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NGR-hTNF
NGR-hTNF is a Small molecule drug developed by AGC Biologics S.p.A.. It is currently in Phase 2 development. Also known as: iv q3W escalating dose up 1.6 mcg/sqm.
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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).
| 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 | NGR-hTNF |
|---|---|
| Also known as | iv q3W escalating dose up 1.6 mcg/sqm |
| Sponsor | AGC Biologics S.p.A. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor (PHASE2)
- A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors (PHASE1)
- Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors (PHASE1)
- Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma (PHASE2)
- NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed (PHASE3)
- Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC) (PHASE2)
- Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma (PHASE2)
- NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018) (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:
- NGR-hTNF CI brief — competitive landscape report
- NGR-hTNF updates RSS · CI watch RSS
- AGC Biologics S.p.A. portfolio CI
Frequently asked questions about NGR-hTNF
What is NGR-hTNF?
Who makes NGR-hTNF?
Is NGR-hTNF also known as anything else?
What development phase is NGR-hTNF in?
Related
- Manufacturer: AGC Biologics S.p.A. — full pipeline
- Also known as: iv q3W escalating dose up 1.6 mcg/sqm
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing