Last reviewed · How we verify
OTL38 for Injection
OTL38 for Injection is a Antibody-drug conjugate (ADC) Small molecule drug developed by On Target Laboratories, LLC. It is currently in Phase 3 development for Ovarian cancer (folate receptor alpha positive), Non-small cell lung cancer (folate receptor alpha positive), Triple-negative breast cancer (folate receptor alpha positive). Also known as: OTL38, CYTALUX™ (pafolacianine) injection.
OTL38 is a folate receptor alpha-targeted immunoconjugate that delivers a cytotoxic payload to cancer cells expressing folate receptor alpha.
OTL38 for Injection is being studied in a Phase 2 clinical trial for the intraoperative imaging of folate receptor positive lung nodules in patients with Lung Neoplasms, Lung Cancer, Ovarian Cancer, Neoplasms, and Pituitary Neoplasms. The study involves a single dose of OTL38 for Injection and near infrared camera imaging system, in addition to endoscopic or thoracic surgery.
-
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 | OTL38 for Injection |
|---|---|
| Also known as | OTL38, CYTALUX™ (pafolacianine) injection |
| Sponsor | On Target Laboratories, LLC |
| Drug class | Antibody-drug conjugate (ADC) |
| Target | Folate receptor alpha (FRA) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
OTL38 consists of a humanized monoclonal antibody against folate receptor alpha conjugated to a cytotoxic agent. The antibody binds to folate receptor alpha, which is overexpressed on many cancer cells, allowing selective delivery of the cytotoxic payload to tumor cells while sparing normal tissues. This targeted approach aims to improve efficacy and reduce systemic toxicity compared to conventional chemotherapy.
Approved indications
- Ovarian cancer (folate receptor alpha positive)
- Non-small cell lung cancer (folate receptor alpha positive)
- Triple-negative breast cancer (folate receptor alpha positive)
Common side effects
- Nausea
- Fatigue
- Anemia
- Thrombocytopenia
- Peripheral neuropathy
Key clinical trials
- Safety and Feasibility of Intraoperative Visualization With Cytalux in Children (PHASE1)
- OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules (PHASE2)
- ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting (PHASE3)
- OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer (PHASE1)
- Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer (PHASE2)
- OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer (PHASE3)
- Intraoperative Imaging of Pituitary Adenomas by OTL (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:
- OTL38 for Injection CI brief — competitive landscape report
- OTL38 for Injection updates RSS · CI watch RSS
- On Target Laboratories, LLC portfolio CI
Frequently asked questions about OTL38 for Injection
What is OTL38 for Injection?
How does OTL38 for Injection work?
What is OTL38 for Injection used for?
Who makes OTL38 for Injection?
Is OTL38 for Injection also known as anything else?
What drug class is OTL38 for Injection in?
What development phase is OTL38 for Injection in?
What are the side effects of OTL38 for Injection?
What does OTL38 for Injection target?
Related
- Drug class: All Antibody-drug conjugate (ADC) drugs
- Target: All drugs targeting Folate receptor alpha (FRA)
- Manufacturer: On Target Laboratories, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Ovarian cancer (folate receptor alpha positive)
- Indication: Drugs for Non-small cell lung cancer (folate receptor alpha positive)
- Indication: Drugs for Triple-negative breast cancer (folate receptor alpha positive)
- Also known as: OTL38, CYTALUX™ (pafolacianine) injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing