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TDT067
TDT067 is a S1P1 receptor modulator Small molecule drug developed by Celtic Pharma Development Services. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis.
TDT067 is a small molecule that targets the S1P1 receptor.
TDT067 is a small molecule that inhibits the enzyme squalene monooxygenase. It is being studied in clinical trials for various conditions, including neoplasms, drug-induced liver injury, and mycoses, among others.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | TDT067 |
|---|---|
| Sponsor | Celtic Pharma Development Services |
| Drug class | S1P1 receptor modulator |
| Target | S1P1 |
| Modality | Small molecule |
| Therapeutic area | Autoimmune diseases |
| Phase | Phase 3 |
Mechanism of action
TDT067 acts as a selective S1P1 receptor modulator, which is involved in the regulation of lymphocyte trafficking and immune responses. By modulating the S1P1 receptor, TDT067 aims to reduce inflammation and autoimmune responses.
Approved indications
- Relapsing forms of multiple sclerosis
Common side effects
- Headache
- Nausea
- Fatigue
Key clinical trials
- A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails (PHASE2)
- Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) (PHASE2)
- Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children. (NA)
- Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris (NA)
- Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine (NA)
- Terbinafine Hydrochloride for the Treatment of Otomycosis (NA)
- Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
- From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients (PHASE1, 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:
- TDT067 CI brief — competitive landscape report
- TDT067 updates RSS · CI watch RSS
- Celtic Pharma Development Services portfolio CI
Frequently asked questions about TDT067
What is TDT067?
How does TDT067 work?
What is TDT067 used for?
Who makes TDT067?
What drug class is TDT067 in?
What development phase is TDT067 in?
What are the side effects of TDT067?
What does TDT067 target?
Related
- Drug class: All S1P1 receptor modulator drugs
- Target: All drugs targeting S1P1
- Manufacturer: Celtic Pharma Development Services — full pipeline
- Therapeutic area: All drugs in Autoimmune diseases
- Indication: Drugs for Relapsing forms of multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing