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Atacicept: with loading dose
Atacicept: with loading dose is a B cell depleting agent Small molecule drug developed by EMD Serono. It is currently in Phase 2 development for Rheumatoid arthritis.
CD28/B7 costimulation blockade
CD28/B7 costimulation blockade Used for Rheumatoid arthritis.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Atacicept: with loading dose |
|---|---|
| Sponsor | EMD Serono |
| Drug class | B cell depleting agent |
| Target | CD28/B7 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Atacicept is a recombinant protein that blocks the interaction between CD28 and B7 molecules, thereby inhibiting T-cell activation and proliferation.
Approved indications
- Rheumatoid arthritis
Common side effects
- Injection site reaction
- Headache
- Fatigue
Key clinical trials
- Atacicept in Multiple Sclerosis Extension Study, Phase II (PHASE2)
- A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) (PHASE2)
- Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) (PHASE2, PHASE3)
- Atacicept in Subjects With Optic Neuritis (PHASE2)
- Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II) (PHASE2)
- A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I) (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:
- Atacicept: with loading dose CI brief — competitive landscape report
- Atacicept: with loading dose updates RSS · CI watch RSS
- EMD Serono portfolio CI
Frequently asked questions about Atacicept: with loading dose
What is Atacicept: with loading dose?
How does Atacicept: with loading dose work?
What is Atacicept: with loading dose used for?
Who makes Atacicept: with loading dose?
What drug class is Atacicept: with loading dose in?
What development phase is Atacicept: with loading dose in?
What are the side effects of Atacicept: with loading dose?
What does Atacicept: with loading dose target?
Related
- Drug class: All B cell depleting agent drugs
- Target: All drugs targeting CD28/B7
- Manufacturer: EMD Serono — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing