Last reviewed 2026-05-21 · How we verify

Osten (IPRIFLAVONE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 31/100

Osten (generic name: IPRIFLAVONE) is a ipriflavone drug. It is currently in Phase 2 development for Postmenopausal osteoporosis.

Osten works by inhibiting the sodium-dependent noradrenaline transporter, which helps to regulate bone metabolism.

Osten is a small molecule with the synonyms 7-ISOPROPOXYISOFLAVONE, IPRIFLAVONA, IPRIFLAVONE, IPRIFLAVONE, NSC-755888.

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	IPRIFLAVONE
Drug class	ipriflavone
Target	Sodium-dependent noradrenaline transporter
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of bone metabolism like a bank account. When you're young, your body is constantly depositing and withdrawing bone tissue. As you age, especially after menopause, your body starts to withdraw more bone tissue than it deposits, leading to osteoporosis. Osten helps to slow down this withdrawal process by blocking the transporter that regulates the withdrawal of bone tissue.

Approved indications

Postmenopausal osteoporosis

Common side effects

No common side effects on file.

Key clinical trials

Biomarker-based Trial of NPC-1 for Alzheimer's Pathology (PHASE1,PHASE2)

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:

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

Frequently asked questions about Osten

What is Osten?

Osten (IPRIFLAVONE) is a ipriflavone drug, indicated for Postmenopausal osteoporosis.

How does Osten work?

Osten works by inhibiting the sodium-dependent noradrenaline transporter, which helps to regulate bone metabolism.

What is Osten used for?

Osten is indicated for Postmenopausal osteoporosis.

What is the generic name of Osten?

IPRIFLAVONE is the generic (nonproprietary) name of Osten.

What drug class is Osten in?

Osten belongs to the ipriflavone class. See all ipriflavone drugs at /class/ipriflavone.

What development phase is Osten in?

Osten is in Phase 2.

What does Osten target?

Osten targets Sodium-dependent noradrenaline transporter and is a ipriflavone.

Drug class: All ipriflavone drugs
Target: All drugs targeting Sodium-dependent noradrenaline transporter
Therapeutic area: All drugs in Metabolic
Indication: Drugs for Postmenopausal osteoporosis

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