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Osteo D (SECALCIFEROL)

Phase 2 active Small molecule

Osteo D (generic name: SECALCIFEROL) is a secalciferol drug. It is currently in Phase 2 development.

Secalciferol works by binding to vitamin D receptors in the body, triggering a response that increases calcium and phosphate levels.

Osteo D (Secalciferol) is a small molecule drug in the secalciferol class, used to treat vitamin D deficiency. It works by stimulating the production of calcium and phosphate in the body, which is essential for bone growth and maintenance. The commercial status of Osteo D is unknown, and it is not clear if it is patented or generic. Key safety considerations include potential interactions with other medications and monitoring of calcium levels. Secalciferol is a form of vitamin D that is naturally produced in the skin upon exposure to sunlight.

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 nameSECALCIFEROL
Drug classsecalciferol
ModalitySmall molecule
Therapeutic areaBone
PhasePhase 2

Mechanism of action

Imagine your body has a special lock that only opens with a specific key. Vitamin D receptors are like those locks, and secalciferol is the key that fits perfectly. When secalciferol binds to these receptors, it sends a signal to the body to increase the production of calcium and phosphate, which are essential for building and maintaining strong bones.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Osteo D

What is Osteo D?

Osteo D (SECALCIFEROL) is a secalciferol drug.

How does Osteo D work?

Secalciferol works by binding to vitamin D receptors in the body, triggering a response that increases calcium and phosphate levels.

What is the generic name of Osteo D?

SECALCIFEROL is the generic (nonproprietary) name of Osteo D.

What drug class is Osteo D in?

Osteo D belongs to the secalciferol class. See all secalciferol drugs at /class/secalciferol.

What development phase is Osteo D in?

Osteo D is in Phase 2.

Related

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