Last reviewed 2026-05-27 · How we verify

Brinaldix (CLOPAMIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Brinaldix (generic name: CLOPAMIDE) is a clopamide drug. It is currently in Phase 2 development.

Brinaldix works by inhibiting the reabsorption of water in the kidneys, allowing the body to excrete excess fluids.

Brinaldix is a small molecule modality. It is also known by the synonyms AQUEX, CLOPAMIDA, CLOPAMIDE, and DT-327.

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	CLOPAMIDE
Drug class	clopamide
Modality	Small molecule
Therapeutic area	Nephrology
Phase	Phase 2

Mechanism of action

Think of it like a faucet - when you turn the faucet on, water flows out. In the kidneys, there's a 'faucet' that controls how much water is reabsorbed back into the body. Brinaldix turns down this faucet, allowing more water to be excreted in the urine, which helps to reduce excessive thirst and urination.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Brinaldix CI brief — competitive landscape report
Brinaldix updates RSS · CI watch RSS

Frequently asked questions about Brinaldix

What is Brinaldix?

Brinaldix (CLOPAMIDE) is a clopamide drug.

How does Brinaldix work?

Brinaldix works by inhibiting the reabsorption of water in the kidneys, allowing the body to excrete excess fluids.

What is the generic name of Brinaldix?

CLOPAMIDE is the generic (nonproprietary) name of Brinaldix.

What drug class is Brinaldix in?

Brinaldix belongs to the clopamide class. See all clopamide drugs at /class/clopamide.

What development phase is Brinaldix in?

Brinaldix is in Phase 2.

Drug class: All clopamide drugs
Therapeutic area: All drugs in Nephrology

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