Last reviewed 2026-05-23 · How we verify

Theravac

Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 1 active Biologic ✓ Verified May 2026

Theravac is a Biologic drug developed by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. It is currently in Phase 1 development.

Theravac is a treatment being studied in a clinical trial for advanced metastatic melanoma. The trial, NCT01331915, is a Phase I/II study to assess the safety and toxicity of Theravac in patients with this condition.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Theravac
Sponsor	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Modality	Biologic
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma 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:

Theravac CI brief — competitive landscape report
Theravac updates RSS · CI watch RSS
Cliniques universitaires Saint-Luc- Université Catholique de Louvain portfolio CI

Frequently asked questions about Theravac

What is Theravac?

Theravac is a Biologic drug developed by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Who makes Theravac?

Theravac is developed by Cliniques universitaires Saint-Luc- Université Catholique de Louvain (see full Cliniques universitaires Saint-Luc- Université Catholique de Louvain pipeline at /company/cliniques-universitaires-saint-luc-universit-catholique-de-louvain).

What development phase is Theravac in?

Theravac is in Phase 1.

Manufacturer: Cliniques universitaires Saint-Luc- Université Catholique de Louvain — full pipeline
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing