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Everolimus (Certican)
Everolimus (Certican) is a mTOR inhibitor Small molecule drug developed by Novartis. It is currently in Phase 3 development for Prevention of organ rejection in heart transplant recipients, Prevention of organ rejection in kidney transplant recipients, Advanced renal cell carcinoma. Also known as: Certican.
Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that regulates cell growth and proliferation.
Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that regulates cell growth and proliferation. Used for Prevention of organ rejection in heart transplant recipients, Prevention of organ rejection in kidney transplant recipients, Advanced renal 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. -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Everolimus (Certican) |
|---|---|
| Also known as | Certican |
| Sponsor | Novartis |
| Drug class | mTOR inhibitor |
| Target | mTOR (mammalian target of rapamycin) |
| Modality | Small molecule |
| Therapeutic area | Immunology, Oncology |
| Phase | Phase 3 |
Mechanism of action
Everolimus is an mTOR inhibitor that suppresses cell cycle progression and reduces angiogenesis by blocking mTOR signaling. It is used primarily as an immunosuppressant in transplantation to prevent organ rejection, and also has anti-tumor activity in certain cancers by inhibiting proliferation of cancer cells dependent on mTOR pathway activation.
Approved indications
- Prevention of organ rejection in heart transplant recipients
- Prevention of organ rejection in kidney transplant recipients
- Advanced renal cell carcinoma
- Pancreatic neuroendocrine tumors
- Breast cancer (hormone receptor-positive, HER2-negative)
Common side effects
- Infections (bacterial, viral, fungal)
- Stomatitis/mouth ulcers
- Anemia
- Thrombocytopenia
- Hyperlipidemia
- Hyperglycemia
- Pneumonitis
- Diarrhea
Key clinical trials
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors (PHASE2)
- Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021) (PHASE1)
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (PHASE3)
- Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer (PHASE2)
- Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma (NA)
- Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer (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:
- Everolimus (Certican) CI brief — competitive landscape report
- Everolimus (Certican) updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Everolimus (Certican)
What is Everolimus (Certican)?
How does Everolimus (Certican) work?
What is Everolimus (Certican) used for?
Who makes Everolimus (Certican)?
Is Everolimus (Certican) also known as anything else?
What drug class is Everolimus (Certican) in?
What development phase is Everolimus (Certican) in?
What are the side effects of Everolimus (Certican)?
What does Everolimus (Certican) target?
Related
- Drug class: All mTOR inhibitor drugs
- Target: All drugs targeting mTOR (mammalian target of rapamycin)
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Immunology, Oncology
- Indication: Drugs for Prevention of organ rejection in heart transplant recipients
- Indication: Drugs for Prevention of organ rejection in kidney transplant recipients
- Indication: Drugs for Advanced renal cell carcinoma
- Also known as: Certican
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing