Last reviewed 2026-06-01 · How we verify

HRZE plus AlpE625

BioVersys AG · Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 35/100

HRZE plus AlpE625 is a Antituberculosis combination therapy Small molecule drug developed by BioVersys AG. It is currently in Phase 2 development.

Combines standard HRZE tuberculosis therapy with AlpE625, an adjuvant that enhances antibiotic activity against Mycobacterium tuberculosis.

HRZE is a treatment for Tuberculosis Meningitis, and it is being studied in combination with AlpE625 (also known as Alpibectir) in a Phase 2a trial to evaluate its pharmacokinetics and safety.

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	HRZE plus AlpE625
Sponsor	BioVersys AG
Drug class	Antituberculosis combination therapy
Modality	Small molecule
Phase	Phase 2

Mechanism of action

AlpE625 is designed to work synergistically with standard tuberculosis antibiotics in the HRZE regimen. The compound acts as an adjuvant to potentiate the activity of existing TB drugs, potentially allowing for shorter treatment duration or improved efficacy against drug-resistant strains.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis (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:

HRZE plus AlpE625 CI brief — competitive landscape report
HRZE plus AlpE625 updates RSS · CI watch RSS
BioVersys AG portfolio CI

Frequently asked questions about HRZE plus AlpE625

What is HRZE plus AlpE625?

HRZE plus AlpE625 is a Antituberculosis combination therapy drug developed by BioVersys AG.

How does HRZE plus AlpE625 work?

Combines standard HRZE tuberculosis therapy with AlpE625, an adjuvant that enhances antibiotic activity against Mycobacterium tuberculosis.

Who makes HRZE plus AlpE625?

HRZE plus AlpE625 is developed by BioVersys AG (see full BioVersys AG pipeline at /company/bioversys-ag).

What drug class is HRZE plus AlpE625 in?

HRZE plus AlpE625 belongs to the Antituberculosis combination therapy class. See all Antituberculosis combination therapy drugs at /class/antituberculosis-combination-therapy.

What development phase is HRZE plus AlpE625 in?

HRZE plus AlpE625 is in Phase 2.

Drug class: All Antituberculosis combination therapy drugs
Manufacturer: BioVersys AG — full pipeline

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