Last reviewed 2026-06-02 · How we verify

Pílulas de Lussen

Laboratorios Osorio de Moraes Ltda. · Phase 3 active Small molecule Under review

Pílulas de Lussen is a Small molecule drug developed by Laboratorios Osorio de Moraes Ltda.. It is currently in Phase 3 development for Various conditions.

Pílulas de Lussen is a medication used to treat various conditions.

Pílulas de Lussen is a medication used to treat dysuria, a condition characterized by painful urination. It has been compared to Pyridium in clinical trials for its efficacy and safety in managing dysuria symptoms.

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	Pílulas de Lussen
Sponsor	Laboratorios Osorio de Moraes Ltda.
Modality	Small molecule
Phase	Phase 3

Mechanism of action

Unfortunately, I do not have enough information to provide a deeper explanation of the mechanism.

Approved indications

Various conditions

Common side effects

No common side effects on file.

Key clinical trials

Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria (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:

Pílulas de Lussen CI brief — competitive landscape report
Pílulas de Lussen updates RSS · CI watch RSS
Laboratorios Osorio de Moraes Ltda. portfolio CI

Frequently asked questions about Pílulas de Lussen

What is Pílulas de Lussen?

Pílulas de Lussen is a Small molecule drug developed by Laboratorios Osorio de Moraes Ltda., indicated for Various conditions.

How does Pílulas de Lussen work?

Pílulas de Lussen is a medication used to treat various conditions.

What is Pílulas de Lussen used for?

Pílulas de Lussen is indicated for Various conditions.

Who makes Pílulas de Lussen?

Pílulas de Lussen is developed by Laboratorios Osorio de Moraes Ltda. (see full Laboratorios Osorio de Moraes Ltda. pipeline at /company/laboratorios-osorio-de-moraes-ltda).

What development phase is Pílulas de Lussen in?

Pílulas de Lussen is in Phase 3.

Manufacturer: Laboratorios Osorio de Moraes Ltda. — full pipeline
Indication: Drugs for Various conditions

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