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Asset Brief

AD-214

1AD·Adalta·Idiopathic pulmonary fibrosis (IPF) — a progressive scarring disease of the lungs with no cure·Phase 1·NCT05914909·Primary completion: 9 Feb 2024

Plain-language Brief

The trial in plain terms

The disease: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive condition in which scar tissue (fibrosis) builds up in the lungs, making it harder to breathe over time. The cause is unknown, and the disease is ultimately fatal. IPF affects an estimated 3 million people worldwide (per Orphan Drug Designation basis commonly cited in the literature) and carries a median survival of 2-5 years from diagnosis (per Raghu et al, American Journal of Respiratory and Critical Care Medicine 2022). The U.S. Food and Drug Administration (FDA) has granted AD-214 Orphan Drug Designation for IPF (per Adalta ASX disclosures).
What the asset is trying to do: AD-214 is a CXCR4 antagonist Fc-fusion protein, meaning it is an engineered protein designed to block the CXCR4 receptor, which is involved in signalling pathways linked to inflammation and fibrosis (scarring). It is built on Adalta's i-body platform, which uses a small, stable protein scaffold derived from a shark antibody domain fused to an antibody Fc region to extend its time in the body. Unlike small-molecule CXCR4 inhibitors, this Fc-fusion format is a biologic and is administered by injection rather than taken orally. The i-body scaffold is described by Adalta as distinct from conventional monoclonal antibody formats (per Adalta investor materials).
What the trial is measuring, and why it matters: The completed Phase 1 trials (NCT04415671 and NCT05914909) were designed to assess safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (what the drug does to the body) in healthy volunteers and patients with interstitial lung disease, including IPF (per ClinicalTrials.gov NCT05914909 and NCT04415671). These early-phase endpoints are standard first steps before moving into trials that measure whether the drug actually slows or stops disease progression. Adalta has disclosed that the Phase 1 extension study achieved positive safety results at the intended Phase 2 dose (per Adalta ASX disclosures).
Efficacy benchmarks in this setting: The two approved antifibrotic therapies for IPF are pirfenidone (Esbriet) and nintedanib (Ofev). In the ASCEND trial, pirfenidone reduced the annual rate of decline in forced vital capacity (FVC, a measure of lung function) compared with placebo (King et al, New England Journal of Medicine 2014). In the INPULSIS trials, nintedanib also reduced the annual rate of FVC decline versus placebo (Richeldi et al, New England Journal of Medicine 2014). Neither therapy reverses fibrosis, and neither is considered curative. AD-214's Phase 1 programme measured safety and pharmacology endpoints only; the figures reported for approved therapies in registrational trials are not statistically comparable to data from a Phase 1 safety study.

Trial Design

Design summary

Phase: Phase 1
Design type: Open-label and placebo-controlled cohorts; Phase 1 dose-escalation in healthy volunteers and patients with interstitial lung disease. Single-centre or multi-centre status [ TODO: fill in ].
Primary endpoint: Safety and tolerability (per ClinicalTrials.gov NCT05914909 and NCT04415671)
Key secondary endpoints: Pharmacokinetics (PK) — how the drug is absorbed, distributed, and eliminated (per ClinicalTrials.gov NCT05914909)
Pharmacodynamics (PD) — biological effects of the drug on the body (per ClinicalTrials.gov NCT05914909)
Enrolment target: 8 patients in the extension cohort (per ClinicalTrials.gov NCT05914909); 50 participants in the original Phase 1 (per ClinicalTrials.gov NCT04415671)
Current enrolment status: Both trials listed as Completed (per ClinicalTrials.gov NCT05914909 and NCT04415671)
Sites: [ TODO: fill in ]
Expected readout window: Both Phase 1 trials are completed with primary completion dates of 2021-10-21 (NCT04415671) and 2024-02-09 (NCT05914909) respectively (per ClinicalTrials.gov). Adalta has disclosed positive safety data at the Phase 2 dose from the extension study (per Adalta ASX disclosures). A Phase 2 readout window is not determinable from available data as Phase 2 has not commenced and a partner has not been disclosed.

Asset Track Record

Did 1AD deliver against its own guidance?

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

1 July 2026partnershipOktopi AI collaboration for research efficiencyhitsrc ASX ↗
15 June 2026regulatory decisionShareholder approval at EGM for options offerhitsrc ASX ↗
24 May 2026regulatory decisionBZDS1901 FDA — Regulatory advisors appointed for BZDS1901hit · positivesrc ASX ↗
24 May 2026otherProspectushitsrc ASX ↗
3 May 2026financing$2.5m placementhitsrc ASX ↗
3 May 2026financingProposed issue of securities - 1ADhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for AD-214 and peers

AD-214'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 AD-214. Showing past 6 months and next 12 months · 9 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

Trial design comparison

How AD-214 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
AD-214	Adalta	Fc Fusion Protein	Phase 1[ TODO: fill in ]	Open-label and placebo-controlled cohorts; Phase 1 dose-escalation in healthy volunteers and patients with interstitial lung disease. Single-centre or multi-centre status [ TODO: fill in ].	Safety and tolerability (per ClinicalTrials.gov NCT05914909 and NCT04415671)	[ TODO: fill in ]	8 patients in the extension cohort (per ClinicalTrials.gov NCT05914909); 50 participants in the original Phase 1 (per ClinicalTrials.gov NCT04415671)	8

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 AD-214 yet. Broker coverage of Adalta 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 1AD deliver against its own guidance?

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

1 July 2026partnershipOktopi AI collaboration for research efficiencyhitsrc ASX ↗
15 June 2026regulatory decisionShareholder approval at EGM for options offerhitsrc ASX ↗
24 May 2026regulatory decisionBZDS1901 FDA — Regulatory advisors appointed for BZDS1901hit · positivesrc ASX ↗
24 May 2026otherProspectushitsrc ASX ↗
3 May 2026financing$2.5m placementhitsrc ASX ↗
3 May 2026financingProposed issue of securities - 1ADhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for AD-214 and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

Trial design comparison

How AD-214 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
AD-214	Adalta	Fc Fusion Protein	Phase 1[ TODO: fill in ]	Open-label and placebo-controlled cohorts; Phase 1 dose-escalation in healthy volunteers and patients with interstitial lung disease. Single-centre or multi-centre status [ TODO: fill in ].	Safety and tolerability (per ClinicalTrials.gov NCT05914909 and NCT04415671)	[ TODO: fill in ]	8 patients in the extension cohort (per ClinicalTrials.gov NCT05914909); 50 participants in the original Phase 1 (per ClinicalTrials.gov NCT04415671)	8

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

AD-214n = 8

Adalta·Fc Fusion Protein·Phase 1·[ TODO: fill in ]

Design: Open-label and placebo-controlled cohorts; Phase 1 dose-escalation in healthy volunteers and patients with interstitial lung disease. Single-centre or multi-centre status [ TODO: fill in ].
Primary endpoint: Safety and tolerability (per ClinicalTrials.gov NCT05914909 and NCT04415671)
Dosing: [ TODO: fill in ]
Eligibility: 8 patients in the extension cohort (per ClinicalTrials.gov NCT05914909); 50 participants in the original Phase 1 (per ClinicalTrials.gov NCT04415671)

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazolen = —

Norfolk and Norwich University Hospitals NHS Foundation Trust·—·Phase 3

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

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosisn = —

Fondation Hôpital Saint-Joseph·—·Phase 3

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

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Diseasen = —

United Therapeutics·—·Phase 3

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

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosisn = —

Bristol-Myers Squibb·—·Phase 3

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

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilastn = —

Boehringer Ingelheim·—·Phase 3

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosisn = —

Haisco Pharmaceutical Group Co., Ltd.·—·Phase 3

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

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosisn = —

Argyrios Tzouvelekis·—·Phase 3

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

Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosisn = —

University of Massachusetts, Worcester·—·Phase 3

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

Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)n = —

PureTech·—·Phase 3

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

A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)n = —

Beijing Tide Pharmaceutical Co., Ltd·—·Phase 3

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

Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosisn = —

Bristol-Myers Squibb·—·Phase 3

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

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPFn = —

Sunshine Lake Pharma Co., Ltd.·—·Phase 3

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

Anlotinib Capsules in the Treatment for IPF/PF-ILDsn = —

First Affiliated Hospital of Wenzhou Medical University·—·PHASE2/PHASE3

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

SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)n = —

Guangzhou JOYO Pharma Co., Ltd·—·PHASE2/PHASE3

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

Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosisn = —

Redx Pharma Ltd·—·Phase 2

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

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)n = —

PureTech·—·Phase 2

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

Genentech Xenon MRI Idiopathic Pulmonary Fibrosisn = —

Duke University·—·Phase 2

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

Phase ll Study of HEC585 in Patients With IPFn = —

Sunshine Lake Pharma Co., Ltd.·—·Phase 2

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

Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)n = —

Melius Pharma AB·—·Phase 2

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

Xenon MRI and Progressive ILDn = —

Duke University·—·Phase 2

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

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosisn = —

InSilico Medicine Hong Kong Limited·—·Phase 2

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

Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosisn = —

Haisco Pharmaceutical Group Co., Ltd.·—·Phase 2

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

SB17170 Phase 2 Trial in IPF Patientsn = —

SPARK Biopharma·—·Phase 2

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

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Bloodn = —

Boehringer Ingelheim·—·Phase 2

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

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)n = —

Syndax Pharmaceuticals·—·Phase 2

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

A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)n = —

Endeavor Biomedicines, Inc.·—·Phase 2

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

Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPFn = —

Daewoong Pharmaceutical Co. LTD.·—·Phase 2

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

Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)n = —

Haisco Pharmaceutical Group Co., Ltd.·—·Phase 2

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

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnessesn = —

Reunion Neuroscience Inc·—·Phase 2

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

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPFn = —

Avalyn Pharma Inc.·—·Phase 2

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

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosisn = —

Shanghai Synvida Biotechnology Co.,Ltd.·—·Phase 2

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

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)n = —

Cumberland Pharmaceuticals·—·Phase 2

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

Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosisn = —

Cedars-Sinai Medical Center·—·Phase 2

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

Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseasesn = —

Erasme University Hospital·—·Phase 2

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

A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatmentn = —

Boehringer Ingelheim·—·Phase 2

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

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.n = —

Vicore Pharma AB·—·Phase 2

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

A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosisn = —

Calluna Pharma AS·—·Phase 2

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

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)n = —

Mediar Therapeutics·—·Phase 2

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

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosisn = —

Rein Therapeutics·—·Phase 2

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

H01 in Adults With Interstitial Lung Disease (The SOLIS Study)n = —

National Institute of Environmental Health Sciences (NIEHS)·—·Phase 2

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

A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosisn = —

Chiesi Farmaceutici S.p.A.·—·Phase 2

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

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosisn = —

Contineum Therapeutics·—·Phase 2

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

Menstrual Blood-Derived Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosisn = —

Ruijin Hospital·—·Phase 2

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

Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Diseasen = —

Vejle Hospital·—·Phase 2

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

Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosisn = —

Dragonboat Biopharmaceutical Company Limited·—·Phase 2

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

Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosisn = —

AbbVie·—·Phase 2

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

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)n = —

Avalyn Pharma Inc.·—·Phase 2

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

Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosisn = —

National Jewish Health·—·PHASE1/PHASE2

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

Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failuren = —

Paul Szabolcs·—·PHASE1/PHASE2

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

NA
Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Phase 3
Norfolk and Norwich University Hospitals NHS Foundation Trust·Recruiting·Primary completion 28 Feb 2026·NCT04965298
FH
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Phase 3
Fondation Hôpital Saint-Joseph·Recruiting·Primary completion 30 Mar 2026·NCT05674994
U
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
Phase 3
United Therapeutics·ENROLLING_BY_INVITATION·Primary completion 1 June 2026·NCT04905693
BS
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Phase 3
Bristol-Myers Squibb·Active, not recruiting·Primary completion 6 Oct 2026·NCT06003426
BI
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Phase 3
Boehringer Ingelheim·Recruiting·Primary completion 28 Apr 2027·NCT06238622
HP
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis
Phase 3
Haisco Pharmaceutical Group Co., Ltd.·Not yet recruiting·Primary completion 5 Apr 2028·NCT07519070
AT
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Phase 3
Argyrios Tzouvelekis·Recruiting·Primary completion 1 June 2028·NCT07299695
UO
Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
Phase 3
University of Massachusetts, Worcester·Not yet recruiting·Primary completion 15 Mar 2029·NCT07520110
P
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Phase 3
PureTech·Recruiting·Primary completion 1 June 2029·NCT07284602
BT
A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Phase 3
Beijing Tide Pharmaceutical Co., Ltd·Recruiting·Primary completion 30 July 2029·NCT07464912
BS
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Phase 3
Bristol-Myers Squibb·Not yet recruiting·Primary completion 22 Nov 2029·NCT07441408
SL
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
Phase 3
Sunshine Lake Pharma Co., Ltd.·Recruiting·Primary completion 15 Jan 2031·NCT07082842
FA
Anlotinib Capsules in the Treatment for IPF/PF-ILDs
PHASE2/PHASE3
First Affiliated Hospital of Wenzhou Medical University·Recruiting·Primary completion 4 Mar 2026·NCT05828953
GJ
SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
PHASE2/PHASE3
Guangzhou JOYO Pharma Co., Ltd·Recruiting·Primary completion 31 Dec 2026·NCT06125327
RP
Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
Phase 2
Redx Pharma Ltd·Active, not recruiting·Primary completion 25 June 2024·NCT05570058
P
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
PureTech·Active, not recruiting·Primary completion 15 Oct 2024·NCT05321420
DU
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Phase 2
Duke University·Active, not recruiting·Primary completion 17 Oct 2024·NCT04071769
SL
Phase ll Study of HEC585 in Patients With IPF
Phase 2
Sunshine Lake Pharma Co., Ltd.·Active, not recruiting·Primary completion 16 July 2025·NCT05060822
MP
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
Phase 2
Melius Pharma AB·Active, not recruiting·Primary completion 1 Aug 2025·NCT05983471
DU
Xenon MRI and Progressive ILD
Phase 2
Duke University·Active, not recruiting·Primary completion 3 Nov 2025·NCT05241275
IM
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
Phase 2
InSilico Medicine Hong Kong Limited·Recruiting·Primary completion 28 Feb 2026·NCT05975983
HP
Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis
Phase 2
Haisco Pharmaceutical Group Co., Ltd.·Not yet recruiting·Primary completion 30 Apr 2026·NCT06764862
SB
SB17170 Phase 2 Trial in IPF Patients
Phase 2
SPARK Biopharma·Recruiting·Primary completion 30 May 2026·NCT06747923
BI
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
Phase 2
Boehringer Ingelheim·Recruiting·Primary completion 4 Aug 2026·NCT06241560
S
MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
Syndax Pharmaceuticals·Active, not recruiting·Primary completion 1 Sept 2026·NCT06132256
EB
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
Phase 2
Endeavor Biomedicines, Inc.·Active, not recruiting·Primary completion 1 Oct 2026·NCT06422884
DP
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Phase 2
Daewoong Pharmaceutical Co. LTD.·Recruiting·Primary completion 13 Oct 2026·NCT05389215
HP
Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
Haisco Pharmaceutical Group Co., Ltd.·Not yet recruiting·Primary completion 31 Oct 2026·NCT07019090
RN
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Phase 2
Reunion Neuroscience Inc·Recruiting·Primary completion 1 Nov 2026·NCT07002034
AP
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Phase 2
Avalyn Pharma Inc.·Recruiting·Primary completion 1 Dec 2026·NCT07194382
SS
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
Phase 2
Shanghai Synvida Biotechnology Co.,Ltd.·Recruiting·Primary completion 31 Dec 2026·NCT07121413
C
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
Cumberland Pharmaceuticals·Recruiting·Primary completion 1 Jan 2027·NCT05571059
CC
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
Phase 2
Cedars-Sinai Medical Center·Recruiting·Primary completion 1 Jan 2027·NCT06567717
EU
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Phase 2
Erasme University Hospital·Recruiting·Primary completion 9 Mar 2027·NCT06189820
BI
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Phase 2
Boehringer Ingelheim·Recruiting·Primary completion 28 Apr 2027·NCT07036523
VP
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Phase 2
Vicore Pharma AB·Active, not recruiting·Primary completion 1 May 2027·NCT06588686
CP
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Phase 2
Calluna Pharma AS·Recruiting·Primary completion 1 Aug 2027·NCT06736990
M
WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
Mediar Therapeutics·Recruiting·Primary completion 1 Aug 2027·NCT06967805
R
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Phase 2
Rein Therapeutics·Recruiting·Primary completion 30 Sept 2027·NCT06968845
NI
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Phase 2
National Institute of Environmental Health Sciences (NIEHS)·Recruiting·Primary completion 31 Dec 2027·NCT06325696
CF
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
Phase 2
Chiesi Farmaceutici S.p.A.·Not yet recruiting·Primary completion 12 Feb 2028·NCT07516951
C
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Phase 2
Contineum Therapeutics·Recruiting·Primary completion 1 May 2028·NCT07284459
RH
Menstrual Blood-Derived Mesenchymal Stem Cell Injection (SC01009) in the Treatment of Idiopathic Pulmonary Fibrosis
Phase 2
Ruijin Hospital·Not yet recruiting·Primary completion 31 July 2028·NCT07131150
VH
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
Phase 2
Vejle Hospital·Recruiting·Primary completion 1 Dec 2028·NCT06714123
DB
Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
Phase 2
Dragonboat Biopharmaceutical Company Limited·Not yet recruiting·Primary completion 1 Apr 2029·NCT07447102
A
Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis
Phase 2
AbbVie·Recruiting·Primary completion 1 Sept 2029·NCT07230288
AP
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Phase 2
Avalyn Pharma Inc.·Recruiting·Primary completion 31 Dec 2031·NCT06951217
NJ
Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis
PHASE1/PHASE2
National Jewish Health·Active, not recruiting·Primary completion 15 Sept 2024·NCT04598919
PS
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
PHASE1/PHASE2
Paul Szabolcs·Recruiting·Primary completion 1 Dec 2027·NCT03500731