Last reviewed 2026-05-23 · How we verify

Osigraft (EPTOTERMIN ALFA)

Olympus Biotech International Limited · FDA-approved approved Recombinant protein Under review Quality 13/100

Osigraft (generic name: EPTOTERMIN ALFA) is a Recombinant protein drug developed by Olympus Biotech International Limited. It is currently FDA-approved (first approved 2001) for Nonunion of fracture.

Osigraft, also known as OP-1, is a protein that acts as an agonist for the bone morphogenetic protein receptor type-1A. It is being studied as a potential treatment for osteoarthritis of the knee through intra-articular injection.

At a glance

Generic name	EPTOTERMIN ALFA
Sponsor	Olympus Biotech International Limited
Modality	Recombinant protein
Therapeutic area	Bone
Phase	FDA-approved
First approval	2001

Approved indications

Nonunion of fracture

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee (PHASE1)

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
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
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:

Osigraft CI brief — competitive landscape report
Osigraft updates RSS · CI watch RSS
Olympus Biotech International Limited portfolio CI

Frequently asked questions about Osigraft

What is Osigraft?

Osigraft (EPTOTERMIN ALFA) is a Recombinant protein drug developed by Olympus Biotech International Limited, indicated for Nonunion of fracture.

What is Osigraft used for?

Osigraft is indicated for Nonunion of fracture.

Who makes Osigraft?

Osigraft is developed and marketed by Olympus Biotech International Limited (see full Olympus Biotech International Limited pipeline at /company/olympus-biotech-international-limited).

What is the generic name of Osigraft?

EPTOTERMIN ALFA is the generic (nonproprietary) name of Osigraft.

When was Osigraft approved?

Osigraft was first approved on 2001.

What development phase is Osigraft in?

Osigraft is FDA-approved (marketed).

Manufacturer: Olympus Biotech International Limited — full pipeline
Therapeutic area: All drugs in Bone
Indication: Drugs for Nonunion of fracture

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