Last reviewed 2026-05-28 · How we verify

CALDIAMIDE

Phase 2 active Small molecule ✓ Verified May 2026

CALDIAMIDE is a caldiamide drug. It is currently in Phase 2 development.

Caldiamide is a small molecule that works by interacting with a specific target, although its exact mechanism of action is currently unknown.

Caldiamide is a small molecule drug in the caldiamide class, but its target and mechanism of action are unknown. It is not clear if it has been approved by the FDA or if it is commercially available. There is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Further research is needed to understand its clinical applications and safety profile. As a result, it is difficult to provide a comprehensive summary of caldiamide's status and characteristics.

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	CALDIAMIDE
Drug class	caldiamide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and caldiamide is a key that fits into one of those locks. When it binds to the lock, it can either turn the lock open or closed, depending on the type of lock and the key's shape. This can affect how the cell works and responds to signals, but the exact details of how caldiamide works are still being studied.

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:

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

Frequently asked questions about CALDIAMIDE

What is CALDIAMIDE?

CALDIAMIDE is a caldiamide drug.

How does CALDIAMIDE work?

Caldiamide is a small molecule that works by interacting with a specific target, although its exact mechanism of action is currently unknown.

What drug class is CALDIAMIDE in?

CALDIAMIDE belongs to the caldiamide class. See all caldiamide drugs at /class/caldiamide.

What development phase is CALDIAMIDE in?

CALDIAMIDE is in Phase 2.

Drug class: All caldiamide drugs
Therapeutic area: All drugs in Other

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