Last reviewed · How we verify
KLH Day 29
KLH Day 29 is a Biologic drug developed by Providence Health & Services. It is currently in Phase 1 development. Also known as: Immucothel..
KLH Day 29 refers to a treatment involving anti-OX40 monoclonal antibody, which was studied in a Phase 1 trial for patients with advanced cancer. This trial, identified as NCT01644968, was conducted by Providence Health & Services to evaluate the safety and efficacy of anti-OX40 in this patient population.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | KLH Day 29 |
|---|---|
| Also known as | Immucothel. |
| Sponsor | Providence Health & Services |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer (PHASE1)
- Characterisation of T-cell Response to Keyhole Limpet Hemocyanin (KLH) and Tuberculin Purified Protein Derivative (PPD) (PHASE1)
- A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax) (PHASE4)
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:
- KLH Day 29 CI brief — competitive landscape report
- KLH Day 29 updates RSS · CI watch RSS
- Providence Health & Services portfolio CI
Frequently asked questions about KLH Day 29
What is KLH Day 29?
Who makes KLH Day 29?
Is KLH Day 29 also known as anything else?
What development phase is KLH Day 29 in?
Related
- Manufacturer: Providence Health & Services — full pipeline
- Also known as: Immucothel.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing