Last reviewed 2026-05-19 · How we verify

Actebral (CYPRODENATE)

Phase 2 active Small molecule ✓ Verified May 2026

Actebral (generic name: CYPRODENATE) is a drug. It is currently in Phase 2 development.

Actebral works by interacting with a specific molecular target to produce a therapeutic effect.

Actebral is a small molecule with the synonyms ACTEBRAL, CIPRODENATO, CYPRODENATE, LB 125, LB-125, and RD 406. It is being studied in a clinical trial for the treatment of Idiopathic Pulmonary Fibrosis, where it is being compared to a placebo in combination with bosentan.

Likelihood of approval

13.3% 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).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

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	CYPRODENATE
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Actebral is a key that fits into one of those locks. When it binds to the lock, it triggers a series of events that ultimately lead to the desired therapeutic effect, such as reducing inflammation or killing cancer cells.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis (PHASE2,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:

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

Frequently asked questions about Actebral

What is Actebral?

Actebral (CYPRODENATE) is a Small molecule drug.

How does Actebral work?

Actebral works by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Actebral?

CYPRODENATE is the generic (nonproprietary) name of Actebral.

What development phase is Actebral in?

Actebral is in Phase 2.

Therapeutic area: All drugs in Oncology

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