Last reviewed 2026-05-21 · How we verify

Budesolv

Marinomed Biotech AG · Phase 3 active Small molecule ✓ Verified May 2026

Budesolv is a Small molecule drug developed by Marinomed Biotech AG. It is currently in Phase 3 development. Also known as: Budesonide.

Budesolv is a nasal spray used to treat conditions such as Allergic Rhinitis, Allergic Conjunctivitis, and Hayfever. It is compared to the marketed nasal spray Rhinocort in clinical trials, with the goal of demonstrating therapeutic equivalence and early onset of action.

Likelihood of approval

58.3% 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).

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	Budesolv
Also known as	Budesonide
Sponsor	Marinomed Biotech AG
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Demonstration of Equivalence and Early Onset of a Novel Anti-allergic Nasal Spray Compared to Marketed Nasal Spray (PHASE3)

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:

Budesolv CI brief — competitive landscape report
Budesolv updates RSS · CI watch RSS
Marinomed Biotech AG portfolio CI

Frequently asked questions about Budesolv

What is Budesolv?

Budesolv is a Small molecule drug developed by Marinomed Biotech AG.

Who makes Budesolv?

Budesolv is developed by Marinomed Biotech AG (see full Marinomed Biotech AG pipeline at /company/marinomed-biotech-ag).

Is Budesolv also known as anything else?

Budesolv is also known as Budesonide.

What development phase is Budesolv in?

Budesolv is in Phase 3.

Manufacturer: Marinomed Biotech AG — full pipeline
Therapeutic area: All drugs in Other
Also known as: Budesonide

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