This section highlights FDA-related milestones and regulatory updates for drugs developed by FibroGen (FGEN).
Over the past two years, FibroGen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FG-3165, FG-3246, and roxadustat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
FG-3165 FDA Regulatory Events
FG-3165 is a drug developed by FibroGen for the following indication: for treatment of solid tumors characterized by high Gal9 levels of expression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FG-3165
- Announced Date:
- June 3, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- for treatment of solid tumors characterized by high Gal9 levels of expression.
Announcement
FibroGen, announced Plan to begin enrollment in 2H 2024
AI Summary
FibroGen announced plans to begin enrollment for its Phase 1 trial in the second half of 2024 for FG-3165, an anti-galectin-9 monoclonal antibody. The trial will test FG-3165 both as a standalone treatment and in combination with Regeneron’s LIBTAYO® (cemiplimab) in patients with select solid tumors.
The study is designed to evaluate the safety and potential added benefits of pairing FG-3165 with LIBTAYO®, given the promising synergistic effects observed in preclinical studies. By targeting galectin-9, a molecule that affects immune checkpoint activity, FG-3165 may enhance the body’s natural tumor-killing capabilities. This enrollment phase marks an important step in advancing FibroGen’s immuno-oncology program, with the goal of improving clinical outcomes for patients battling solid tumors.
Read Announcement- Drug:
- FG-3165
- Announced Date:
- June 3, 2024
- Indication:
- for treatment of solid tumors characterized by high Gal9 levels of expression.
Announcement
FibroGen announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.
AI Summary
FibroGen announced that the FDA has cleared its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody designed to target galectin-9 (Gal9). Gal9 is known to suppress the activation of T cells and natural killer cells and is overexpressed in certain solid tumors. By binding with high affinity to Gal9, FG-3165 is intended to inhibit its role in immune cell suppression, thereby enhancing the body’s ability to attack tumor cells. This clearance is a significant milestone, as it paves the way for early-stage clinical trials to assess the safety and potential effectiveness of FG-3165 in patients with solid tumors that exhibit high levels of Gal9. The company believes that this approach could improve clinical outcomes and hopes that future studies will confirm its benefit as a monotherapy or in combination with other immunotherapies.
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FG-3246 FDA Regulatory Timeline and Events
FG-3246 is a drug developed by FibroGen for the following indication: In Patients with Metastatic Castration-Resistant Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FG-3246
- Announced Date:
- March 28, 2025
- Indication:
- In Patients with Metastatic Castration-Resistant Prostate Cancer
Announcement
FibroGen announced the peer-reviewed publication titled "A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer" in the Journal of Clinical Oncology.
AI Summary
FibroGen recently announced the publication of a peer-reviewed paper in the Journal of Clinical Oncology detailing the Phase 1, first-in-human study of FG-3246—an immune-modulating antibody-drug conjugate targeting CD46—in patients with metastatic castration-resistant prostate cancer. The study, sponsored by Fortis Therapeutics, included heavily pre-treated patients and provided complete results showing promising anti-cancer activity with an acceptable safety profile. Key findings identified a maximally tolerated dose of 2.7 mg/kg and reported manageable adverse events such as infusion reactions, neutropenia, and peripheral neuropathy. The data suggests that targeting CD46 could offer a new treatment approach for this difficult-to-treat form of prostate cancer. Building on these encouraging results, FibroGen plans to initiate a Phase 2 monotherapy dose optimization study by mid-2025 to further explore FG-3246’s potential in this clinical setting.
Read Announcement- Drug:
- FG-3246
- Announced Date:
- June 18, 2024
- Indication:
- In Patients with Metastatic Castration-Resistant Prostate Cancer
Announcement
FibroGen, Inc. announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET.
AI Summary
FibroGen, Inc. announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. This investor-only event will feature Rahul Aggarwal, M.D. from the University of California San Francisco. Dr. Aggarwal will discuss the unmet need and evolving treatment landscape in prostate cancer, with special focus on metastatic castration-resistant prostate cancer (mCRPC).
The presentation will highlight FibroGen’s clinical development program for FG-3246, a CD46-targeting antibody-drug conjugate with first-in-class potential. The company plans to initiate a Phase 2 monotherapy trial in the second half of 2024. Additionally, data from an earlier Phase 1b/2 study investigating FG-3246 in combination with enzalutamide will be reviewed. A live question and answer session will follow the formal presentation, offering a chance for direct investor engagement.
Read Announcement- Drug:
- FG-3246
- Announced Date:
- May 23, 2024
- Indication:
- In Patients with Metastatic Castration-Resistant Prostate Cancer
Announcement
FibroGen announced positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
FibroGen announced encouraging interim results from the dose escalation phase of an investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco. The trial evaluated FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate with an MMAE payload, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The study reported a median radiographic progression-free survival of 10.2 months in biomarker unselected patients. Researchers established a recommended Phase 2 dose of 2.1 mg/kg every three weeks for FG-3246, combined with the standard 160 mg daily dose of enzalutamide. The combination also showed an acceptable safety profile, with adverse effects similar to those seen with other MMAE-based ADC treatments. These promising early results, presented at the 2024 ASCO Annual Meeting, support further exploration of this novel therapeutic strategy for advanced prostate cancer.
Read Announcement
Roxadustat FDA Regulatory Events
Roxadustat is a drug developed by FibroGen for the following indication: Anemia of chronic kidney disease (CKD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- roxadustat
- Announced Date:
- August 7, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- Anemia of chronic kidney disease (CKD)
Announcement
FibroGen announced that Company intends to file the Phase 3 protocol in the fourth quarter of 2025
AI Summary
FibroGen Inc. announced that it plans to file the Phase 3 trial protocol for roxadustat in the fourth quarter of 2025. The trial will test roxadustat in patients with lower-risk myelodysplastic syndromes who need high red blood cell transfusion support.
Agreement has been reached with the FDA on key trial design elements. The study will enroll about 200 patients who require at least four packed red blood cell units over two consecutive 8-week periods and who cannot use or did not respond to other anemia treatments. It will be a randomized, double-blind, placebo-controlled trial. The primary endpoint may be 8- or 16-week transfusion independence.
FDA and FibroGen also aligned on dosing strategies and rules to manage thrombotic risk. Roxadustat’s oral route and tolerability profile could offer an important new option for patients facing heavy transfusion burdens and unmet needs in anemia treatment.
Read Announcement- Drug:
- roxadustat
- Announced Date:
- August 7, 2025
- Indication:
- Anemia of chronic kidney disease (CKD)
Announcement
FibroGen announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial.
AI Summary
FibroGen announced positive feedback from its Type C meeting with the FDA for a pivotal Phase 3 trial of oral roxadustat in lower-risk myelodysplastic syndrome (LR-MDS) patients who have a high red blood cell transfusion burden. This follows a post-hoc subgroup analysis of the MATTERHORN study.
In that analysis, 36% of high-burden patients on roxadustat achieved 56 days of independence versus 7% on placebo (p=0.041). The FDA agreed on key design points like enrolling patients needing ≥4 units in two 8-week periods, a double-blind design, dosing rules, and thrombotic risk safeguards.
FibroGen will test roxadustat in 200 LR-MDS patients with an 8-week or 16-week red cell independence endpoint. The company expects to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025, aiming to advance roxadustat as an oral treatment for anemia in transfusion-dependent patients.
Read Announcement
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