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INCLACUMAB
INCLACUMAB is a drug. It is currently in Phase 3 development.
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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).
| 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 | INCLACUMAB |
|---|---|
| Modality | Monoclonal antibody |
| Phase | Phase 3 |
Approved indications
Common side effects
- Sickle cell anaemia with crisis
- Malaria
- Headache
- Arthralgia
- Back pain
- Nasopharyngitis
- Upper respiratory tract infection
- Nausea
- Pyrexia
- Pain in extremity
- Pain
- Anaemia
Key clinical trials
- A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease (PHASE3)
- A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises (PHASE3)
- A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises (PHASE3)
- A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention (PHASE2)
- A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD). (PHASE1)
- A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery (PHASE2)
- A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers (PHASE1)
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:
- INCLACUMAB CI brief — competitive landscape report
- INCLACUMAB updates RSS · CI watch RSS
Frequently asked questions about INCLACUMAB
What is INCLACUMAB?
What development phase is INCLACUMAB in?
What are the side effects of INCLACUMAB?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing