Last reviewed 2026-05-18 · How we verify

Allergovac himenoptera

Roxall Medicina España S.A · Phase 2 active Biologic Quality 55/100

Allergovac himenoptera is a Allergen immunotherapy Biologic drug developed by Roxall Medicina España S.A. It is currently in Phase 2 development.

Allergen immunotherapy that induces immune tolerance to hymenoptera venom through gradual exposure to increasing doses of venom allergens.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Allergovac himenoptera
Sponsor	Roxall Medicina España S.A
Drug class	Allergen immunotherapy
Modality	Biologic
Phase	Phase 2

Mechanism of action

The product works by administering controlled doses of hymenoptera venom allergens to gradually desensitize the immune system. This process shifts the immune response from IgE-mediated allergic reactions toward IgG4 production and regulatory T-cell responses, reducing the severity of allergic reactions to insect stings.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom

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:

Allergovac himenoptera CI brief — competitive landscape report
Allergovac himenoptera updates RSS · CI watch RSS
Roxall Medicina España S.A portfolio CI

Frequently asked questions about Allergovac himenoptera

What is Allergovac himenoptera?

Allergovac himenoptera is a Allergen immunotherapy drug developed by Roxall Medicina España S.A.

How does Allergovac himenoptera work?

Allergen immunotherapy that induces immune tolerance to hymenoptera venom through gradual exposure to increasing doses of venom allergens.

Who makes Allergovac himenoptera?

Allergovac himenoptera is developed by Roxall Medicina España S.A (see full Roxall Medicina España S.A pipeline at /company/roxall-medicina-espa-a-s-a).

What drug class is Allergovac himenoptera in?

Allergovac himenoptera belongs to the Allergen immunotherapy class. See all Allergen immunotherapy drugs at /class/allergen-immunotherapy.

What development phase is Allergovac himenoptera in?

Allergovac himenoptera is in Phase 2.

Drug class: All Allergen immunotherapy drugs
Manufacturer: Roxall Medicina España S.A — full pipeline

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