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177Lu-PSMA-I&T
177Lu-PSMA-I&T is a Radioligand therapy Small molecule drug developed by Weill Medical College of Cornell University. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression. Also known as: 177Lu-PNT2002.
177Lu-PSMA-I&T is a radioligand therapy that binds to prostate-specific membrane antigen (PSMA) on cancer cells and delivers targeted radiation to kill them.
177Lu-PSMA-I&T is being studied as a treatment for various types of cancer, including prostate cancer, castration-resistant prostate cancer, and high-grade glioma. It is a radiometabolic therapy that targets PSMA-positive tumors, as indicated by a positive PSMA PET/CT scan.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | 177Lu-PSMA-I&T |
|---|---|
| Also known as | 177Lu-PNT2002 |
| Sponsor | Weill Medical College of Cornell University |
| Drug class | Radioligand therapy |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This drug combines a lutetium-177 radioisotope with a PSMA-targeting ligand that specifically recognizes and binds to PSMA expressed on prostate cancer cells. Once bound, the radioisotope delivers localized beta radiation directly to PSMA-positive tumors while sparing healthy tissue, enabling targeted internal radiation therapy for metastatic castration-resistant prostate cancer.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
Common side effects
- Hematologic toxicity (anemia, thrombocytopenia, leukopenia)
- Xerostomia (dry mouth)
- Nausea
- Fatigue
- Kidney toxicity
Key clinical trials
- Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients (PHASE2)
- Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (PHASE3)
- Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma (PHASE1)
- Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours: (PHASE2)
- Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST) (PHASE2)
- PSMA Therapy and Immunotherapy in Kidney Cancer (PHASE1, PHASE2)
- 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer (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:
- 177Lu-PSMA-I&T CI brief — competitive landscape report
- 177Lu-PSMA-I&T updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about 177Lu-PSMA-I&T
What is 177Lu-PSMA-I&T?
How does 177Lu-PSMA-I&T work?
What is 177Lu-PSMA-I&T used for?
Who makes 177Lu-PSMA-I&T?
Is 177Lu-PSMA-I&T also known as anything else?
What drug class is 177Lu-PSMA-I&T in?
What development phase is 177Lu-PSMA-I&T in?
What are the side effects of 177Lu-PSMA-I&T?
What does 177Lu-PSMA-I&T target?
Related
- Drug class: All Radioligand therapy drugs
- Target: All drugs targeting PSMA (prostate-specific membrane antigen)
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
- Also known as: 177Lu-PNT2002
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing