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Rebif® new formulation (RNF)
Rebif® new formulation (RNF) is a Interferon Small molecule drug developed by EMD Serono Research & Development Institute, Inc.. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis.
Rebif new formulation (RNF) is an interferon beta-1a used to treat multiple sclerosis.
Rebif's new formulation (RNF) is a human interferon beta-1a used to treat Relapsing Remitting Multiple Sclerosis (RRMS) and Multiple Sclerosis. The new formulation is also free from human serum albumin (HSA) and fetal bovine serum (FBS).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Rebif® new formulation (RNF) |
|---|---|
| Sponsor | EMD Serono Research & Development Institute, Inc. |
| Drug class | Interferon |
| Target | IFNAR |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
It works by reducing inflammation in the central nervous system, which helps to slow the progression of the disease. Interferon beta-1a is a protein that helps to regulate the immune system and reduce the severity of MS symptoms. By reducing inflammation, Rebif RNF can help to slow the progression of disability and reduce the frequency of relapses.
Approved indications
- Relapsing forms of multiple sclerosis
Common side effects
- Flu-like symptoms
- Injection site reactions
- Fatigue
- Headache
- Nausea
Key clinical trials
- Oral Cladribine in Early Multiple Sclerosis (MS) (PHASE3)
- A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) (PHASE2)
- Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) (PHASE3)
- Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (PHASE3)
- A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis (PHASE3)
- 12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis. (PHASE3)
- RNF and Betaseron® Tolerability Study (PHASE3)
- Rebif New Formulation (RNF) Quality of Life (QOL) Study (PHASE3)
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:
- Rebif® new formulation (RNF) CI brief — competitive landscape report
- Rebif® new formulation (RNF) updates RSS · CI watch RSS
- EMD Serono Research & Development Institute, Inc. portfolio CI
Frequently asked questions about Rebif® new formulation (RNF)
What is Rebif® new formulation (RNF)?
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What is Rebif® new formulation (RNF) used for?
Who makes Rebif® new formulation (RNF)?
What drug class is Rebif® new formulation (RNF) in?
What development phase is Rebif® new formulation (RNF) in?
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Related
- Drug class: All Interferon drugs
- Target: All drugs targeting IFNAR
- Manufacturer: EMD Serono Research & Development Institute, Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Relapsing forms of multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing