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Adjuvant IM Therapy
Adjuvant IM Therapy is a Small molecule drug developed by Ultragenyx Pharmaceutical Inc. It is currently in Phase 2 development.
Adjuvant IM Therapy, also known as Incomplete Freund's Adjuvant, is a treatment modality used in various clinical trials, including those for Genital Herpes Simplex Type 2, Prostate Adenocarcinoma, and Stage I-Stage IIB Prostate Cancer. The exact mechanism of Adjuvant IM Therapy is unknown, but it is administered via intramuscular injection as part of formulations such as GEN-003 and Matrix-M2.
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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).
| 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 name | Adjuvant IM Therapy |
|---|---|
| Sponsor | Ultragenyx Pharmaceutical Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (PHASE2, PHASE3)
- Phase I/II/III Gene Transfer Clinical Trial of scAAV9.U1a.hSGSH (PHASE2, PHASE3)
- A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) (PHASE3)
- A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) (PHASE3)
- Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (PHASE2)
- A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (PHASE3)
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (PHASE1)
- Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine (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:
- Adjuvant IM Therapy CI brief — competitive landscape report
- Adjuvant IM Therapy updates RSS · CI watch RSS
- Ultragenyx Pharmaceutical Inc portfolio CI
Frequently asked questions about Adjuvant IM Therapy
What is Adjuvant IM Therapy?
Who makes Adjuvant IM Therapy?
What development phase is Adjuvant IM Therapy in?
Related
- Manufacturer: Ultragenyx Pharmaceutical Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing