Elevar Therapeutics

Latest, September 23, 2026FDA approved Lyrfigtu (lirafugratinib) on September 23, 2026 for previously treated FGFR2 fusion cholangiocarcinoma, Elevar's first approved drug. The FDA declined to approve rivoceranib with camrelizumab for liver cancer in July 2026, and Elevar plans to resubmit. Lyrfigtu drug page with FDA sources

Elevar Therapeutics works on 1 rare disease tracked on Trial Friend, including Cholangiocarcinoma, with 1 recruiting clinical trial and 1 FDA-approved rare disease drug.

Elevar Therapeutics is a Fort Lee, New Jersey biopharmaceutical company (formerly LSK BioPharma) and a majority-owned subsidiary of South Korea's HLB Group. Its lead programs are lirafugratinib, a selective FGFR2 inhibitor licensed globally from Relay Therapeutics in December 2024 for FGFR2 fusion-driven cholangiocarcinoma, approved by the FDA as Lyrfigtu on September 23, 2026, and rivoceranib, a VEGFR-2 inhibitor developed with camrelizumab for first-line hepatocellular carcinoma. The FDA declined to approve that combination in July 2026 because of problems found at a manufacturing site inspection, and Elevar says it is preparing to resubmit.

Type
Rare Disease Specialist
Parent
HLB Group
Headquarters
Fort Lee, United States
1
Active Rare Disease Trials
1
Approved Rare Disease Drugs
1
Rare Diseases in Portfolio

Elevar Therapeutics Drug Pipeline

Elevar Therapeutics has 1 active clinical trial across 1 development stage, with 1 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.

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1
Phase 21 trial
FGFR2 Gene Fusion/Rearrangement+1 more
Recruiting

Elevar Therapeutics Clinical Trials (1)

Active and recruiting clinical trials sponsored by Elevar Therapeutics, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

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RECRUITINGPHASE2Recently updatedNCT07359820

A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

Intervention: Lirafugratinib

FGFR2 Gene Fusion/RearrangementOther Solid Tumors, Adult

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor. * Visit the clinic as instructed for checkups and tests. * Keep a diary recording each time a dose of lirafugratinib is taken.

Ages 18 Years+19 locations
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Elevar Therapeutics FDA-Approved Drugs (1)

Medications developed or marketed by Elevar Therapeutics that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
LIRAFUGRATINIBLYRFIGTUSep 23, 2026

Elevar Therapeutics Trial Locations

Elevar Therapeutics clinical trials are running at 19 sites in 5 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
8▼
France
4▼
Spain
3▼
South Korea
2▼
United Kingdom
2▼

Rare Disease Focus Areas (1)

Diseases targeted by Elevar Therapeutics's clinical trial and drug development programs

Patient Resources

Organizations and resources related to Elevar Therapeutics's rare disease focus areas

Frequently Asked Questions About Elevar Therapeutics

Common questions about Elevar Therapeutics's rare disease programs, clinical trials, and treatments.