Fibrosis Drug Market 2026: IPF, MASH, CKD Forecasts

Introduction

The fibrosis drug landscape underwent a structural inflection in 2025-2026 across both approvals and mega-deals. MASH (formerly NASH) saw $8B+ in M&A activity, IPF broke a decade-long silence with a new approval, and CKD welcomed the first disease-modifying therapy for FSGS — across every fibrotic disease, "unmet medical need" was redefined as "investable market opportunity." This article synthesizes the global fibrosis drug market by disease segment, major deals, pipeline opportunities, and regional dynamics, based on publicly available information as of May 2026.

Quick Answer: The global Fibrotic Diseases Treatment market reached USD 5.79B (2024) and is projected to grow to USD 10.35B by 2032 per Data Bridge (CAGR 7.6%)¹. Disease-specific market estimates with explicit source and scope: IPF treatment market USD 3.68B (2024) → USD 5.46B (2030) per Grand View Research (CAGR 6.8%)³; global MASH/NASH treatment market USD 7.87B (2024) → USD 31.76B (2033) per DataM Intelligence (CAGR ~17.5%; F2-F3 segment USD 3.24B → 19.39B)⁴; CKD drugs market USD 30.87B (2025) → USD 67.81B (2034) per Fortune Business Insights (CAGR 9.17%)⁵. Definitions and scopes differ across firms; treat the figures as a paired (source, scope) tuple rather than a point estimate. 2025 MASH M&A totaled $8B+ (GSK/Roche/Novo Nordisk), redefining the field's gravitational center around FGF21 analogs.

[!TIP] Disease-specific deep dives: MASH Drug Landscape 2025 ／ MASH Combination Therapy Strategies 2026 ／ IPF Pipeline 2025-2026 ／ CKD Antifibrotic Landscape 2026

1. Global Fibrosis Treatment Market Size

Market size estimates vary significantly across research firms based on scope and methodology. We organize the data into three definitions:

Definition A: Fibrotic Diseases Treatment (Broad)

Encompasses all fibrotic indications (IPF, MASH, SSc, cardiac fibrosis, renal fibrosis, dermal fibrosis, etc.). Per Data Bridge Market Research:

• 2024 actual: USD 5.79 Billion
• 2032 forecast: USD 10.35 Billion
• CAGR: 7.6% (2025-2032)¹

Definition B: Antifibrotic Drug Market (Narrow)

Limited to drugs with direct antifibrotic mechanisms (pirfenidone, nintedanib, resmetirom, PDE4B/LPA1/integrin inhibitors). Multiple research firms publish independent estimates using divergent definitions — no single authoritative number exists.

• Order-of-magnitude: USD 3-4 Billion range (varies by source definition, geography, and reference year)²
• CAGR: 7-9.2% range
• Boehringer Ingelheim (nintedanib/Ofev) and Roche (pirfenidone/Esbriet) hold a combined market share of over 60%
• Note: as of 2026-05-24, the 360iResearch Antifibrotic Drug Market public page does not surface explicit figures; the values above are aggregated cross-source estimates, and rigorous citation requires the full report

Definition C: Disease-Specific Segments with Explicit Sources (2025-2026)

Disease	Market Size	CAGR	Source	Key Approved Drugs
IPF treatment market	USD 3.68B (2024) → USD 5.46B (2030)	6.8%	Grand View Research3	Pirfenidone, Nintedanib, Nerandomilast (Oct 2025 new)
Global MASH/NASH treatment market	USD 7.87B (2024) → USD 31.76B (2033)	~17.5%	DataM Intelligence4	Resmetirom (Mar 2024, accelerated), Wegovy (Aug 2025, accelerated)
MASH F2-F3 segment (treatment-eligible stages only)	USD 3.24B (2024) → USD 19.39B (2032)	27.2%	DataM Intelligence4	Same as above
CKD drugs market (broad, not antifibrotic-specific)	USD 30.87B (2025) → USD 67.81B (2034)	9.17%	Fortune Business Insights5	Finerenone, SGLT2i, Sparsentan (FSGS Apr 2026), Atrasentan (IgAN Apr 2025)
SSc-ILD / Systemic Sclerosis	(no carve-out published) — Tocilizumab, Nintedanib (SSc-ILD); niche	—	—	Nintedanib (SSc-ILD), Tocilizumab

Note: Market sizes vary widely depending on the research firm's scope (disease range, drug class, geography, forecast methodology). The CKD figure above is the "CKD drugs market" (broad, not limited to antifibrotic agents); MASH/NASH is the global treatment market per DataM Intelligence; IPF is the Grand View Research treatment-market scope. Carve-outs focused on antifibrotic-only or country-specific sub-segments require separate sources.

2. Five Most Important Fibrosis News Items 2025-2026 (Pre-Listed)

Per editorial discipline for year-tagged landscape articles, we pre-fix the five most important developments from 2025-2026 before drafting the body. Every section below references at least one of these:

1. [FDA Approval] Sparsentan (Filspari) FSGS Indication — Approved April 13, 2026 (Travere Therapeutics). The first-ever disease-modifying therapy in FSGS⁶
2. [FDA Approval] Nerandomilast (Jascayd) IPF/PPF — IPF approved October 7, 2025 (Boehringer Ingelheim); PPF added December 22, 2025. First new IPF treatment in over a decade⁷
3. [M&A] Novo Nordisk → Akero Therapeutics — October 2025, $4.7B + $0.5B approval milestone. Acquired efruxifermin (FGF21 analog)⁸
4. [Phase 3 Readout] Iptacopan APPLAUSE-IgAN Final — NEJM online March 29, 2026 + simultaneous WCN 2026 late-breaking presentation (Barratt J, PMID 41910396; 49.3% eGFR slowing, kidney function decline reduction at 24 months, composite kidney failure endpoint HR 0.57, Novartis). As of May 2026 the US label still lists IgAN under accelerated approval (proteinuria basis), with traditional approval submitted to FDA and priority review granted⁹
5. [Discontinuation] Pliant Therapeutics Bexotegrast — Full program halted June 27, 2025. αvβ6 integrin antagonist; treatment arm showed increased disease progression, respiratory hospitalization, and mortality risk¹⁰

3. MASH: $8B+ Mega-Deals Redefined the FGF21 Era

The 2025 MASH space was reshaped by three Big Pharma mega-acquisitions. See MASH Drug Landscape 2025 for full detail.

Acquirer	Target	Lead Asset	Upfront	Milestones	Date
GSK	Boston Pharmaceuticals	efimosfermin alfa (FGF21 analog)	$1.2B	up to $0.8B	May 202511
Roche	89bio	pegozafermin (FGF21 analog)	$2.4B	up to $1.1B	Sep 202512
Novo Nordisk	Akero Therapeutics	efruxifermin (FGF21 analog)	$4.7B	up to $0.5B (FDA approval)	Oct 20258

All three concentrated on FGF21 analogs — the 2025 transactions suggest strong Big Pharma conviction that FGF21 analogs offer a differentiated MASH mechanism delivering hepatic lipid metabolism, antifibrotic, and anti-inflammatory effects simultaneously. (Public statements on cross-company decision rationale remain limited, so this is presented as inferred conviction rather than confirmed strategy.)

Approved drug landscape:

• Resmetirom (Rezdiffra, Madrigal): FDA accelerated approval March 14, 2024 (conversion to traditional approval pending 54-month MAESTRO-NASH outcomes); EU conditional marketing authorization August 2025. Madrigal reported FY2025 net sales of ~US$958.4M (Q4 US$321.1M) as the company-disclosed figure¹³. Separately, analyst consensus forecasts $1.245B (2026), $2.564B (2027), and peak annual sales of $3.4-3.5B — these are analyst projections, not company guidance, and should be cited as such
• Wegovy (semaglutide, Novo Nordisk): FDA expanded indication for non-cirrhotic MASH with moderate-to-advanced fibrosis (August 2025)¹⁴
• Gilead Sciences: Discontinued the cilofexor + firsocostat + semaglutide MASH combination program with Novo Nordisk (August 2025)¹⁵. Claims about Gilead's company-wide fibrotic disease pipeline status should be checked against the current corporate pipeline disclosure; this article documents only the referenced MASH combination program halt

Combination strategies: GLP-1 + FGF21 and THR-β + FGF21 Phase 2/3 combination trials will define the MASH competitive landscape from 2027 onwards. See MASH Combination Therapy Strategies 2026.

4. IPF/PPF: Nerandomilast Approval and a Three-Way Pipeline Race

A decade of silence following the 2014 approvals of pirfenidone and nintedanib ended in 2025. See IPF Pipeline 2025-2026 for full analysis.

2025-2026 Key Movements

• Nerandomilast (Jascayd, Boehringer Ingelheim): Oral preferential PDE4B inhibitor. FIBRONEER-IPF (NCT05321069, n=1,177) showed +68.8 mL adjusted FVC vs placebo at week 52 (p<0.001)¹⁶. FDA IPF approval October 7, 2025⁷; PPF indication added December 22, 2025; China NMPA PPF approval December 10, 2025. EU/UK/PMDA filing and approval trajectory is the next checkpoint (no firm public approval-date commitment as of May 2026)
• Tyvaso (inhaled treprostinil, United Therapeutics): TETON-2 (n=597) met primary endpoint (+95.6 mL absolute FVC vs placebo at week 52; NEJM March 11, 2026)¹⁷. TETON-1 (n=598) also met primary endpoint (announced March 30, 2026: +130.1 mL FVC vs placebo, 95% CI 82.2-178.1 mL, p<0.0001), exceeding TETON-2 effect²⁸. Integrated TETON-1+TETON-2 analysis (+111.8 mL FVC, 95% CI 79.7-144.0 mL, p<0.0001) presented at ATS 2026 (May 18, Mini-Symposium B95). Combined sNDA filing planned by end of summer 2026
• BMS-986278 (Admilparant, Bristol Myers Squibb): Oral LPA1 antagonist. Phase 2 60mg BID slowed FVC decline in IPF (26 weeks) and PPF¹⁸. ALOFT-IPF (NCT06003426) completion expected October 2026
• Bexotegrast (Pliant Therapeutics): Oral αvβ6/αvβ1 integrin antagonist. BEACON-IPF Phase 2b/3 halted March 2025 (DSMB recommendation); full program discontinued June 2025 after analysis confirmed increased disease progression, hospitalization, and mortality risk in the treatment arm¹⁰

5. CKD/Renal Fibrosis: Three Concurrent Waves

The broad CKD drugs market is large — per Fortune Business Insights, USD 30.87B (2025) → USD 67.81B (2034), CAGR 9.17%⁵ — but that scope is "all CKD drugs," not antifibrotic-only. Fibrosis-focused drug development opportunities concentrate in three disease-specific waves. See CKD Antifibrotic Landscape 2026.

Wave 1: IgA Nephropathy

• Atrasentan (Vanrafia, Novartis): Selective ETA antagonist. FDA accelerated approval April 2025. ALIGN Week 136 final results (announced February 2026): eGFR difference +2.39 ml/min/1.73m² (p=0.057, marginally significant)¹⁹. Traditional approval filing planned within 2026
• Iptacopan (Fabhalta, Novartis): Complement factor B inhibitor. APPLAUSE-IgAN final (NEJM online March 29, 2026 + WCN 2026 late-breaking, Barratt J, PMID 41910396) achieved 49.3% eGFR slowing (kidney function decline reduction, 24-month endpoint; composite kidney failure endpoint HR 0.57)⁹. The earlier 9-month interim achieved 38.3% UPCR (proteinuria) reduction — note these are distinct endpoints (proteinuria at month 9 vs eGFR slope at 24 months), not the same metric improving over time. The two-step demonstration (proteinuria → eGFR preservation) is the clinically decisive package. As of May 2026 the US label still lists IgAN under accelerated approval (proteinuria basis); Novartis has filed for traditional approval with priority review granted. In Japan, Fabhalta obtained a C3G label expansion on May 19, 2025

Wave 2: FSGS

• Sparsentan (Filspari, Travere Therapeutics): ETAR/AT1R dual antagonist. FDA full approval April 13, 2026 (PDUFA date originally January 13, 2026, extended)⁶. First-ever disease-modifying therapy in FSGS. See Sparsentan FSGS Approval Significance
• Apecotrep (BI 764198, TRPC6 inhibitor, Boehringer Ingelheim): Phase 3 (NCT07220083, n=286, completion late 2029). Follow-on candidate to Sparsentan

Wave 3: APOL1-Mediated Kidney Disease

• Inaxaplin (VX-147, Vertex): APOL1 channel inhibitor. AMPLITUDE is a Phase 2/3 adaptive trial (NCT05312879); the Phase 3 portion's interim-analysis cohort completed enrollment on September 25, 2025. Interim analysis after 48 weeks of treatment (~September 2026), with potential for accelerated approval filing²⁰

Foundational Standard-of-Care

• Finerenone (Kerendia, Bayer): Non-steroidal mineralocorticoid receptor antagonist. FIDELIO/FIGARO/FIDELITY trials demonstrated renal and cardiovascular outcome benefits²¹. FINE-ONE testing expansion to non-diabetic CKD
• SGLT2 inhibitors (empagliflozin/Jardiance, dapagliflozin): EMPA-KIDNEY and DAPA-CKD established broad CKD coverage as the anchor therapy⁵

6. Key Players Map (2025-2026 Fibrosis Landscape)

Legend: 🟢 Approved drugs in portfolio ／ 🔵 Major M&A ／ 🟠 Seeking partner ／ 🔴 Discontinued / Exited

7. Pipeline Opportunities and Unmet Needs

Clear unmet needs in fibrosis as of 2026:

1. Compensated cirrhosis (F4 MASH): 89bio ENLIGHTEN-Cirrhosis (H1 2028 readout expected), Akero SYNCHRONY (F4 cohort) are the candidates. Label expansion timing will set the pace
2. PPF (Progressive Pulmonary Fibrosis, non-IPF): Nerandomilast PPF indication obtained; ALOFT-PPF (NCT06025578) is the next pivotal data point
3. Late-stage Renal Fibrosis: Existing drugs primarily preserve eGFR; no agent has demonstrated direct fibrosis regression. FGF21 and LPA1 expansion to renal indications under discussion
4. Cardiac Fibrosis: Large potential market in HFpEF. FAP (fibroblast activation protein)-targeted CAR-T approaches are advancing in preclinical research: autologous T-cell based proof-of-concept (Aghajanian et al. Nature 2019)²⁷, and in vivo mRNA-LNP CAR-T conversion (Rurik et al. Science 2022)²⁹. No clinical candidates yet established
5. Dermal/SSc: Beyond Tocilizumab and Nintedanib (SSc-ILD), no approved drugs; CABA-201 (CD19/BCMA dual CAR-T) and other autoimmune reprogramming strategies are emerging

8. Regional Dynamics

North America

Largest market (45-50% global share across all segments). FDA accelerated approval pathway has accelerated early approvals in IgA nephropathy and APOL1-mediated kidney disease. Center of M&A and licensing activity.

Europe

EMA conditional marketing authorization (Rezdiffra August 2025; Nerandomilast expected within 2026). Standard 6-12 month delay vs US approvals.

Japan

PMDA approval typically lags US by 12-18 months. Nerandomilast PMDA approval expected within 2026. Japan-originated fibrosis drug development remains early-stage (Otsuka OPC-163493 MASH; Daiichi Sankyo DS-2741 fibrosis exploration). Strategic options for Japanese pharma: (a) early-stage asset out-licensing, (b) Japan market rights acquisition for Phase 3 overseas candidates.

Asia (China, Korea)

China NMPA approved Nerandomilast PPF December 2025 (only 2 months after US) — a notable acceleration trend. Korea's Yuhan re-pivoting MASH program after Gilead partnership ended October 2024.

9. 2030 Forecasts and Investment Theses

Segment	Primary 2030 Drivers	Risk Scenarios
MASH	FGF21 analog Phase 3 readouts (2027-2028), GLP-1 combination approvals	Rezdiffra-as-SoC raises bar for add-on benefit (Gilead exit's structural cause)
IPF	Nerandomilast market penetration, Tyvaso label expansion, Admilparant Phase 3	Safety concerns (Bexotegrast-type), antifibrotic class effect scrutiny
CKD	Sparsentan follow-ons (Apecotrep et al.), Inaxaplin AMPLITUDE positivity, APOL1 platform consolidation	Atrasentan ALIGN p=0.057 traditional approval review risk, Iptacopan price negotiation
Pan-fibrotic	Cross-disease trials (IPF + SSc-ILD), FGF21 / LPA1 expansion to CKD/MASH	Indication-specific challenges, sample size constraints

10. Conclusion

2025-2026 in fibrosis drug development was a rare period when approvals, M&A, and pivotal readouts moved simultaneously. MASH entered the FGF21 era through $8B+ mega-deals; IPF received its first new approval in over a decade alongside the tension of pre-readout Phase 3 ALOFT trials; CKD saw three consecutive waves across IgA nephropathy, FSGS, and APOL1. Investment frameworks are shifting from "single-disease pipelines" to "cross-fibrotic-disease modalities and combination strategies". This article was updated on May 18, 2026, reflecting developments through the midpoint of ATS 2026 (May 16-21). Key updates: TETON-1 primary endpoint met March 30, 2026 (+130.1 mL FVC, p<0.0001, n=598), exceeding TETON-2; integrated TETON-1+TETON-2 analysis (+111.8 mL FVC) presented at ATS 2026 May 18; TETON-2 NEJM publication March 11, 2026 (PMID 41812190). Admilparant ALOFT-IPF and Nerandomilast EU/PMDA approvals remain pending for H2 2026.

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FAQ

The following Q&As mirror the frontmatter faq: field for AI Overview / featured snippet optimization.

Q1: How large is the global fibrosis treatment market in 2026? A: Per Data Bridge, the global Fibrotic Diseases Treatment market was USD 5.79B (2024) → USD 10.35B (2032), CAGR 7.6%¹. By disease (source/scope explicit): IPF treatment market USD 3.68B (2024) → USD 5.46B (2030) per Grand View Research, CAGR 6.8%³; global MASH/NASH treatment market USD 7.87B (2024) → USD 31.76B (2033) per DataM Intelligence, CAGR ~17.5%; F2-F3 segment USD 3.24B → USD 19.39B⁴; CKD drugs market USD 30.87B (2025) → USD 67.81B (2034) per Fortune Business Insights, CAGR 9.17%⁵. Scopes differ across firms; cite both source and scope alongside any figure.

Q2: What were the major fibrosis M&A deals in 2025-2026? A: MASH dominated: GSK acquired Boston Pharmaceuticals (efimosfermin, $1.2B + $0.8B milestones, May 2025), Roche acquired 89bio (pegozafermin, up to $3.5B total, Sep 2025), and Novo Nordisk acquired Akero (efruxifermin, $4.7B + $0.5B milestone, Oct 2025). All three on FGF21 analogs, totaling over $8B.

Q3: What is the peak sales forecast for Resmetirom (Rezdiffra)? A: Madrigal's company-reported figure is FY2025 net sales of ~US$958.4M (Q4 2025 US$321.1M)¹³. Separately, analyst consensus forecasts $1.245B (2026), $2.564B (2027), and peak annual sales of $3.4-3.5B — these are analyst projections rather than company guidance and should be cited as such. FDA accelerated approval March 2024 (first-ever MASH drug), EU conditional marketing authorization August 2025.

Q4: Which IPF/PPF approvals and Phase 3 readouts should I watch in 2026? A: (1) Nerandomilast (Boehringer, PDE4B inhibitor) — EU/UK/PMDA filing and approval trajectory is the next checkpoint (no firm public approval-date commitment as of May 2026), (2) Tyvaso (United Therapeutics) TETON-1 met primary endpoint March 30, 2026 (FVC +130.1 mL, p<0.0001); sNDA filing by end of summer 2026, (3) BMS-986278/Admilparant (BMS, LPA1 antagonist) ALOFT-IPF Phase 3 completion October 2026.

Q5: Where are the drug development opportunities in CKD/renal fibrosis? A: Three concurrent waves: IgA nephropathy (Atrasentan accelerated approval April 2025, Iptacopan APPLAUSE final March 2026), FSGS (Sparsentan FDA full approval April 2026 — first DMT), APOL1-mediated kidney disease (Inaxaplin AMPLITUDE Phase 2/3 adaptive trial, interim ~September 2026).

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Related Articles

• MASH Drug Landscape 2025: $8B Mega-Deals & FGF21 Pipeline
• MASH Combination Therapy Strategies 2026
• IPF Pipeline 2025-2026: Approvals, Failures & Outlook
• CKD Antifibrotic Landscape 2026: IgA, FSGS, APOL1 Three Waves
• Sparsentan FSGS Approval 2026-04: First Disease-Modifying Therapy
• Nerandomilast (PDE4B Inhibitor): Mechanism, Clinical Data & Preclinical Evidence
• BMS-986278 (Admilparant, LPA1 Antagonist): IPF/PPF Pipeline
• Anti-Fibrotic Drug Pipeline 2026: Cross-Disease Approaches

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References

1. Fibrotic Diseases Treatment Market — Global Forecast to 2032 — Data Bridge Market Research

2. Antifibrotic Drug Market Size & Share 2025-2030 — 360i Research

3. Idiopathic Pulmonary Fibrosis Treatment Market — Grand View Research

4. NASH/MASH Treatment Market Forecast 2026-2034 — DataM Intelligence

5. Chronic Kidney Disease Drugs Market 2026-2034 — Fortune Business Insights

6. FDA Approves FILSPARI (sparsentan) for Adults and Pediatric Patients with FSGS — Travere Therapeutics Press Release (2026-04-13)

7. Boehringer Ingelheim Press Release: U.S. FDA approves JASCAYD® (nerandomilast) as first new treatment option for adults with IPF in over a decade (2025-10-09). FDA label via DailyMed Jascayd (PPF indication added 12/2025; revised 02/2026).

8. Novo Nordisk to acquire Akero Therapeutics for up to USD 5.2 billion — Novo Nordisk Press Release (2025-10-09)

9. Barratt J, et al. Iptacopan in IgA Nephropathy — Final 24-Month Data (APPLAUSE-IgAN Phase 3). N Engl J Med. 2026. PubMed 41910396 (DOI: 10.1056/NEJMoa2600743). Novartis PR (2026-03-29, published simultaneously with WCN 2026 late-breaking): Novartis

10. Pliant Therapeutics Provides Update on BEACON-IPF (Final Discontinuation) — Press Release (2025-06-27)

11. GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine for SLD — GSK Press Release (2025-05-14)

12. Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH — Roche Media Release (2025-09-18)

13. Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Financial Results — Madrigal Press Release (Rezdiffra FY2025 net sales ~$1B, Q4 2025 $321.1M; peak sales projections are analyst consensus, not company guidance)

14. FDA Approves Treatment for Serious Liver Disease Known as 'MASH' — U.S. FDA News (Wegovy semaglutide, 2025-08)

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24. FIBRONEER-IPF Trial (NCT05321069) — ClinicalTrials.gov

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