

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

Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)n = —

Otsuka Pharmaceutical Development & Commercialization, Inc.·Monoclonal antibody·PHASE2/PHASE3

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

Atrasentan in Patients With Proteinuric Glomerular Diseasesn = —

Novartis Pharmaceuticals·Gpcr Modulator·Phase 2

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

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Diseasen = —

Biocity Biopharmaceutics Co., Ltd.·Small Molecule Other·Phase 2

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

A Trial of HRS-5965 Tablets in Primary IgA Nephropathyn = —

Chengdu Suncadia Medicine Co., Ltd.·Gpcr Modulator·Phase 2

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

A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathyn = —

University of Leicester·Gpcr Modulator·Phase 2

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

Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgANn = —

Haisco Pharmaceutical Group Co., Ltd.·Small Molecule Other·Phase 2

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

A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathyn = —

Hansoh BioMedical R&D Company·Gpcr Modulator·Phase 2

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

Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritisn = —

Kira Pharmacenticals (US), LLC.·Gpcr Modulator·Phase 2

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

Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)n = —

Wuhan Createrna Science and Technology Co., Ltd·Gpcr Modulator·Phase 2

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

A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseasesn = —

Suzhou Sanegene Bio Inc.·Small Molecule Other·Phase 2

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

Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathyn = —

Nanjing Chia-tai Tianqing Pharmaceutical·Small Molecule Other·Phase 2

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

Monthly Dosing of Atacicept in IgANn = —

Vera Therapeutics, Inc.·Fc Fusion Protein·Phase 2

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

Study of WAL0921 in Patients With Glomerular Kidney Diseasesn = —

Walden Biosciences·Small Molecule Other·Phase 2

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

Study of CM313 in Subject With IgA Nephropathyn = —

Keymed Biosciences Co.Ltd·Gpcr Modulator·Phase 2

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

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseasesn = —

Travere Therapeutics, Inc.·Gpcr Modulator·Phase 2

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

A Study of SHR-2173 in Participants With Primary IgA Nephropathyn = —

Guangdong Hengrui Pharmaceutical Co., Ltd·Gpcr Modulator·Phase 2

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

Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathyn = —

Keymed Biosciences Co.Ltd·Small Molecule Other·Phase 2

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

Atacicept in Multiple Glomerular Diseasesn = —

Vera Therapeutics, Inc.·Fc Fusion Protein·Phase 2

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

Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgANn = —

Novartis Pharmaceuticals·Other·Phase 2

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

CA
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Phase 4
Calliditas Therapeutics AB·Recruiting·Primary completion 29 May 2026·NCT06712407
TF
Nefecon and Ambrisentan in IgA Nephropathy
Phase 4
The First Hospital of Jilin University·Recruiting·Primary completion 31 Dec 2026·NCT07030894
T,
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Phase 4
Travere Therapeutics, Inc.·Active, not recruiting·Primary completion 1 Mar 2027·NCT07219121
T,
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Phase 3
Travere Therapeutics, Inc.·Active, not recruiting·Primary completion 7 Aug 2023·NCT03762850
BB
A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
Phase 3
Biocity Biopharmaceutics Co., Ltd.·Recruiting·Primary completion 31 Dec 2026·NCT06819826
CS
A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
Phase 3
Chengdu Suncadia Medicine Co., Ltd.·Recruiting·Primary completion 1 Oct 2027·NCT07014826
N
Atrasentan in Patients With IgA Nephropathy
Phase 3
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 14 Apr 2028·NCT04573478
N
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Phase 3
Novartis Pharmaceuticals·Recruiting·Primary completion 15 Sept 2031·NCT07498335
N
Atrasentan in Patients With Proteinuric Glomerular Diseases
Phase 2
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 2 July 2024·NCT04573920
CS
A Trial of HRS-5965 Tablets in Primary IgA Nephropathy
Phase 2
Chengdu Suncadia Medicine Co., Ltd.·Active, not recruiting·Primary completion 1 Dec 2024·NCT06137768
UO
A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy
Phase 2
University of Leicester·Active, not recruiting·Primary completion 31 Mar 2025·NCT04663204
HB
A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy
Phase 2
Hansoh BioMedical R&D Company·Not yet recruiting·Primary completion 1 Dec 2025·NCT06635772
KP
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Phase 2
Kira Pharmacenticals (US), LLC.·Not yet recruiting·Primary completion 1 Mar 2026·NCT05517980
WC
Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
Phase 2
Wuhan Createrna Science and Technology Co., Ltd·Not yet recruiting·Primary completion 15 June 2026·NCT06687174
KB
Study of CM313 in Subject With IgA Nephropathy
Phase 2
Keymed Biosciences Co.Ltd·Not yet recruiting·Primary completion 1 Mar 2027·NCT06830395
T,
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
Phase 2
Travere Therapeutics, Inc.·Recruiting·Primary completion 12 Mar 2027·NCT05003986
GH
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
Phase 2
Guangdong Hengrui Pharmaceutical Co., Ltd·Not yet recruiting·Primary completion 1 Apr 2027·NCT07354932

Small Molecule OtherASX peers ›

11 activeexpand ›

NH
Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial
Phase 4
Nanfang Hospital, Southern Medical University·Not yet recruiting·Primary completion 1 Dec 2028·NCT07604311
ZU
Effect of Finerenone in IgA Nephropathy
Phase 3
Zhejiang University·Not yet recruiting·Primary completion 8 June 2026·NCT06580288
HP
Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
Phase 3
Haisco Pharmaceutical Group Co., Ltd.·Recruiting·Primary completion 1 Dec 2027·NCT07390123
N
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
Phase 3
Novartis Pharmaceuticals·Recruiting·Primary completion 28 June 2030·NCT06994845
N
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Phase 3
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 4 Dec 2030·NCT04557462
BB
A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease
Phase 2
Biocity Biopharmaceutics Co., Ltd.·Active, not recruiting·Primary completion 30 Nov 2024·NCT05687890
HP
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN
Phase 2
Haisco Pharmaceutical Group Co., Ltd.·Recruiting·Primary completion 23 Nov 2025·NCT06670352
SS
A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases
Phase 2
Suzhou Sanegene Bio Inc.·Not yet recruiting·Primary completion 1 July 2026·NCT06786338
NC
Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy
Phase 2
Nanjing Chia-tai Tianqing Pharmaceutical·Not yet recruiting·Primary completion 1 Sept 2026·NCT06982040
WB
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Phase 2
Walden Biosciences·Recruiting·Primary completion 1 Mar 2027·NCT06466135
KB
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
Phase 2
Keymed Biosciences Co.Ltd·Recruiting·Primary completion 30 June 2027·NCT05775042

Fc Fusion ProteinASX peers ›

8 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

V,
Atacicept in Subjects With IgA Nephropathy
Phase 3
Vera Therapeutics, Inc.·Active, not recruiting·Primary completion 15 May 2025·NCT04716231
TA
To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy
Phase 3
The Affiliated Hospital of Xuzhou Medical University·Active, not recruiting·Primary completion 25 May 2025·NCT07098897
RC
A Study of Telitacicept for IgA Nephropathy (TELIGAN)
Phase 3
RemeGen Co., Ltd.·Active, not recruiting

Antisense oligonucleotideASX peers ›

1 activeexpand ›

Class profileexpand ›

Description

Synthetic single-stranded oligonucleotides that bind a target mRNA by Watson-Crick base pairing, either triggering its degradation (RNase H recruitment) or altering its splicing (exon skipping/inclusion). The chemistry is off-the-shelf and small-batch; the principal limiter is not target identification but delivery, since systemic tissue uptake (especially CNS and skeletal muscle) is poor and most approved ASOs require intrathecal or local dosing. ATL1102 (Antisense Therapeutics / Percheron) is an antisense against CD49d (the VLA-4 integrin subunit), an anti-inflammatory target, rather than an exon-skipping dystrophin agent.

Class benchmarks

The class has a real regulatory track record. Approved ASOs include nusinersen (Spinraza, spinal muscular atrophy — a blockbuster), the Sarepta exon-skipping Duchenne series (eteplirsen, golodirsen, casimersen), inotersen, mipomersen and tofersen (ALS). It carries both genuine successes and high-profile efficacy debates: the Duchenne approvals were granted on a surrogate (dystrophin expression) under accelerated approval with confirmatory-trial obligations, and clinical-benefit confirmation has been contentious.

Commercial track record

Spinraza showed multi-billion-dollar potential for a rare-disease ASO before gene-therapy (Zolgensma) and oral competitors arrived. The commercial moat is moderate — sequence and composition-of-matter IP plus a manufacturing and regulatory learning curve — but newer modalities (siRNA, AAV gene therapy) increasingly contest the same rare-disease indications.

Capital intensity

Synthetic oligonucleotide manufacture is well-established and far cheaper than cell or gene therapy. The economic risk is not cost-of-goods but the narrow rare-disease patient pools and the chronic-dosing and delivery burden that shape pricing and adherence.

Regulatory posture

The FDA has repeatedly used accelerated approval on biomarker surrogates for ASOs in rare neuromuscular disease (the Duchenne exon-skippers, tofersen), lowering the evidentiary bar to first approval but attaching confirmatory-trial risk. For an anti-inflammatory ASO such as ATL1102 the path is less templated: the target is not a splicing correction, so the pivotal endpoint would likely need to be a functional clinical measure rather than a protein biomarker.

Class sources (4)

Spinraza (nusinersen) prescribing information · FDA · accessed 29 May 2026
Amondys 45 / Exondys 51 (casimersen, eteplirsen) prescribing information · FDA · accessed 29 May 2026
Percheron Therapeutics (formerly Antisense Therapeutics) — ATL1102 program · Percheron Therapeutics · accessed 29 May 2026
Crooke ST et al — Antisense technology: an overview and prospectus (Nat Rev Drug Discov 2021) · Nature Reviews Drug Discovery · accessed 29 May 2026

HR
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Phase 3
Hoffmann-La Roche·Recruiting·Primary completion 31 Aug 2026·NCT05797610