Last reviewed 2026-05-27 · How we verify

Solo 0.3 group

ANRS, Emerging Infectious Diseases · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

Solo 0.3 group is a Biologic drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 1 development.

The Solo 0.3 group was a part of a study comparing inhaled and intravenous milrinone for patients undergoing mitral valve replacement surgery. This group was likely one of the groups in the study, but the exact details of the Solo 0.3 group are not specified in the provided facts.

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	Solo 0.3 group
Sponsor	ANRS, Emerging Infectious Diseases
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

Solo 0.3 group CI brief — competitive landscape report
Solo 0.3 group updates RSS · CI watch RSS
ANRS, Emerging Infectious Diseases portfolio CI

Frequently asked questions about Solo 0.3 group

What is Solo 0.3 group?

Solo 0.3 group is a Biologic drug developed by ANRS, Emerging Infectious Diseases.

Who makes Solo 0.3 group?

Solo 0.3 group is developed by ANRS, Emerging Infectious Diseases (see full ANRS, Emerging Infectious Diseases pipeline at /company/anrs-emerging-infectious-diseases).

What development phase is Solo 0.3 group in?

Solo 0.3 group is in Phase 1.

Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline

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