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8-methoxypsoralen
8-methoxypsoralen is a Psoralen photosensitizer Small molecule drug developed by Medical University of Graz. It is currently in Phase 3 development for Cutaneous T-cell lymphoma (mycosis fungoides), Psoriasis, Vitiligo. Also known as: Oxsoralen®; Gerot Pharmazeutika GmbH, Vienna, Austria.
8-methoxypsoralen is a photoactive compound that intercalates into DNA and forms covalent crosslinks upon UVA exposure, triggering apoptosis in abnormal cells.
8-methoxypsoralen is a photoactive compound that intercalates into DNA and forms covalent crosslinks upon UVA exposure, triggering apoptosis in abnormal cells. Used for Cutaneous T-cell lymphoma (mycosis fungoides), Psoriasis, Vitiligo.
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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 | 8-methoxypsoralen |
|---|---|
| Also known as | Oxsoralen®; Gerot Pharmazeutika GmbH, Vienna, Austria |
| Sponsor | Medical University of Graz |
| Drug class | Psoralen photosensitizer |
| Target | DNA (non-specific intercalating agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Dermatology |
| Phase | Phase 3 |
Mechanism of action
8-methoxypsoralen (8-MOP) is a naturally occurring furocoumarin that belongs to the psoralen class of photosensitizing agents. When activated by long-wave ultraviolet A (UVA) radiation, it intercalates into DNA and forms thymine-psoralen photoadducts, creating interstrand crosslinks that damage DNA and induce cell death. This mechanism is particularly effective against rapidly dividing cells, making it useful in treating cutaneous T-cell lymphomas and other skin disorders.
Approved indications
- Cutaneous T-cell lymphoma (mycosis fungoides)
- Psoriasis
- Vitiligo
Common side effects
- Phototoxicity (erythema, blistering)
- Nausea
- Pruritus
- Increased risk of skin cancer with long-term use
Key clinical trials
- Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation. (NA)
- EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (PHASE2)
- Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis (NA)
- Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
- Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts (PHASE3)
- A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (PHASE3)
- Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis (PHASE2)
- Extracorporeal Photopheresis for Acute Graft Versus Host Disease (PHASE2, PHASE3)
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:
- 8-methoxypsoralen CI brief — competitive landscape report
- 8-methoxypsoralen updates RSS · CI watch RSS
- Medical University of Graz portfolio CI
Frequently asked questions about 8-methoxypsoralen
What is 8-methoxypsoralen?
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What is 8-methoxypsoralen used for?
Who makes 8-methoxypsoralen?
Is 8-methoxypsoralen also known as anything else?
What drug class is 8-methoxypsoralen in?
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What does 8-methoxypsoralen target?
Related
- Drug class: All Psoralen photosensitizer drugs
- Target: All drugs targeting DNA (non-specific intercalating agent)
- Manufacturer: Medical University of Graz — full pipeline
- Therapeutic area: All drugs in Oncology; Dermatology
- Indication: Drugs for Cutaneous T-cell lymphoma (mycosis fungoides)
- Indication: Drugs for Psoriasis
- Indication: Drugs for Vitiligo
- Also known as: Oxsoralen®; Gerot Pharmazeutika GmbH, Vienna, Austria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing