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ABT-414
ABT-414 is a Antibody-drug conjugate (ADC) Small molecule drug developed by AbbVie. It is currently in Phase 2 development. Also known as: Depatuxizumab, Mafodotin, Depatuxizumab Mafodotin.
ABT-414 is an antibody-drug conjugate that binds to EGFR and delivers a cytotoxic payload directly to cancer cells.
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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). -
Big-pharma sponsor
+3.0pp
AbbVie 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 | ABT-414 |
|---|---|
| Also known as | Depatuxizumab, Mafodotin, Depatuxizumab Mafodotin |
| Sponsor | AbbVie |
| Drug class | Antibody-drug conjugate (ADC) |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
ABT-414 consists of an anti-EGFR monoclonal antibody linked to monomethyl auristatin F (MMAF), a microtubule-disrupting agent. Upon binding to EGFR on tumor cells, the conjugate is internalized and the cytotoxic payload is released, leading to cell death. This targeted approach aims to maximize tumor cell killing while minimizing systemic toxicity.
Approved indications
Common side effects
Key clinical trials
- A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (PHASE3)
- UNITE Study: Understanding New Interventions With GBM ThErapy (PHASE3)
- Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (PHASE1, PHASE2)
- Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas (PHASE2)
- Expanded Access to ABT-414
- A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor (PHASE1)
- Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme (PHASE1)
- A Study of ABT-414 in Subjects With Solid Tumors (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:
- ABT-414 CI brief — competitive landscape report
- ABT-414 updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about ABT-414
What is ABT-414?
How does ABT-414 work?
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Is ABT-414 also known as anything else?
What drug class is ABT-414 in?
What development phase is ABT-414 in?
Related
- Drug class: All Antibody-drug conjugate (ADC) drugs
- Manufacturer: AbbVie — full pipeline
- Also known as: Depatuxizumab, Mafodotin, Depatuxizumab Mafodotin