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I-DXd
I-DXd is a CD22-targeting antibody-drug conjugate Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 2 development for Relapsed or refractory B-cell non-Hodgkin lymphoma. Also known as: Ifinatamab Deruxtecan, DS-7300a, MK-2400, Ifinatamab deruxtecan.
Targeting CD22 with antibody-drug conjugate
Targeting CD22 with antibody-drug conjugate Used for Relapsed or refractory B-cell non-Hodgkin lymphoma.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC 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 | 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 | I-DXd |
|---|---|
| Also known as | Ifinatamab Deruxtecan, DS-7300a, MK-2400, Ifinatamab deruxtecan |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | CD22-targeting antibody-drug conjugate |
| Target | CD22 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
I-DXd is an antibody-drug conjugate that targets CD22, a protein expressed on the surface of B-cell lymphoblasts. This targeted therapy delivers a cytotoxic payload to cancer cells, inducing cell death.
Approved indications
- Relapsed or refractory B-cell non-Hodgkin lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Nausea
Key clinical trials
- A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) (PHASE3)
- Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer (PHASE1)
- Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer (PHASE1)
- Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (PHASE1)
- Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation (PHASE1, PHASE2)
- A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (PHASE1, PHASE2)
- A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (PHASE1, PHASE2)
- A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01) (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:
- I-DXd CI brief — competitive landscape report
- I-DXd updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about I-DXd
What is I-DXd?
How does I-DXd work?
What is I-DXd used for?
Who makes I-DXd?
Is I-DXd also known as anything else?
What drug class is I-DXd in?
What development phase is I-DXd in?
What are the side effects of I-DXd?
What does I-DXd target?
Related
- Drug class: All CD22-targeting antibody-drug conjugate drugs
- Target: All drugs targeting CD22
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory B-cell non-Hodgkin lymphoma
- Also known as: Ifinatamab Deruxtecan, DS-7300a, MK-2400, Ifinatamab deruxtecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing