P-15 (Osteogenic Cell Binding Peptide)_Dosage, benefits & legal status
Also known as P15, PepGen P-15, i-FACTOR, PearlMatrix, GTPGPQGIAGQRGVV
A bone graft peptide with its own FDA device category.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is P-15 (Osteogenic Cell Binding Peptide)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is a short piece of collagen, copied and made in a factory, then painted onto tiny mineral granules that a surgeon packs into the spine. The theory is simple: bone-building cells recognize that patch of collagen and grab onto it, so coating the granules gives those cells somewhere to land and bone forms faster. It is worth knowing two things. It has never been approved as a drug anywhere, only as an implanted device, and nobody has shown it does anything useful as a loose peptide without the carrier underneath it. The newer spine trial that won approval in 2025 looks impressive until you read FDA's own review. It says the result came mainly from the comparison group doing badly.
P-15 is a synthetic fifteen-residue peptide, GTPGPQGIAGQRGVV, corresponding to residues 766 to 780 of the alpha-1 chain of type I collagen. It is used as a surface coating on an anorganic bone mineral carrier rather than as a free peptide, and its stated mechanism is to present a collagen binding motif that osteogenic cells attach to, concentrating them on the graft surface and accelerating the normal bone healing sequence. FDA treats it as a device rather than a drug and has assigned it a product code of its own, NOX, defined as Filler, Bone Void, Synthetic Peptide, Class 3 and requiring premarket approval. Two premarket approvals carry it: P140019 for i-FACTOR Peptide Enhanced Bone Graft, approved November 3, 2015, and P240001 for PearlMatrix, approved June 18, 2025.
What it's used for
Packed into the disc space during spinal fusion surgery as a graft material, in place of or alongside a patient's own bone. It is a surgical implant, not something prescribed, injected or taken at home.
How does P-15 (Osteogenic Cell Binding Peptide) work?
What it does in the body, and where.The whole design rests on one idea: cells recognize collagen, so copying the part of collagen they grip and putting it on a graft surface should bring them there. Whether that idea has been demonstrated depends on how the peptide is presented.
- 01It is a copy of a real collagen motifThe sequence GTPGPQGIAGQRGVV is residues 766 to 780 of the alpha-1 chain of type I collagen. This is not a designed molecule or an analog: it is a literal fifteen-residue excerpt from the most abundant protein in bone, chosen because cells involved in bone formation attach to that region.
- 02The carrier is not optionalThe peptide is used as a surface coating on anorganic bone mineral granules. Attachment motifs work by being displayed on a surface that a cell can press against and pull on, so the same sequence floating free in solution has nothing to anchor. A 2024 narrative review of the peptide reports no evidence supporting an effect for the free peptide, and every approval covers the coated product rather than the molecule.
- 03Cells land, then normal healing proceedsOnce osteogenic cells are concentrated on the graft surface, the sequence that follows is ordinary bone healing: attachment, proliferation, mineralization and eventual bridging of the gap. The peptide is not claimed to be a growth factor and does not signal cells to multiply the way a bone morphogenetic protein does. It is best read as a landing surface rather than an instruction.
- 04The 2025 result needs its caveatIn the trial supporting approval, 24-month composite clinical success was 55.4% against 36.4% for autograft, a risk-adjusted difference of 18.9% with a 90% confidence interval of 8.7 to 29.1 and a one-sided p value of 0.0012. FDA's own summary of safety and effectiveness states the win was driven mainly by the fusion rate in the control arm, meaning the comparison group fused worse than expected rather than the device performing beyond expectation. Secondary surgeries also ran higher in the device arm, at 9.1% against 2.7%.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
The 2025 spine trial
peer-reviewed-human- Human trial299 randomized, 293 analyzed. Composite clinical success at 24 months 55.4% against 36.4%, risk-adjusted difference 18.9% (90% CI 8.7 to 29.1), one-sided p 0.0012.
- Human trialCT fusion 58.8%, 72.5% and 83.7% against 28.5%, 43.1% and 57.3%. Time to fusion hazard ratio 1.87 (1.47 to 2.38).
- Human trialSecondary surgeries were more common in the device arm, 9.1% against 2.7%.
What the regulator said about that win
FDA-approved- RegulatoryFDA's summary of safety and effectiveness states the result was driven mainly by the fusion rate in the control arm, not by the device exceeding expectation.
- No dataPublished 24-month VAS back pain and SF-12 outcomes numerically favored autograft and were not prespecified.
The older approval proved less than people think
peer-reviewed-human- Human trialThe 2016 cervical trial was a non-inferiority study: 319 randomized, fusion 88.97% against 85.82%, difference 3.15% with a confidence interval crossing zero.
- Regulatoryi-FACTOR was approved November 3, 2015 under P140019; PearlMatrix followed on June 18, 2025 under P240001.
The peptide alone has nothing behind it
none- ReviewA 2024 narrative review of the mechanism reports no evidence for an effect of the free peptide; the activity belongs to the peptide coated on a carrier.
- No dataA research reagent catalog lists the bare fifteen-residue peptide for sale with no research-use-only statement attached. That is a mismatch worth knowing about, since no approval covers the free molecule.
- RegulatoryFDA created product code NOX, Filler, Bone Void, Synthetic Peptide, Class 3, specifically for this material.
The most common error is calling this an FDA-approved peptide without saying what was approved. Two premarket approvals cover implantable devices whose graft granules carry the peptide as a coating, and no regulator has approved it as a drug. The second error is quoting the 2025 composite clinical success figures without FDA's own caveat that the win was driven mainly by the fusion rate in the control arm, and without the higher secondary surgery rate in the device arm. The third is treating the 2016 cervical trial as a superiority result: it was non-inferiority, with a difference of 3.15% and a confidence interval crossing zero. The fourth is the Medicare claim. What was granted is an inpatient new technology add-on payment effective October 1, 2026, worth up to 65% reimbursement of the additional cost, not general new Medicare reimbursement, and the April 2026 group purchasing agreement is a pricing contract rather than a coverage decision. Last, i-FACTOR and PearlMatrix are two different devices under two different approvals, not alternative names for one product.
The published record
Papers and trials about P-15 (Osteogenic Cell Binding Peptide)
Searched: P-15 peptide, i-FACTOR, PearlMatrix, GTPGPQGIAGQRGVV, ABM/P-15.
Left out: P15 (the single most dangerous term on this row. Unspaced it retrieves p15INK4b, a cyclin-dependent kinase inhibitor tumor suppressor with a large oncology literature and no relationship to this peptide. Never loosen the row to this); p15INK4b (named explicitly so the rejection survives anyone tempted to add the bare numeric form); bone graft (a vast orthopedic literature covering autograft, allograft, ceramics and bone morphogenetic proteins, almost none of it about this peptide); collagen peptide (an enormous oral supplement literature about hydrolyzed collagen, a completely different product category); type I collagen (the parent protein this fifteen-residue stretch is excerpted from, with a century of structural biology behind it); bone morphogenetic protein (a different class of bone graft adjunct, frequently discussed alongside this device and frequently mistaken for it); spinal fusion (a very large surgical literature; the row must stay anchored on the material, not the operation).
92 papers tagged human · 79 not reviews or lab · 6 clinical trial publications
Furthest stage reached: Approved outside the US, European Union, Australia, Canada
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 498 papers and 0 trials indexed in detail.
At a glance
Four things to know about P-15 (Osteogenic Cell Binding Peptide)
Evidence
Clinical use
Category
Healing and recovery
Common vial
Varies
Half-life
Not applicable
How much, and do you cycle it?
The range, and whether you take breaks.Set by the device; the peptide mass per unit is not published, once, during the operation. Single surgical implantation Trial dose
It is implanted once during an operation and left in place. No repeat administration or cycling scheme exists.
Not applicableNo figure
No circulating half-life has been published and none would be meaningful. The peptide is implanted as a coating on a graft carrier and is intended to stay at the surgical site rather than circulate.
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Given in hospital from a prepared product, so there is nothing to mix.
The surgeon fills the disc space with the device as supplied. The peptide is a coating on the carrier granules and the mass per unit is not published, so there is no dose figure to give.
How do you store it?
Before mixing, and after.Given in a hospital or trial clinic, so the pharmacy stores it.
P-15 (Osteogenic Cell Binding Peptide) is prepared and given by hospital, clinic or trial staff, following the product label or the trial protocol. Some products like this arrive ready to use and others are mixed just before the dose, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 20% charged residues, 40% hydrophobic. Acid may help.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Any expectation of an effect from the peptide on its own: a 2024 review of the mechanism reports no evidence for the free peptide, only for the coated carrier
- Treating a device approval as a drug approval, since no regulator anywhere has approved this peptide as a medicine
- Reading the 2025 fusion result without the regulator's own caveat about the comparison arm
Stop and get help
- Signs of infection at the surgical site, such as spreading redness, fever or drainage
- New or worsening leg weakness, numbness or loss of bladder control after the operation
Common effects
- Nothing attributable to the peptide itself apart from the recovery expected after spinal fusion surgery.
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is P-15 (Osteogenic Cell Binding Peptide) approved?
And where the numbers on this page come from.Yes, for some uses. P-15 (Osteogenic Cell Binding Peptide) is FDA approved on prescription for specific indications. Other uses it is sought for are not covered by that approval. It is approved in the European Union, Australia, and Canada, but not in the United States.
- Approval statusClinical use
- RouteImplanted during spine surgery, coated on a mineral carrier
- Checked1 November 2026
- Approved outside the USEuropean Union, Australia, Canada.This does not change the United States position above.
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesSpine, P-15 peptide enhanced bone graft in transforaminal lumbar interbody fusionSpine, time to fusion with P-15 peptide enhanced bone graftSpine, efficacy of i-FACTOR bone graft versus autograft in anterior cervical fusionBioengineering, the osteogenic peptide P-15 for bone regeneration, a narrative reviewFDA device classification record, product code NOXFDA premarket approval records for P140019 and P240001
What has happened recently
FDA regulates this peptide as a device and gave it a classification of its own. Product code NOX is defined as Filler, Bone Void, Synthetic Peptide, device Class 3, premarket approval required, and the classification record lists premarket approvals P140019, P100006 and P240001 against it. P140019 covers i-FACTOR Peptide Enhanced Bone Graft, applicant Cerapedics LLC, original approval dated November 3, 2015 with an Orthopedic advisory committee. P240001 covers PearlMatrix, approved June 18, 2025, also Orthopedic committee. That approval has since been widened and adjusted: supplement S001, dated December 11, 2025, adds the ALIF, TLIF, PLIF, OLIF-ATP and LLIF surgical approaches along with titanium cages, and supplement S003, dated September 16, 2026, is a thirty-day notice covering a manufacturing change at a contract peptide manufacturing site. None of this is drug approval. Separately, the Medicare position is narrower than it is usually described: this is an inpatient prospective payment system new technology add-on payment effective October 1, 2026, worth up to 65% reimbursement of the additional cost, so calling it new Medicare reimbursement overstates what was granted. A group purchasing agreement dated April 24, 2026 is a pricing contract and carries no effective date of its own.
You can compare this against the whole library, or read how to check a seller.
What else is like P-15 (Osteogenic Cell Binding Peptide)?
Others in Healing and recovery, side by side.If you're weighing P-15 (Osteogenic Cell Binding Peptide), it's worth reading P11-4 (Oligopeptide-104), Palopegteriparatide (Yorvipath), and Pentosan Polysulfate (PPS) in the same class.
A bone graft peptide with its own FDA device category.
- Dose
- Set by the device; the peptide mass per unit is not published
- How often
- Once, during the operation
A dental peptide its own label files as inactive.
- Dose
- Set by the finished product; no peptide strength appears on the label
- How often
- As the product directs
Teriparatide tethered to a large PEG carrier through a linker that lets it go slowly, so one daily injection gives steady hormone levels. In the pivotal trial 68.9% met the FDA's goal against 4.8% on placebo.
- Dose
- 18 mcg once daily to start, adjusted within 6 to 30 mcg (label)
- How often
- Once daily
A treatment for arthritis and painful bladder that acts like a joint lubricant.
- Dose
- 300 mg per day (100 mg three times a day)
- How often
- Three times a day (oral)
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Spine, P-15 peptide enhanced bone graft in transforaminal lumbar interbody fusion(2025)Volume 51, pages 238 to 247. The ASPIRE randomized trial, conducted under investigational device exemption G170300 and registered as NCT03438747. 299 patients randomized, 293 in the modified intention to treat set. At 24 months composite clinical success was 55.4%, that is 67 of 121, against 36.4%, or 47 of 129, for autograft. The risk-adjusted difference was 18.9% with a 90% confidence interval of 8.7 to 29.1 and a one-sided p value of 0.0012. CT fusion ran 58.8%, 72.5% and 83.7% against 28.5%, 43.1% and 57.3% across time points.
- Spine, time to fusion with P-15 peptide enhanced bone graft(2025)Volume 51, pages 229 to 237. The companion time-to-fusion analysis from the same trial, reporting a hazard ratio of 1.87 with a 95% confidence interval of 1.47 to 2.38. Published 24-month VAS back pain and SF-12 outcomes numerically favored autograft and were not prespecified, so they do not support a symptom benefit.
- Spine, efficacy of i-FACTOR bone graft versus autograft in anterior cervical fusion(2016)Volume 41, pages 1075 to 1083. The pivotal trial behind the 2015 approval, 319 patients randomized. Fusion was 88.97% against 85.82%, a difference of 3.15% with a confidence interval crossing zero. This was a non-inferiority study, so it established that the device was not worse rather than that it was better, a distinction routinely lost when the two trials are described together.
- Bioengineering, the osteogenic peptide P-15 for bone regeneration, a narrative review(2024)Volume 11, article 599. A review of the mechanism and the evidence. The finding that matters for anyone encountering this peptide outside a surgical context is that it reports no evidence supporting an effect for the free peptide: the activity described in the literature belongs to the peptide presented on a carrier surface.
- FDA device classification record, product code NOX(2026)FDA created a device category specifically for this material. Product code NOX, Filler, Bone Void, Synthetic Peptide, device class 3, premarket approval required, GMP exempt flag N. The record lists premarket approvals P140019, P100006 and P240001. This is the clearest single piece of evidence that the regulatory identity here is a device rather than a drug.
- FDA premarket approval records for P140019 and P240001(2026)P140019, original record with a blank supplement number, decision date November 3, 2015, applicant Cerapedics LLC, trade name I-FACTOR PEPTIDE ENHANCED BONE GRAFT, Orthopedic advisory committee. The newer approval P240001 for PearlMatrix carries an original decision date of June 18, 2025, with supplement S001 on December 11, 2025 adding the ALIF, TLIF, PLIF, OLIF-ATP and LLIF approaches and titanium cages, and supplement S003 on September 16, 2026 as a thirty-day notice for a manufacturing change.
Beyond these, 498 records are indexed. Browse the records