Last reviewed 2026-06-02 · How we verify

menatetranone (MK4)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3 active Small molecule ✓ Verified Jun 2026

menatetranone (MK4) is a Vitamin K2 analog Small molecule drug developed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is currently in Phase 3 development for Osteoporosis prevention and treatment, Bone mineral density improvement in postmenopausal women.

Menatetrenone (MK4) is a form of vitamin K2 that activates vitamin K-dependent proteins involved in bone mineralization and vascular calcification regulation.

Menatetranone (MK4) is a small molecule that has been studied in clinical trials for its potential effects on osteoporosis. It was compared to phylloquinone (K1) in a 2005 study on bone turnover in postmenopausal women.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	menatetranone (MK4)
Sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Drug class	Vitamin K2 analog
Target	Vitamin K-dependent carboxylase (GGCX)
Modality	Small molecule
Therapeutic area	Bone metabolism / Osteoporosis
Phase	Phase 3

Mechanism of action

MK4 functions as a cofactor for gamma-carboxylation of osteocalcin and matrix Gla protein, which are critical for bone formation and prevention of vascular calcification. By enhancing the carboxylation of these vitamin K-dependent proteins, MK4 promotes bone mineral density and may reduce fracture risk while preventing pathological calcification in soft tissues.

Approved indications

Osteoporosis prevention and treatment
Bone mineral density improvement in postmenopausal women

Common side effects

Gastrointestinal disturbances
Headache
Generally well-tolerated

Key clinical trials

Vitamin K and Bone Turnover in Postmenopausal Women (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:

menatetranone (MK4) CI brief — competitive landscape report
menatetranone (MK4) updates RSS · CI watch RSS
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) portfolio CI

Frequently asked questions about menatetranone (MK4)

What is menatetranone (MK4)?

menatetranone (MK4) is a Vitamin K2 analog drug developed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), indicated for Osteoporosis prevention and treatment, Bone mineral density improvement in postmenopausal women.

How does menatetranone (MK4) work?

Menatetrenone (MK4) is a form of vitamin K2 that activates vitamin K-dependent proteins involved in bone mineralization and vascular calcification regulation.

What is menatetranone (MK4) used for?

menatetranone (MK4) is indicated for Osteoporosis prevention and treatment, Bone mineral density improvement in postmenopausal women.

Who makes menatetranone (MK4)?

menatetranone (MK4) is developed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (see full National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) pipeline at /company/national-institute-of-diabetes-and-digestive-and-kidney-diseases-niddk).

What drug class is menatetranone (MK4) in?

menatetranone (MK4) belongs to the Vitamin K2 analog class. See all Vitamin K2 analog drugs at /class/vitamin-k2-analog.

What development phase is menatetranone (MK4) in?

menatetranone (MK4) is in Phase 3.

What are the side effects of menatetranone (MK4)?

Common side effects of menatetranone (MK4) include Gastrointestinal disturbances, Headache, Generally well-tolerated.

What does menatetranone (MK4) target?

menatetranone (MK4) targets Vitamin K-dependent carboxylase (GGCX) and is a Vitamin K2 analog.

Drug class: All Vitamin K2 analog drugs
Target: All drugs targeting Vitamin K-dependent carboxylase (GGCX)
Manufacturer: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — full pipeline
Therapeutic area: All drugs in Bone metabolism / Osteoporosis
Indication: Drugs for Osteoporosis prevention and treatment
Indication: Drugs for Bone mineral density improvement in postmenopausal women

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