Last reviewed 2026-05-27 · How we verify

Ceredist (TALTIRELIN)

Phase 2 active Recombinant protein Under review Quality 0/100

Ceredist (generic name: TALTIRELIN) is a taltirelin drug. It is currently in Phase 2 development for Spinocerebellar disease.

Ceredist works by binding to the thyrotropin-releasing hormone receptor, which helps to regulate certain bodily functions.

Ceredist is a thyrotropin-releasing hormone receptor agonist that acts on the thyrotropin-releasing hormone receptor, a protein target. It is classified as a drug in the agonist class, with synonyms including TA-0910, TALTIRELIN, TALTIRELINA, and TALTIRELINE.

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	TALTIRELIN
Drug class	taltirelin
Target	Thyrotropin-releasing hormone receptor
Modality	Recombinant protein
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a system that controls how different parts work together. Ceredist helps to fine-tune this system by blocking or enhancing signals that are sent between different parts of the body. This can help to slow down or stop the progression of certain diseases.

Approved indications

Spinocerebellar disease

Common side effects

No common side effects on file.

Key clinical trials

C-Trelin Orally Disintegrated(OD) Tablet 5mg in Ataxia Due to Spinocerebellar Degeneration (PHASE4)

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:

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

Frequently asked questions about Ceredist

What is Ceredist?

Ceredist (TALTIRELIN) is a taltirelin drug, indicated for Spinocerebellar disease.

How does Ceredist work?

Ceredist works by binding to the thyrotropin-releasing hormone receptor, which helps to regulate certain bodily functions.

What is Ceredist used for?

Ceredist is indicated for Spinocerebellar disease.

What is the generic name of Ceredist?

TALTIRELIN is the generic (nonproprietary) name of Ceredist.

What drug class is Ceredist in?

Ceredist belongs to the taltirelin class. See all taltirelin drugs at /class/taltirelin.

What development phase is Ceredist in?

Ceredist is in Phase 2.

What does Ceredist target?

Ceredist targets Thyrotropin-releasing hormone receptor and is a taltirelin.

Drug class: All taltirelin drugs
Target: All drugs targeting Thyrotropin-releasing hormone receptor
Therapeutic area: All drugs in Other
Indication: Drugs for Spinocerebellar disease

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