Last reviewed 2026-04-22 · How we verify

C) primary immunizations with Ixiaro

Helsinki University Central Hospital · Phase 3 active Biologic

C) primary immunizations with Ixiaro is a Inactivated viral vaccine Biologic drug developed by Helsinki University Central Hospital. It is currently in Phase 3 development for Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas. Also known as: Ixiaro.

Ixiaro is an inactivated Japanese encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against Japanese encephalitis virus.

Ixiaro is an inactivated Japanese encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against Japanese encephalitis virus. Used for Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	C) primary immunizations with Ixiaro
Also known as	Ixiaro
Sponsor	Helsinki University Central Hospital
Drug class	Inactivated viral vaccine
Target	Japanese encephalitis virus envelope and non-structural proteins
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

Ixiaro contains inactivated Japanese encephalitis virus derived from the SA 14-14-2 strain, which primes both humoral and cell-mediated immune responses. Upon vaccination, the immune system recognizes viral antigens and generates neutralizing antibodies and T-cell responses that protect against infection with wild-type Japanese encephalitis virus. This provides protection against Japanese encephalitis, a potentially fatal neuroinflammatory disease transmitted by Culex mosquitoes in Asia and the Western Pacific.

Approved indications

Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas

Common side effects

Injection site pain or erythema
Myalgia
Headache
Fever
Fatigue

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

C) primary immunizations with Ixiaro CI brief — competitive landscape report
C) primary immunizations with Ixiaro updates RSS · CI watch RSS
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Frequently asked questions about C) primary immunizations with Ixiaro

What is C) primary immunizations with Ixiaro?

C) primary immunizations with Ixiaro is a Inactivated viral vaccine drug developed by Helsinki University Central Hospital, indicated for Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas.

How does C) primary immunizations with Ixiaro work?

Ixiaro is an inactivated Japanese encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against Japanese encephalitis virus.

What is C) primary immunizations with Ixiaro used for?

C) primary immunizations with Ixiaro is indicated for Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas.

Who makes C) primary immunizations with Ixiaro?

C) primary immunizations with Ixiaro is developed by Helsinki University Central Hospital (see full Helsinki University Central Hospital pipeline at /company/helsinki-university-central-hospital).

Is C) primary immunizations with Ixiaro also known as anything else?

C) primary immunizations with Ixiaro is also known as Ixiaro.

What drug class is C) primary immunizations with Ixiaro in?

C) primary immunizations with Ixiaro belongs to the Inactivated viral vaccine class. See all Inactivated viral vaccine drugs at /class/inactivated-viral-vaccine.

What development phase is C) primary immunizations with Ixiaro in?

C) primary immunizations with Ixiaro is in Phase 3.

What are the side effects of C) primary immunizations with Ixiaro?

Common side effects of C) primary immunizations with Ixiaro include Injection site pain or erythema, Myalgia, Headache, Fever, Fatigue.

What does C) primary immunizations with Ixiaro target?

C) primary immunizations with Ixiaro targets Japanese encephalitis virus envelope and non-structural proteins and is a Inactivated viral vaccine.

Drug class: All Inactivated viral vaccine drugs
Target: All drugs targeting Japanese encephalitis virus envelope and non-structural proteins
Manufacturer: Helsinki University Central Hospital — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Primary immunization against Japanese encephalitis in endemic regions and travelers to endemic areas
Also known as: Ixiaro

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