Last reviewed 2026-04-19 · How we verify

Fortibone

Frontier Medical and Dental College, Abbotabad · Phase 1 active Small molecule

Fortibone is a Small molecule drug developed by Frontier Medical and Dental College, Abbotabad. It is currently in Phase 1 development.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Fortibone
Sponsor	Frontier Medical and Dental College, Abbotabad
Modality	Small molecule
Therapeutic area	Bone
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia: Pilot Randomized Controlled Trial. (NA)

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:

Fortibone CI brief — competitive landscape report
Fortibone updates RSS · CI watch RSS
Frontier Medical and Dental College, Abbotabad portfolio CI

Frequently asked questions about Fortibone

What is Fortibone?

Fortibone is a Small molecule drug developed by Frontier Medical and Dental College, Abbotabad.

Who makes Fortibone?

Fortibone is developed by Frontier Medical and Dental College, Abbotabad (see full Frontier Medical and Dental College, Abbotabad pipeline at /company/frontier-medical-and-dental-college-abbotabad).

What development phase is Fortibone in?

Fortibone is in Phase 1.

Manufacturer: Frontier Medical and Dental College, Abbotabad — full pipeline
Therapeutic area: All drugs in Bone

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