Last reviewed 2026-04-20 · How we verify

Disdolen (FOSFOSAL)

Phase 2 active Small molecule

Disdolen (generic name: FOSFOSAL) is a fosfosal drug. It is currently in Phase 2 development.

Disdolen (FOSFOSAL) is thought to work by modulating physiological processes, but the exact mechanism is unknown.

Disdolen (FOSFOSAL) is a small molecule drug in the fosfosal class, but details about its target, FDA approval status, and approved indications are unknown. Its commercial status, generic manufacturers, and patent status are also unclear. As a fosfosal, it is likely involved in modulating physiological processes, but specific mechanisms and safety considerations are not well-documented. Further research is needed to understand its therapeutic potential and safety profile. Its development and ownership history are also unclear.

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	FOSFOSAL
Drug class	fosfosal
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's physiological processes as a complex orchestra. Disdolen (FOSFOSAL) is like a conductor that helps the different parts work together, but we don't know exactly how it does this or what specific parts it affects. This is a simplified explanation, and the actual mechanism is likely much more complex.

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:

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

Frequently asked questions about Disdolen

What is Disdolen?

Disdolen (FOSFOSAL) is a fosfosal drug.

How does Disdolen work?

Disdolen (FOSFOSAL) is thought to work by modulating physiological processes, but the exact mechanism is unknown.

What is the generic name of Disdolen?

FOSFOSAL is the generic (nonproprietary) name of Disdolen.

What drug class is Disdolen in?

Disdolen belongs to the fosfosal class. See all fosfosal drugs at /class/fosfosal.

What development phase is Disdolen in?

Disdolen is in Phase 2.

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

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