Drug

Rovatirelin clinical trials

Also written KPS-0373.

studies test it: 9
open now: 0
in phase 3: 6
first study started: 2013

How each study uses rovatirelin is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Approvals

The first approval found in each region, with its record

United States: Not in FDA's approval records
European Union: Not in EMA's list of EU-wide authorisations

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

KPS-0373, High dose: 4
KPS-0373, Low dose: 4

Development codes

KPS-0373: 5

Studies by the year they started

3 studies that test it; most in 2013 (1)

Studies that test rovatirelin, by start year
Year	Studies
2013	1
2016	1
2025	1

By phase

A phase 1/2 study counts in both.

Phase 2: 3
Phase 3: 6

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Spinocerebellar Degenerations: 9

Who runs them

Industry 9 · Other 0

Kissei Pharmaceutical Co., Ltd. (9)

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Reaching primary completion within a year · 1, 1 in phase 3

Studies that test rovatirelin, phase 3 first.

Mar 2027Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar DegenerationPhase 3 · Kissei Pharmaceutical Co., Ltd.

Studies

Open first, then newest update. How each study uses rovatirelin is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 9

Codes

What other systems call rovatirelin · ClinicalTrials.gg INT000457

MeSH (NLM) C000607550rovatirelinOne source NLM
UNII (FDA) 9DL0X410PYROVATIRELINConfirmed FDA, NLM, Wikidata
Wikidata Q27272404rovatirelinConfirmed FDA, NLM, Wikidata
NCI Thesaurus C152262RovatirelinOne source FDA
DrugBank DB15338One source Wikidata

System	Code	Name there	Checked by
MeSH (NLM)	C000607550	rovatirelin	One source NLM
UNII (FDA)	9DL0X410PY	ROVATIRELIN	Confirmed FDA, NLM, Wikidata
Wikidata	Q27272404	rovatirelin	Confirmed FDA, NLM, Wikidata
NCI Thesaurus	C152262	Rovatirelin	One source FDA
DrugBank	DB15338	—	One source Wikidata

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.