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I-131-1095

Progenics Pharmaceuticals, Inc. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 40/100

I-131-1095 is a Radiopharmaceutical Small molecule drug developed by Progenics Pharmaceuticals, Inc.. It is currently in Phase 2 development. Also known as: 131 I-PSMA-1095, 131I-LNTH-1095.

I-131-1095 binds to prostate-specific membrane antigen (PSMA) and delivers targeted radiation to PSMA-expressing cancer cells.

I-131-1095 is a radioligand being studied in a Phase 2 clinical trial for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that has progressed during abiraterone treatment. In this trial, I-131-1095 is being compared to the medication Enzalutamide for efficacy and safety.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameI-131-1095
Also known as131 I-PSMA-1095, 131I-LNTH-1095
SponsorProgenics Pharmaceuticals, Inc.
Drug classRadiopharmaceutical
ModalitySmall molecule
PhasePhase 2

Mechanism of action

I-131-1095 is a radiolabeled small molecule that selectively binds to PSMA, a cell surface protein highly expressed in prostate cancer cells. Upon binding, the iodine-131 radioisotope delivers beta radiation directly to tumor cells, enabling both imaging and targeted radiotherapy of PSMA-positive lesions.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about I-131-1095

What is I-131-1095?

I-131-1095 is a Radiopharmaceutical drug developed by Progenics Pharmaceuticals, Inc..

How does I-131-1095 work?

I-131-1095 binds to prostate-specific membrane antigen (PSMA) and delivers targeted radiation to PSMA-expressing cancer cells.

Who makes I-131-1095?

I-131-1095 is developed by Progenics Pharmaceuticals, Inc. (see full Progenics Pharmaceuticals, Inc. pipeline at /company/progenics-pharmaceuticals-inc).

Is I-131-1095 also known as anything else?

I-131-1095 is also known as 131 I-PSMA-1095, 131I-LNTH-1095.

What drug class is I-131-1095 in?

I-131-1095 belongs to the Radiopharmaceutical class. See all Radiopharmaceutical drugs at /class/radiopharmaceutical.

What development phase is I-131-1095 in?

I-131-1095 is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing