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Placebo Lonafarnib
Placebo Lonafarnib is a Farnesyltransferase inhibitor Small molecule drug developed by Eiger BioPharmaceuticals. It is currently in Phase 3 development for KRAS-mutant pancreatic cancer, HRAS-mutant head and neck squamous cell carcinoma.
Lonafarnib inhibits farnesyltransferase, blocking the post-translational modification of proteins involved in cell proliferation and survival.
Lonafarnib inhibits farnesyltransferase, blocking the post-translational modification of proteins involved in cell proliferation and survival. Used for KRAS-mutant pancreatic cancer, HRAS-mutant head and neck squamous cell carcinoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Placebo Lonafarnib |
|---|---|
| Sponsor | Eiger BioPharmaceuticals |
| Drug class | Farnesyltransferase inhibitor |
| Target | Farnesyltransferase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Farnesyltransferase inhibitors prevent the attachment of farnesyl groups to proteins like RAS and KRAS, which are frequently mutated in cancers and play critical roles in oncogenic signaling. By blocking this modification, lonafarnib disrupts the membrane localization and activation of these proteins, thereby suppressing tumor cell growth and survival pathways.
Approved indications
- KRAS-mutant pancreatic cancer
- HRAS-mutant head and neck squamous cell carcinoma
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Abdominal pain
Key clinical trials
- Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a (PHASE3)
- Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir (PHASE2)
- Lonafarnib for Chronic Hepatitis D (PHASE2)
- Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED) (PHASE3)
- Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED) (PHASE3)
- Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo Lonafarnib CI brief — competitive landscape report
- Placebo Lonafarnib updates RSS · CI watch RSS
- Eiger BioPharmaceuticals portfolio CI
Frequently asked questions about Placebo Lonafarnib
What is Placebo Lonafarnib?
How does Placebo Lonafarnib work?
What is Placebo Lonafarnib used for?
Who makes Placebo Lonafarnib?
What drug class is Placebo Lonafarnib in?
What development phase is Placebo Lonafarnib in?
What are the side effects of Placebo Lonafarnib?
What does Placebo Lonafarnib target?
Related
- Drug class: All Farnesyltransferase inhibitor drugs
- Target: All drugs targeting Farnesyltransferase
- Manufacturer: Eiger BioPharmaceuticals — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for KRAS-mutant pancreatic cancer
- Indication: Drugs for HRAS-mutant head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing