IgA Nephropathy Clinical Trial Landscape
IgA nephropathy is the most common primary glomerulonephritis worldwide, driven by deposition of galactose-deficient IgA1 immune complexes that inflame the glomerulus and, in a substantial fraction of patients, progress to kidney failure over time. For decades it was managed empirically with supportive RAAS blockade and blood-pressure control, with broad systemic immunosuppression reserved for higher-risk disease despite an uncertain benefit-risk balance.
That changed as the field embraced disease-specific mechanisms targeting the underlying immunology and hemodynamics rather than generic immune suppression. The result is a newly activated, fast-moving treatment landscape with multiple distinct mechanisms now carrying approved agents.
Trial activity
Competitive Intelligence
This IgA Nephropathy competitive landscape maps 21 companies against 7 mechanisms of action (MOA) across 23 active drug-development programs, including 1 with a confirmed FDA PDUFA date. Each cell is the lead program for a company–mechanism pair — its trial phase, modality, combination, and nearest readout. Read down a column to see who is competing on the same mechanism in IgA Nephropathy, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.
IgA nephropathy has moved fast from one approved drug to a real treatment menu, with an endothelin antagonist, a targeted-release steroid, and the first APRIL/BAFF and complement agents now on the market. The contest now centers on BAFF/APRIL biology and complement inhibition, where Novartis brings the broadest pipeline but smaller players like RemeGen and Vera carry the assets closest to readout. Newer entrants are pushing past those validated targets into less-trodden biology, a sign the field is shifting from proving the category works to differentiating on mechanism and durability.
- 57 assets tracked across 20 companies; 44 have a defined mechanism.
- BAFF/APRIL inhibitors lead with 16 assets, ahead of Complement Factor B/D (9), endothelin receptor antagonists (6), and anti-CD38 mAbs (3).
- Novartis (9 assets) and Vera (4) together account for 70% of the named pipeline; 4 assets are new molecular entities.
- Most novel emerging mechanism: Keymed's MASP-2 inhibitor (Phase 2); 4 assets sit in the long tail.
Forward catalysts next 18 months⏰ 6 due ≤6 mo⚖ 1 PDUFA-dated
primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.Company × Mechanism
BAFF/APRIL inhibitor | Complement Factor B/D inhibitor | Endothelin receptor antagonist | Anti-CD38 (mAb) | Complement C5 inhibitor | AT1R / ETA antagonist | Complement C3 inhibitor | |
|---|---|---|---|---|---|---|---|
| Novartis | |||||||
| Vera | |||||||
| 🇨🇳Chengdu Suncadia Medicine | |||||||
| Otsuka Pharmaceutical Develop… | |||||||
| Alpine Immune Sciences (Verte… | |||||||
| AstraZeneca | |||||||
| Biocity Biopharmaceutics | |||||||
| Haisco Pharmaceutical Group | |||||||
| 🇨🇳Hansoh BioMedical R&D Company | |||||||
| 🇨🇳Rigerna Therapeutics Co., Ltd… | |||||||
| Keymed | |||||||
| ADARx | |||||||
| 🇨🇳Beijing Mabworks | |||||||
| Biogen | |||||||
| Chinook | |||||||
| Climb Bio | |||||||
| 🇨🇳Nanjing Chia-tai Tianqing | |||||||
| 🇨🇳RemeGen | |||||||
| 🇨🇳Sinocelltech | |||||||
| Travere | |||||||
| 🇨🇳Wuhan Createrna Science and T… |
Phase 3 leaders · most advanced
- recruiting Hoffmann-La Roche NCT05797610
- recruiting Novartis Pharmaceuticals NCT06858319
- recruiting Biogen NCT06935357
- active Novartis Pharmaceuticals NCT04557462
- active Travere Therapeutics, Inc. NCT03762850
Beyond the grid Beta
Single-company mechanisms — BD white space 3 found
Single-program mechanisms (5) — one program each — earliest-stage, sorted by phase
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph3 | FACTOR B ⚡ 🌱 🆕 | Novartis | 4Q30 | NCT04557462 | |
| Ph3 | FcγRIIb 🌱 🆕 | Takeda | 3Q28 | NCT06963827 | |
| Ph2 | Complement C5 / Factor H inhibitor 🌱 🆕 | Kira Pharmacenticals (US)… | 1Q26 | NCT05517980 | |
| Ph2 | MASP-2 inhibitor ⚡ 🌱 🆕 | Keymed | 2Q27 | NCT05775042 | |
| Ph1 | Gd-IgA1 degrader ⚡ 🌱 🆕 | Pfizer | 3Q27 | NCT07054684 |
Unclassified programs (12) — mechanism not captured yet
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Ph3 | Sefaxersen (RO7434656), Placebounclassified | Hoffmann-La Roche | NCT05797610 | ||
| Ph2 | JADE101unclassified | Jade Biosciences, Inc. | NCT07541287 | ||
| Ph2 | EVER001unclassified | Everest Medicines (China)… | NCT07614477 | ||
| Ph2 | SHR-2173 injection, SHR-2173 injection, SHR-2173 injectionunclassified | Guangdong Hengrui Pharmac… | NCT07354932 | ||
| Ph2 | SLN12140unclassified | Linno Pharmaceuticals, In… | NCT07553494 | ||
| Ph2 | ADX-038 Dose Level 2, ADX-038 Dose Level 1unclassified | ADARx Pharmaceuticals, In… | NCT06989359 | ||
| Ph2 | NM8074unclassified | NovelMed Therapeutics | NCT06454110 | ||
| Ph2 | WAL0921, Placebounclassified | Walden Biosciences | NCT06466135 | ||
| Ph2 | FXS6837 Dose 1, FXS6837 Dose 2, Placebo Capsuleunclassified | Shanghai Fosun Pharmaceut… | NCT07502638 | ||
| Ph1+Ph2 | PS-002 for the Treatment of IgA Nephropathy in Adultsunclassified | Purespring Therapeutics L… | NCT07182227 | ||
| Ph2 | HS-10542 High Dose, HS-10542 Low Dose, Placebounclassified | Jiangsu Hansoh Pharmaceut… | NCT07474636 | ||
| Ph2 | SGB-9768unclassified | Suzhou Sanegene Bio Inc. | NCT06786338 |
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
How the field has grown
New-trial starts peaked in 2025 (24 registered). The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (33 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.
New trials started by year
TheraRadar.com
Median Phase 3 enrollment by start year
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
Frequently asked
Common questions about the IgA Nephropathy landscape
- How many companies are developing IgA Nephropathy treatments?
- 21 companies have active or registered IgA Nephropathy programs in TheraRadar's competitive landscape (46 classified trials). The most active are Novartis, Vera, and Chengdu Suncadia Medicine.
- What mechanisms of action are being developed for IgA Nephropathy?
- 7 distinct mechanisms of action appear across the IgA Nephropathy pipeline, including BAFF/APRIL inhibitor, Complement Factor B/D inhibitor, Endothelin receptor antagonist, Anti-CD38 (mAb), and Complement C5 inhibitor.
- What is the most crowded mechanism in IgA Nephropathy?
- BAFF/APRIL inhibitor is the most contested mechanism in IgA Nephropathy, with 17 programs mapped to it.
- Are there upcoming IgA Nephropathy clinical readouts or FDA decisions?
- Near-term IgA Nephropathy catalysts include Telitacicept (data readout, Jun '26); MY008211A tablets (data readout, Jun '26); CLYM116 (data readout, Jul '26). Dates combine estimated trial primary-completion readouts and confirmed FDA decision dates.
- Where does TheraRadar's IgA Nephropathy landscape data come from?
- Programs are derived from industry-sponsored ClinicalTrials.gov registrations (2008–present) and classified by mechanism of action using a curated rule set plus an LLM pipeline. Every cell links to its underlying trials, so each program is verifiable.
- Is the IgA Nephropathy heatmap free to use?
- Yes — viewing and searching the IgA Nephropathy heatmap is free. A TheraRadar Pro subscription adds advanced filters, row/column selection, and one-click export to PowerPoint, PDF, and CSV.
How this is built — methodology & limits
These grids are only as good as the data and the classification behind them — so here is exactly what goes in, what stays out, how every assignment is made, and where the limits are.
Where the data comes from
Every heatmap is built from the public ClinicalTrials.gov registry, via its official API — interventional drug and biologic trials with a start date of 2008 or later. The master index holds over 145,000 trials and is refreshed weekly (see the “updated” date on this page). A disease landscape draws only from the active, Phase 1–3, industry-sponsored slice of that index.
- In scope: industry-sponsored trials in Phase 1, 2, or 3, with an active status (recruiting, active-not-recruiting, not-yet-recruiting, or enrolling by invitation). Phase 4 sits in the index but is left out of the landscapes.
- Filtered out: deeply stale programs (a primary completion date more than two years past with no update to completed or terminated); basket trials and incidental mentions (a trial counts toward a disease only when that disease is genuinely the subject of study — not a secondary cohort, an organ-of-origin overlap, or a passing mention); and healthy-volunteer studies.
We do not exclude trials by sponsor geography. Where a sponsor is based in China, the program is flagged on the page rather than hidden, so you can weigh it yourself. An automated test fails the weekly refresh if the underlying index is more than 14 days old, so a published grid is never built on a stale index.
How a trial is matched to a disease
Matching uses a structured medical ontology, not keyword guessing, and is designed so that no trial is ever silently dropped — every trial that clears the filters gets a classification, even if that is just “Other.” It runs as an ordered sequence of steps, stopping at the first that applies:
- Healthy-volunteer studies are set aside as non-disease trials.
- Ontology match — each tracked disease is linked to its official identifiers in the standard medical taxonomy (MeSH), so a trial can be matched even when its text uses a synonym.
- Curated disease patterns — a hand-maintained library of over 150 disease-name patterns covers the more granular indications across oncology, hematology, infectious disease, cardiometabolic, immunology, and neuropsychiatry.
- Basket guard — a trial matching four or more distinct diseases, or carrying explicit basket language (“tumor-agnostic,” “all solid tumors,” “pan-cancer”), is grouped into a single advanced-solid-tumor category rather than over-counted across every cancer it touches.
- Therapeutic-area roll-up — a trial with no specific match, but which the taxonomy still places under a broad area, is assigned to that area (“Oncology — other,” “Immunology — other,” …), checking cancers first so a site-specific tumor isn’t filed under its anatomical system.
A “drop-if-parent-present” rule keeps a generic name from drowning out a subtype: a trial matching both lupus and lupus nephritis is reported only as lupus nephritis. Internal abbreviations are translated to the plain disease names used across the site (for example, “CRC” becomes “Colorectal Cancer”), and the same classifier is shared by every heatmap, so the same trial always maps to the same disease wherever it appears.
How a drug is matched to its mechanism
Mechanism of action is the hardest part to get right, so it is assigned in layers — leaning on curated and public data first, with AI as a last resort:
- Curated rulebook (first). A rulebook we maintain — over 600 drug-to-mechanism rules — is checked first, matching on drug names, trial acronyms, sponsor trial identifiers, and intervention lists. First match wins, which stops a combination trial from being counted several times.
- Public molecular-target data. Where no rule applies, each intervention’s target is looked up in a public target database, with verbose or gene-symbol labels normalized into consistent short forms so one target isn’t split across several columns.
- Standard-of-care backbones. A small set of rules recognizes common combination scaffolds (checkpoint-inhibitor monotherapy, standard chemotherapy regimens, established standard-of-care agents) so they aren’t mistaken for the experimental arm.
- AI as a last resort, then cross-checked. Only for genuinely opaque sponsor code-names that none of the first three steps can resolve do we ask an AI model to propose a mechanism — applied only above a fixed confidence bar, then automatically cross-checked against the sponsor’s own pipeline page. Where AI and the sponsor agree, the program is marked sponsor-verified. Where they contradict, the label is discarded entirely — not shown, not counted.
New mechanism rules are independently double-verified before they’re trusted — a second, adversarial pass set up to disprove the first — and each is checked so it can’t mislabel an unrelated trial. Drugs whose mechanism isn’t publicly disclosed are shown openly as “Emerging — not yet disclosed” rather than guessed at: for a tool meant to support real decisions, “we don’t yet know” is a more trustworthy answer than a confident guess.
Where AI is used — and where it isn’t
The disease and mechanism matching above is driven first by deterministic rules and public ontologies, not AI. AI plays three bounded, disclosed roles: (1) an optional extra check that a trial genuinely studies the disease, on top of the ontology match; (2) inferring a trial’s treatment setting on the competitive grids when the rules don’t cover it, only above a fixed confidence bar; and (3) the last-resort mechanism step above, always cross-checked against the sponsor’s disclosures. Wherever an AI label reaches a cell, the page marks it (⚙️ or ✅) — AI is never the silent, sole source of what you see.
What the on-page markers mean
- ✅ Sponsor-verified — AI proposed the mechanism and it matched the sponsor’s own pipeline page. High-trust.
- ⚙️ AI-classified — AI proposed it above the confidence bar but it has not yet been cross-checked against the sponsor. Useful; verify before citing. It never means a person reviewed it.
- ⚡ First-in-class — the mechanism hasn’t appeared in any other disease landscape we’ve built. This reflects the scope of landscapes published so far (the tooltip lists exactly which were scanned), not an absolute claim about the whole market.
- 🌱 First-in-indication — the only program competing on that mechanism within this disease.
- 🆕 NME candidate — the interventions match no drug in our approved-drug index, suggesting a new molecular entity. The index is incomplete — a signal, not a regulatory fact.
- 🔗 Combination · 👶 Pediatric · 🔥 Hot (readout within six months) · ⏳ Stale (completion date passed but still marked active — often a stalled program).
Sponsor names are resolved through a curated parent/subsidiary map; unrecognized sponsors appear under their raw registry name. The registry records the sponsor at a trial’s inception, so names are as originally filed and may not reflect later acquisitions. To keep large grids legible, mechanisms with a single program are listed separately rather than crowding the main grid, and very small players are listed below it — presentation choices only; nothing is removed from the underlying counts.
How we score programs — “what’s about to move”
Each program carries a 0–100 score that deliberately ranks imminence over raw stage — the most decision-relevant signal on a competitive grid. It is the sum of:
- Clinical phase — up to 40 points (Phase 3 = 40, Phase 2 = 25, Phase 1 = 10).
- Readout proximity — up to 60 points (next readout <6 months = 60, 6–12 months = 45, 1–2 years = 30, distant = 5).
- Stale penalty — the score is halved if a trial is past its expected readout but still listed as active.
Cell colour on the grid is driven by this score, so a Phase 2 program about to read out can — correctly — outrank a dormant Phase 3 one. It answers “what’s about to move,” not just “what’s furthest along.”
What each grid plots
- Indication landscape (this page) — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
- Company portfolio — one company — diseases (rows) × mechanism (columns): where it is active, and what it is betting on.
- MOA platform — one mechanism family — drugs (rows) × diseases (columns): who is working on this class, and where.
- Competitive landscape — one disease — mechanism (rows) × clinical setting (columns), aggregated across companies; setting columns are tailored per disease (e.g. lines of therapy in oncology; biologic-naïve vs. biologic-experienced in IBD).
What we don’t claim
- First-in-class is editorial, not absolute — “not seen in the landscapes we’ve built,” not “novel across the industry.”
- NME candidate is a signal, not a filing — absent from our (incomplete) approved-drug index.
- Disease matching is automated and not exhaustively validated per disease — ontology and pattern matching can occasionally include or miss a trial.
- AI-classified mechanisms are machine-proposed — unconfirmed unless they also carry ✅.
- Sponsor names are as-filed and may lag current ownership.
- Grids are as fresh as their last rebuild from the weekly index — no faster continuous refresh is claimed.
Data: ClinicalTrials.gov v2 API + FDA Drugs@FDA (approved-drug index). Spot an error? [email protected].
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only