Drugs / Efzofitimod
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT03824392 | Jan 2019 → Jun 2021 | pulmonary sarcoidosis | aTyr Pharma, Inc. | Completed | Met primary |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05892614 | Oct 2023 → Apr 2026 overdue | interstitial lung disease | aTyr Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04412668 | Jun → Oct 2020 | COVID-19 | aTyr Pharma, Inc. | Completed | Met primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT05415137 | Sep 2022 → Jun 2025 | pulmonary sarcoidosis | aTyr Pharma, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | aTyr Pharma, Inc. | Results aTyr Pharma to Present Subgroup Analysis of Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis at WASOG 2026 atyrpharma.com ↗
Patients with restrictive lung disease demonstrate clinically meaningful benefit in FVC and improvements in multiple PROs for 5.0 mg/kg efzofitimod compared to placebo. |
| 2025-09-30 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Additional Findings from Phase 3 EFZO-FIT™ Study in Late-Breaking Oral Abstract at the European Respiratory Society (ERS) Congress 2025 atyrpharma.com ↗
Improvement in Fatigue Assessment Scale Total Score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0226). |
| 2025-09-16 | Kyorin Pharmaceutical Co.,Ltd | Results 間質性肺疾患治療薬「KRP-R120」の第3相臨床試験結果のお知らせ kyorin-pharm.co.jp ↗
その結果、主要評価項目である「経口ステロイド（OCS）漸減終了後における OCS の 1 日平均投与量のベースラインからの変化量」において、プラセボと比較し統計学的に有意な差が認められず、主要評価項目は達成されませんでした（p=0.3313）。 |
| 2025-09-15 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Topline Results from Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis atyrpharma.com ↗
The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid (OCS) dose at week 48. |
| 2025-06-04 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Findings from Interim Analysis of Ongoing Phase 2 EFZO-CONNECT™ Study of Efzofitimod in Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) atyrpharma.com ↗
Three out of four efzofitimod-treated diffuse SSc-ILD patients showed clinically important improvement based on the modified Rodnan Skin Score (mRSS) assessment at 12 weeks. |
| 2025-05-19 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Three Posters on Efzofitimod at the American Thoracic Society (ATS) 2025 International Conference atyrpharma.com ↗
Blinded baseline demographics and disease characteristics for ongoing Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis largely balanced and representative of targeted trial population. |
| 2025-03-12 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Publication Demonstrating Efzofitimod’s Immunomodulatory Activity in Science Translational Medicine atyrpharma.com ↗
This peer-reviewed publication in a highly regarded journal such as Science Translational Medicine validates the immunomodulatory activity and extracellularly mediated mechanism of efzofitimod in reducing inflammation and fibrosis. |
| 2025-03-06 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Fourth Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis atyrpharma.com ↗
The DSMB recommended that the study continue without any modifications. |
| 2024-12-10 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Third Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis atyrpharma.com ↗
The DSMB recommended that the study continue without any modifications. |
| 2024-10-02 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Publication Demonstrating Efficacy of Efzofitimod in Pulmonary Sarcoidosis in the European Respiratory Journal atyrpharma.com ↗
Post hoc analysis of Phase 1b/2a study demonstrated statistically significant difference in time-to-first-relapse for corticosteroid use in therapeutic (3.0 and 5.0 mg/kg efzofitimod) vs subtherapeutic (1.0 mg/kg efzofitimod and placebo) groups. |
| 2024-05-14 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Second Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis atyrpharma.com ↗
Independent data and safety monitoring board (DSMB) recommends continuation of study without any modifications. |
| 2024-01-29 | aTyr Pharma, Inc. | Results aTyr Pharma to Present Posters Highlighting Importance of Neuropilin-2 in Immune Regulation at Keystone Symposia on Myeloid Cell Diversity atyrpharma.com ↗
Findings further demonstrate that efzofitimod modulates myeloid cells via the neuropilin-2 (NRP2) receptor to promote a unique anti-inflammatory mechanism. |
| 2023-11-13 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Poster Demonstrating Preclinical Effects of Efzofitimod in Rheumatoid Arthritis and Rheumatoid Arthritis-Associated ILD at the ACR Convergence 2023 atyrpharma.com ↗
Efzofitimod demonstrated immune regulatory function improving disease outcomes and mitigating fibrosis in animal models. |
| 2023-09-11 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, FVC and Patient Reported Outcomes atyrpharma.com ↗
aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. |
| 2023-06-22 | aTyr Pharma, Inc. | Regulatory European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Systemic Sclerosis atyrpharma.com ↗
the European Commission (EC) granted orphan drug designation for the company’s lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, or scleroderma) |
| 2023-05-22 | aTyr Pharma, Inc. | Results aTyr Pharma Presents New Data on Efzofitimod Mechanism of Action and Positive Exposure-Response at the American Thoracic Society 2023 International Conference atyrpharma.com ↗
Exposure-efficacy data from Phase 1b/2a study of efzofitimod support efficacy across multiple clinically relevant endpoints in pulmonary sarcoidosis patients. |
| 2023-01-18 | aTyr Pharma, Inc. | Regulatory European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Sarcoidosis atyrpharma.com ↗
aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the European Commission (EC) granted orphan drug designation for the company’s lead therapeutic candidate, efzofitimod, for the treatment of sarcoidosis based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). |
| 2022-11-09 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Publication of Positive Data from Phase 1b/2a Clinical Study of Efzofitimod for the Treatment of Pulmonary Sarcoidosis in the Journal CHEST atyrpharma.com ↗ |
| 2022-09-13 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod for Treatment of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) atyrpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD). |
| 2022-08-11 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod (ATYR1923) for Treatment of Pulmonary Sarcoidosis atyrpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for its lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis |
| 2022-05-17 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Clinical Data for Efzofitimod (ATYR1923) at the American Thoracic Society 2022 International Conference atyrpharma.com ↗
Results from Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis patients demonstrate dose-dependent improvements in key physiologic and quality of life measures in context of a steroid taper. |
| 2022-04-13 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Announces FDA Orphan Drug Designation for Efzofitimod (ATYR1923) for Treatment of Systemic Sclerosis atyrpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, also known as scleroderma). |
| 2022-04-01 | aTyr Pharma, Inc. | Results aTyr Pharma to Present Clinical Data for Efzofitimod (ATYR1923) at the American Thoracic Society 2022 International Conference atyrpharma.com ↗
Results from Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis patients demonstrate safety and dose dependent trends of improvement compared to placebo for key efficacy endpoints. |
| 2022-01-13 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Advances Development of Lead Therapeutic Candidate ATYR1923 with Announcement of “efzofitimod” as Nonproprietary Name atyrpharma.com ↗
the United States Adopted Names (USAN) Council and the World Health Organization’s (WHO) International Nonproprietary Name (INN) Expert Committee have selected the nonproprietary name efzofitimod for ATYR1923 |
| 2022-01-06 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Announces FDA Orphan Drug Designation for ATYR1923 for Treatment of Sarcoidosis atyrpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for its lead therapeutic candidate, ATYR1923, for the treatment of sarcoidosis. |
| 2021-09-13 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Positive Data from Phase 1b/2a Clinical Trial Demonstrating Consistent Dose Response for ATYR1923 in Pulmonary Sarcoidosis atyrpharma.com ↗
ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. |
| 2021-03-15 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Positive Biomarker Data from Phase 2 Clinical Trial of ATYR1923 Demonstrating Anti-Inflammatory Effects in COVID-19 Patients with Severe Respiratory Complications atyrpharma.com ↗
Patients treated with ATYR1923 demonstrated a trend of overall improvement in key biomarkers analyzed compared to placebo. |
| 2021-01-04 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Positive Topline Results from Phase 2 Clinical Trial of ATYR1923 in COVID-19 Patients with Severe Respiratory Complications atyrpharma.com ↗ |
| 2020-08-11 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Proceeds to Phase 1 Trial of ATYR1923 in Japan atyrpharma.com ↗
The CTN permits the start of clinical development activities in Japan for ATYR1923. |
| 2020-05-05 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Publication of Two Abstracts in American Journal of Respiratory and Critical Care Medicine atyrpharma.com ↗
One abstract characterizes the molecular basis for ATYR1923’s immunomodulatory properties, including its ability to specifically and selectively bind to NRP2, a target that has been implicated in a broad range of immune-mediated diseases. |
| 2020-04-21 | aTyr Pharma, Inc. | Regulatory aTyr Pharma Announces Phase 2 Study of ATYR1923 in COVID-19 Patients with Severe Respiratory Complications Following FDA Acceptance of IND Application atyrpharma.com ↗
the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its lead therapeutic candidate, ATYR1923, in a Phase 2 study in COVID-19 patients with severe respiratory complications. |
| 2019-12-12 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Positive Interim Safety Results from Ongoing Phase 1b/2a Clinical Trial of ATYR1923 atyrpharma.com ↗ |
| 2019-04-08 | aTyr Pharma, Inc. | Results aTyr Pharma to Present Poster at the American Thoracic Society 2019 International Conference atyrpharma.com ↗ |
| 2019-02-27 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Compelling Preclinical Data Highlighting Potential of ATYR1923 to Regulate Myeloid Cell Biology During Lung Inflammation atyrpharma.com ↗ |
| 2018-07-26 | aTyr Pharma, Inc. | Results aTyr Pharma Presents Positive Lung and Skin Findings with ATYR1923 in a Translational Animal Model at the Scleroderma Foundation National Patient Education Conference atyrpharma.com ↗
The presentation reviews the positive lung and skin results of a recently completed murine experiment evaluating low doses of ATYR1923 in a chronic graft versus host disease model of systemic sclerosis. |
| 2018-06-26 | aTyr Pharma, Inc. | Results aTyr Pharma Announces Positive Phase 1 Data for ATYR1923 Therapeutic Candidate atyrpharma.com ↗
The results indicate that the drug was generally well-tolerated at all dose levels tested, with no significant adverse events or induction of anti-drug antibodies observed following ATYR1923 dosing or throughout the one-month follow-up period. |
All press releases naming this drug 69 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efzofitimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04412668 ↗ |
| Known as | ATYR1923 | “Efzofitimod (ATYR1923), a novel immunomodulator, selectively binds neuropilin 2, which is upregulated on immune cells in response to lung inflammation.” PMID 36356657 ↗ Nov 20221“Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19” NCT04412668 ↗ |
| Route | Intravenous | “efzofitimod administered intravenously every 4 weeks for 24 weeks” PMID 36356657 ↗ Nov 2022 |
| Target | NRP2 | “selectively binds neuropilin 2” PMID 36356657 ↗ Nov 2022 |