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Rebif New Formulation Titrated
Rebif New Formulation Titrated is a Interferon Small molecule drug developed by EMD Serono. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis.
Rebif New Formulation Titrated is an interferon beta-1a formulation used to treat multiple sclerosis.
Rebif New Formulation Titrated is used to treat relapsing forms of multiple sclerosis. It is a treatment option for patients with relapsing multiple sclerosis, as indicated by ClinicalTrials.gov.
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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 Titrated |
|---|---|
| Sponsor | EMD Serono |
| Drug class | Interferon |
| Target | IFNAR |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
It works by stimulating the body's immune system to reduce inflammation in the central nervous system, thereby slowing the progression of the disease. Interferon beta-1a has been shown to decrease the frequency of relapses and slow the progression of disability in patients with multiple sclerosis.
Approved indications
- Relapsing forms of multiple sclerosis
Common side effects
- Flu-like symptoms
- Injection site reactions
- Fatigue
- Headache
- Depression
Key clinical trials
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 Titrated CI brief — competitive landscape report
- Rebif New Formulation Titrated updates RSS · CI watch RSS
- EMD Serono portfolio CI
Frequently asked questions about Rebif New Formulation Titrated
What is Rebif New Formulation Titrated?
How does Rebif New Formulation Titrated work?
What is Rebif New Formulation Titrated used for?
Who makes Rebif New Formulation Titrated?
What drug class is Rebif New Formulation Titrated in?
What development phase is Rebif New Formulation Titrated in?
What are the side effects of Rebif New Formulation Titrated?
What does Rebif New Formulation Titrated target?
Related
- Drug class: All Interferon drugs
- Target: All drugs targeting IFNAR
- Manufacturer: EMD Serono — 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