Competitive development · Focal segmental glomerulosclerosis
Column-per-asset comparison of the most advanced FSGS study for ten assets, anchored to ClinicalTrials.gov and cross-checked against current regulator labels. Sections run from target population and positioning, through study design and endpoints, to development context, current approved labels and forecast label expansion. Non-FSGS activity appears only in the “other active indications” and audience rows.
Forecast disclaimer. Rows and labels marked “Expected label indication (forecast)” are analyst assessments, not facts. They are not regulatory decisions, sponsor guidance, or statements of approval or exact wording. Only rows marked “current approved label” reflect granted indications as of 23 Jul 2026.
Counted by distinct trial anchor (8 total) to avoid triple-counting the shared RESULT umbrella. Toggle shows the alternative asset count (10).
By anchor (8): Phase 3 = 3 (ACTION3, BI 764198 recruiting; DUPLEX completed); Phase 2/2a = 5 (RESULT, PIONEER, praliciguat recruiting; AFFINITY active-not-recruiting; obinutuzumab completed). By asset (10), the three RESULT molecules are counted separately, giving 3 Phase 3 and 7 Phase 2/2a.
All ten assets fall into 6 broad families, but each asset is a distinct molecule-level class (10 total). Bars show assets per family; molecule detail is preserved in the legend and matrix.
Endothelin (2): sparsentan, atrasentan. B-cell/antibody (3): obinutuzumab, atacicept, rilzabrutinib. Costim/cytokine (2): frexalimab, brivekimig. Chemokine (1): DMX-200. NO–cGMP (1): praliciguat. Podocyte ion-channel (1): BI 764198.
Verified regulatory status as of 23 Jul 2026 — how many of the ten assets carry an approved label (any indication, any jurisdiction) versus remain investigational, and how many are approved specifically for FSGS.
5 of 10 assets are approved for at least one indication; 5 remain investigational. Only sparsentan (Filspari) holds an FSGS indication (US FDA, 13 Apr 2026) — the first and only approved FSGS medicine.
Study start (◆), primary completion (◇ open diamond) and study completion (●) for each of the eight distinct anchors, spanning 2018–2030. Solid bars run to the last Actual milestone; hatched bars mark Estimated future dates. RESULT covers frexalimab, brivekimig and rilzabrutinib. Scroll horizontally on small screens.
DUPLEX · NCT03493685
AFFINITY · NCT04573920
Investigator-led · NCT04983888
RESULT (umbrella) · NCT06500702
RESULT (umbrella) · NCT06500702
RESULT (umbrella) · NCT06500702
PIONEER · NCT06983028
ACTION3 · NCT05183646
Investigator/sponsor · NCT07268638
Sponsor trial · NCT07220083
| Attribute | Sparsentan (Filspari)Travere TherapeuticsEndothelin-pathway |
Atrasentan (Vanrafia)NovartisEndothelin-pathway |
ObinutuzumabGenentechB-cell / antibody |
FrexalimabSanofiCostim / cytokine |
BrivekimigSanofiCostim / cytokine |
Rilzabrutinib (Wayrilz)SanofiB-cell / antibody |
Atacicept (Trutakna)Vera TherapeuticsB-cell / antibody |
DMX-200DimerixChemokine-pathway |
PraliciguatAkebia TherapeuticsNO–cGMP |
BI 764198Boehringer IngelheimPodocyte ion-channel |
|---|---|---|---|---|---|---|---|---|---|---|
| Target population & positioning | ||||||||||
| Targeted FSGS populationWho the anchor trial enrols | Biopsy-proven primary or genetic FSGS. | Biopsy-proven / genetic FSGS cohort within a multi-disease Phase 2 basket. | Immunosuppression-dependent/-resistant primary FSGS; steroid-refusal/CI. | Biopsy primary FSGS or MCD; steroid-responsive history; APOL1 alleles eligible; collapsing excluded. | As RESULT: primary FSGS or MCD (shared umbrella). | As RESULT: primary FSGS or MCD (shared umbrella). | Primary nephrotic syndrome cohort: biopsy MCD/FSGS with anti-nephrin antibodies. | Primary, genetic, or undetermined-cause FSGS on background ARB; biopsy ≤7 yr. | Biopsy-confirmed FSGS (collapsing excluded). | Biopsy primary FSGS OR genetic FSGS from TRPC6 gain-of-function variant. |
| Proteinuria entry (UPCR) | UP/C ≥1.5 g/g | UPCR >1.0 g/g (FSGS cohort) | Nephrotic (>3.5 g/24h) pre-IST; foot-process effacement ≥80% | UPCR ≥3 g/g (or ≥1.5 g/g if eGFR ≥60) | UPCR ≥3 g/g (or ≥1.5 g/g if eGFR ≥60) | UPCR ≥3 g/g (or ≥1.5 g/g if eGFR ≥60) | FSGS/NS cohort UPCR ≥1.0 g/g | Urine PCR >1.5 g/g (or >1.5 g/day) | UPCR ≥1 g/g | UPCR ≥1500 mg/g (mean spot + FMV) |
| eGFR entry threshold | ≥30 mL/min/1.73m² | ≥30 mL/min/1.73m² | No explicit eGFR cut-off (nephrotic disease) | ≥45 mL/min/1.73m² | ≥45 mL/min/1.73m² | ≥45 mL/min/1.73m² | ≥30 mL/min/1.73m² (NS cohort) | ≥25 and ≤120 (adults); ≥25 (adolescents) | ≥25 mL/min/1.73m² | ≥25 (cystatin-C CKD-EPI adults; CKiD-U25 adolescents) |
| Mechanism / molecule class10 distinct classes; family in header | Dual endothelin (ETA) + angiotensin II (AT1) receptor antagonist (DEARA) | Selective endothelin type A (ETA) receptor antagonist | Anti-CD20 cytolytic monoclonal antibody (B-cell depletion) | Second-generation anti-CD40L mAb (non-depleting costimulation blockade) | Bispecific pentavalent Nanobody inhibiting TNF-α and OX40L | Reversible, covalent oral BTK inhibitor | Dual BAFF/APRIL inhibitor (recombinant TACI-Fc fusion) | CCR2 inhibitor (blocks CCR2/AT1R heteromer; anti-inflammatory) | Oral once-daily soluble guanylate cyclase (sGC) stimulator | Oral transient receptor potential channel C6 (TRPC6) inhibitor |
| Current approved label indicationsJurisdiction-specific; 23 Jul 2026 | Approved US FDA: IgAN + FSGS (≥8 yr, no nephrotic syndrome). EMA/UK: IgAN only. | Approved US FDA: IgAN (accelerated). EMA/UK: none. FSGS: not approved. | Approved US & EU: CLL, follicular lymphoma, lupus nephritis. No FSGS label anywhere. | No approved label Investigational (MS Phase 3 leading). | No approved label Investigational (HS Phase 2 lead). | Approved US FDA: ITP. EMA: IgG4-RD orphan designation only. No FSGS label. | Approved US FDA: IgAN (accelerated; Trutakna). EMA/UK: none. No FSGS label. | No approved label Investigational (FSGS lead; dev brand QYTOVRA). | No approved label Investigational. | No approved label Investigational. |
| Expected label indications (forecast)Analyst assessment — not fact, not sponsor guidance | Forecast · Med EU/UK FSGS likely to follow US; possible paediatric/label expansion. | Forecast · Low–Med Possible FSGS/broader proteinuric-GN label; EU IgAN likely. | Forecast · Low FSGS SLE expansion likely (Med); FSGS unlikely near-term. | Forecast · Low FSGS MS (RMS/nrSPMS) most likely first approval (Med). | Forecast · Low FSGS HS most likely first approval (Low–Med). | Forecast · Low FSGS wAIHA / IgG4-RD next (Med); FSGS early. | Forecast · Low FSGS LN, pMN, FSGS/MCD expansion possible; EU IgAN likely (Med). | Forecast · Med FSGS is the registrational target; pivotal Phase 3 completes 2029. | Forecast · Low FSGS then other podocytopathies. | Forecast · Med FSGS incl. TRPC6-genetic is registrational target. |
| Other active indicationsFSGS excluded | IgA nephropathy (approved); paediatric EPPIK basket historically. | IgAN (approved, ALIGN pivotal); DKD, Alport cohorts within AFFINITY. | CLL, follicular lymphoma, LN (approved); SLE (Phase 3 positive). | MS (Phase 3 FREXALT/FREVIVA/FREXCITE); SLE & type 1 diabetes (Phase 2). | Hidradenitis suppurativa (Phase 2, met primary); type 1 diabetes (OBTAIN). | ITP (approved); wAIHA (Phase 2/3 LUMINA 3); IgG4-RD (Phase 2). | IgAN (approved); pMN, IgAN/IgAVN in PIONEER; Phase 3 ORIGIN 3 confirmatory. | FSGS is lead; no other active FSGS-comparable indications. | Planned other rare podocytopathies. | FSGS only per this record. |
| Primary specialist audiencePrescribing/referring clinicians | Nephrology | Nephrology | Nephrology; haematology/oncology; rheumatology/immunology | Nephrology; neurology; endocrinology | Nephrology; dermatology; endocrinology | Nephrology; haematology; immunology/rheumatology | Nephrology | Nephrology | Nephrology | Nephrology |
| Study design | ||||||||||
| Most advanced FSGS trial | DUPLEX · Phase 3 NCT03493685 |
AFFINITY · Phase 2 NCT04573920 |
Phase 2 (no acronym) NCT04983888 |
RESULT · Phase 2a NCT06500702 |
RESULT · Phase 2a NCT06500702 |
RESULT · Phase 2a NCT06500702 |
PIONEER · Phase 2 NCT06983028 |
ACTION3 · Phase 3 NCT05183646 |
Phase 2 (no acronym) NCT07268638 |
Phase 3 (no acronym) NCT07220083 |
| Design / comparator | Randomized, double-blind, parallel; active comparator irbesartan. | Open-label, single-group, non-randomized basket; no comparator. | Open-label, single-group; no comparator. | Randomized, double-blind, placebo-controlled umbrella (multi-arm). | Randomized, double-blind, placebo-controlled umbrella (multi-arm). | Randomized, double-blind, placebo-controlled umbrella (multi-arm). | Open-label, single-group, non-randomized (multi-cohort). | Randomized, quadruple-blind, placebo-controlled + OLE. | Randomized, triple-blind, placebo-controlled; 24-wk DB + 24-wk OLE. | Randomized, quadruple-blind, parallel, placebo-controlled; 104-wk. |
| Age band | 8–75 yr | ≥18 yr | ≥18 yr | 16–75 yr | 16–75 yr | 16–75 yr | ≥2 yr (FSGS/NS cohort ≥10 yr) | 12–80 yr | ≥18 yr | ≥12 yr |
| Enrolment (target)A = Actual · E = Estimated | 371 A | 103 A (all cohorts) | 20 A | 84 E (shared) | 84 E (shared) | 84 E (shared) | 250 E (all cohorts) | 286 E | 60 E | 286 E |
| Background therapy | Non-immunosuppressive; RAAS washout (ARB active control) | Max-tolerated RASi (ACEi/ARB) stable ≥12 wk | Prior/failed rituximab, CNI, steroids allowed | ≤10 mg/day prednisone; stable RAASi/SGLT2i | ≤10 mg/day prednisone; stable RAASi/SGLT2i | ≤10 mg/day prednisone; stable RAASi/SGLT2i | Stable standard of care per disease | ARB at max tolerated dose (add-on design) | Max-tolerated ACEi or ARB | Non-immunosuppressive; excludes recent IV IS |
| Endpoints & evidence | ||||||||||
| Primary endpoint(s) | eGFR slope (Day1→Wk108); % FSGS partial remission (FPRE) at Wk36. | Δ proteinuria (FSGS cohorts, 0.75 & 1.5 mg). | Δ proteinuria (baseline, 12, 24 mo). | % UPCR reduction baseline→Wk12. | % UPCR reduction baseline→Wk12. | % UPCR reduction baseline→Wk12. | AE profile; % UPCR reduction baseline→Wk36. | UPCR at Wk35; eGFR slope to Wk104. | Δ UPCR baseline→Wk24. | Relative Δ 24-h UPCR baseline→Wk104. |
| Key secondary endpoints | Modified/chronic eGFR slope; eGFR change 4 wk post-cessation. | Δ albuminuria (DKD); proteinuria across cohorts; safety. | Remission at 12 mo; Δ serum albumin; SAEs; proteinuria 18 & 24 mo. | % partial/complete remission; TEAEs/SAEs; PK; ADAs. | % partial/complete remission; TEAEs/SAEs; PK; ADAs. | % partial/complete remission; TEAEs/SAEs; PK; ADAs. | Δ eGFR; Δ disease-specific antibodies. | AEs; kidney-function/proteinuria params; OLE long-term safety/efficacy. | % partial remission at Wk24; praliciguat PK. | Δ eGFRcys; UPCR<1000 mg/g response; complete remission UPCR<300; COA/KDQOL-36. |
| Interpretation note | Pivotal, active-controlled with long eGFR slope; broad age/genetic scope affects PICO comparability. | Single-arm FSGS cohort within a multi-disease basket; clean FSGS read-across needs care. | Small, single-arm, refractory-population signal-finding study; low N. | Placebo-controlled but short primary (12 wk); molecule-specific inference despite shared platform. | Placebo-controlled but short primary (12 wk); molecule-specific inference despite shared platform. | Placebo-controlled but short primary (12 wk); molecule-specific inference despite shared platform. | Open-label, mixed-disease basket; FSGS/MCD cohort must be isolated for comparison. | Large pivotal add-on to ARB; long eGFR-slope follow-up strengthens value case. | Small proof-of-concept; collapsing FSGS excluded narrows population. | Long 104-wk primary with hard remission thresholds; adolescent inclusion aids paediatric relevance. |
| Development context | ||||||||||
| Development maturity | Phase 3 Completed | Phase 2 Active, not recruiting | Phase 2 Completed | Phase 2a Recruiting | Phase 2a Recruiting | Phase 2a Recruiting | Phase 2 Recruiting | Phase 3 Recruiting | Phase 2 Recruiting | Phase 3 Recruiting |
| Key timelineStart · primary completion · study completion | Start Apr 2018 A · primary Mar 2023 A · complete Mar 2026 A | Start Mar 2021 A · primary Jul 2024 A · complete Oct 2026 E | Start Nov 2021 A · primary & complete Jun 2025 A | Start Dec 2024 A · primary Dec 2026 E · complete Feb 2028 E | Start Dec 2024 A · primary Dec 2026 E · complete Feb 2028 E | Start Dec 2024 A · primary Dec 2026 E · complete Feb 2028 E | Start Jul 2025 A · primary & complete Nov 2027 E | Start May 2022 A · primary & complete Dec 2029 E | Start Dec 2025 A · primary Jun 2027 E · complete Jan 2028 E | Start Feb 2026 A · primary Dec 2028 E · complete Jan 2029 E |
| HTA / evidence caveat | Active-control (ARB) and mixed paediatric/genetic scope complicate a placebo-referenced PICO. | Basket single-arm design limits comparative-efficacy evidence for FSGS-specific HTA. | Very small, uncontrolled, refractory-only; hypothesis-generating for reimbursement. | Short primary window and shared platform require molecule-level effect isolation. | Short primary window and shared platform require molecule-level effect isolation. | Short primary window and shared platform require molecule-level effect isolation. | Open-label mixed-disease design weakens comparative certainty for FSGS PICO. | Add-on-to-ARB positioning defines a specific comparator; long slope data support value. | Small POC; exclusion of collapsing FSGS narrows generalisability. | Placebo comparator and hard remission endpoints align well with HTA needs; adolescents add scope. |
| Sources | ||||||||||
| Primary registry source | CT.gov NCT03493685 (DUPLEX) | CT.gov NCT04573920 (AFFINITY) | CT.gov NCT04983888 | CT.gov NCT06500702 (RESULT) | CT.gov NCT06500702 (RESULT) | CT.gov NCT06500702 (RESULT) | CT.gov NCT06983028 (PIONEER) | CT.gov NCT05183646 (ACTION3) | CT.gov NCT07268638 | CT.gov NCT07220083 |
| Label / regulatory source | FDA label 216403s006EMA Filspari EPAR | FDA Vanrafia snapshotFDA label 219208 | FDA Gazyva labelEMA Gazyvaro EPAR | Sanofi MS pipeline PR | Sanofi HS/MOA PR | FDA Wayrilz approval | Vera FDA Trutakna approval | Dimerix ACTION3 poster | Akebia first-patient PR | CT.gov official title (MOA) |
| Forecast rationale sourceBasis for analyst assessment | Travere FSGS approval PR | AFFINITY registry (Ph2 basket) | SLE Phase 3 result | Frexalimab MS Phase 3 data | Brivekimig HS Phase 2 | Rilzabrutinib wAIHA LUMINA 3 | PIONEER FSGS cohort (Ph2) | ACTION3 pivotal Phase 3 | Prior DKD Phase 2 (missed) | Phase 3 pivotal registry |
An executive-ready framework to keep the ten assets and eight anchors accurate over time — objective, data model, source hierarchy, refresh cadence, alert triggers, governance, and a worked example of recent changes.
Populated from this fact-check cycle. Each row links to the evidence that drove the change. Scroll horizontally on small screens.
| Asset | Change summary | Field | Severity | Source type | Last checked | Owner | Evidence |
|---|---|---|---|---|---|---|---|
| Sparsentan (Filspari) | Full FDA approval for FSGS added (13 Apr 2026); previously IgAN-only. | Approved label | High | Regulator label | 23 Jul 2026 | Analyst A | FDA label ↗ |
| Atacicept (Trutakna) | FDA accelerated approval for IgAN (7 Jul 2026); brand Trutakna (atacicept-vymj) added — no longer purely investigational. | Approved label / brand | High | Sponsor / regulator | 23 Jul 2026 | Analyst B | Vera IR ↗ |
| RESULT (Sanofi ×3) | Umbrella relabelled Phase 2a; dates re-flagged (start Dec 2024 Actual; primary Dec 2026 & completion Feb 2028 Estimated); registry last-update 20 Jul 2026. | Phase / dates | Medium | Registry (CT.gov) | 23 Jul 2026 | Analyst A | CT.gov RESULT ↗ |
| Atacicept (Trutakna) | FSGS anchor trial name corrected to PIONEER (previously unnamed); confirmed multi-glomerular-disease study incl. FSGS/MCD anti-nephrin cohort. | Trial name / scope | Low | Registry (CT.gov) | 23 Jul 2026 | Analyst B | CT.gov PIONEER ↗ |
| Brivekimig | Mechanism corrected from "anti-IL-13" to TNF-α / OX40L bispecific Nanobody; mechanism-class count raised to 10. | Mechanism | Medium | Sponsor / literature | 23 Jul 2026 | Analyst A | Sanofi PR ↗ |