Last reviewed 2026-05-27 · How we verify

Carboethoxyphthalazinohydrazine (TODRALAZINE)

Phase 2 active Small molecule ✓ Verified May 2026

Carboethoxyphthalazinohydrazine (generic name: TODRALAZINE) is a todralazine drug. It is currently in Phase 2 development.

Todralazine is thought to work by modulating the body's response to certain stimuli, although the exact details of its mechanism are unclear.

Carboethoxyphthalazinohydrazine is a small molecule with the synonyms BT-621 FREE BASE, CEPH, CEPH FREE BASE, NSC-757868, TODRALAZINA, and TODRALAZINE.

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	TODRALAZINE
Drug class	todralazine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's response to certain stimuli is like a volume control on a radio. Todralazine is thought to adjust this volume control, making it easier for your body to respond to certain signals. This can help with various bodily functions, but the specifics of how it 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:

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

Frequently asked questions about Carboethoxyphthalazinohydrazine

What is Carboethoxyphthalazinohydrazine?

Carboethoxyphthalazinohydrazine (TODRALAZINE) is a todralazine drug.

How does Carboethoxyphthalazinohydrazine work?

Todralazine is thought to work by modulating the body's response to certain stimuli, although the exact details of its mechanism are unclear.

What is the generic name of Carboethoxyphthalazinohydrazine?

TODRALAZINE is the generic (nonproprietary) name of Carboethoxyphthalazinohydrazine.

What drug class is Carboethoxyphthalazinohydrazine in?

Carboethoxyphthalazinohydrazine belongs to the todralazine class. See all todralazine drugs at /class/todralazine.

What development phase is Carboethoxyphthalazinohydrazine in?

Carboethoxyphthalazinohydrazine is in Phase 2.

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

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