ORJ-001 (NP-201)_Dosage, benefits & legal status
Also known as NP-201, NP-201 acetate, NIPEP-PF
A synthetic 19-amino-acid peptide meant to switch on beta-1 integrin and help the lining of the lungs repair itself. Its phase 2 in pulmonary fibrosis screened its first patient in October 2026.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is ORJ-001 (NP-201)?
Plain language first. The technical label stays, but it never stands alone.Overview
Idiopathic pulmonary fibrosis is scarring of the lungs with no known cause, and ORJ-001's developer says it helps the damaged lining of the air sacs repair itself. The evidence so far comes from mice: with bleomycin lung injury, treated mice had less scar tissue, and a blood marker of lung damage, tenascin-C, was 529 ng/mL against 1,081 ng/mL untreated. In people it has only been tested in about 64 to 65 healthy volunteers, 49 of whom got the drug rather than placebo; injection-site redness was the main side effect, so whether it helps patients is not yet known.
ORJ-001 is a fully synthetic 19-amino-acid peptide, given under the skin as the acetate, found by phage display against human collagen types IV and VII and beta-1 integrin and then by screening in fibrotic mouse lungs. Its developers call it a selective beta-1 integrin (CD29) agonist with about 1,000-fold higher affinity for beta-1 than for other integrins, and say it triggers FAK signaling that restores the function of alveolar type 2 cells. NIBEC of South Korea discovered it as NP-201 and licensed it to Oorja Bio of Houston; Oorja says it acquired the global rights.
What it's used for
Nothing outside clinical trials. It is being tested as a twice-weekly injection for idiopathic pulmonary fibrosis in the ORBIT-IPF phase 2; the first patient was screened in October 2026.
How does ORJ-001 (NP-201) work?
What it does in the body, and where.ORJ-001 is designed to switch on beta-1 integrin, a receptor on the surface of lung cells, so that injured air sacs can rebuild; every step below comes from company lab and mouse work.
- 01Finding injured tissueThe peptide binds beta-1 integrin, also called CD29, with about 1,000-fold higher affinity than for other integrins on a company poster. The company says it prefers the receptor's primed state and that this state occurs in injured tissue; in mice, a labeled dose stayed in scarred lung from day 1 to day 7.
- 02Switching the receptor onBinding pushes the integrin into its active, extended shape and triggers FAK and AKT signaling. In A549 lung cells, the junction proteins E-cadherin, ZO-1 and occludin rose within 24 hours.
- 03Rebuilding the liningThe company says this restores alveolar type 2 cells and their ability to mature into the type 1 cells that line the air sacs. In fibroblasts in the lab, scar-related genes (COL1A1, TIMP2 and MMP13) fell. None of these steps has been shown in people.
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.
Mouse lung scarring
Early research- Animal studyMice with bleomycin lung injury given 30, 60 or 90 mg/kg under the skin twice weekly from day 7 to day 21 had less fibrotic area, lung collagen and Ashcroft scar score than untreated mice; the effect of the comparator, nintedanib, was not statistically significant. No numbers are given in the text.
- No dataCompany posters only, not peer reviewed.
Mouse blood markers and lung retention
Early research- Animal studyMice given 60 mg/kg weekly from day 28 of bleomycin injury: plasma tenascin-C 529 ng/mL against 1,081 untreated and 456 in healthy mice; SP-D 0.798 against 4.45 and 0.496 ng/mL.
- Animal studyA single labeled 60 mg/kg dose stayed in scarred lung, alongside beta-1 integrin, from day 1 to day 7; the poster calls this long target engagement but does not link it to a dosing schedule or half-life.
Healthy volunteers
Investigational- human-earlySingle doses of 100 to 400 mg (24 on the drug, 8 on placebo): any side effect in 100% against 62.5%, mostly at the injection site; one severe event at 400 mg; no serious events.
- human-earlyRepeated doses (25 on the drug, 8 on placebo): 2 of 7 on 200 mg daily stopped for side effects; no serious or severe events; no anti-drug antibodies in anyone.
- No dataLab, vital sign and ECG results were collected but not reported.
In patients
Investigational- No dataNo patient data exist yet. ORBIT-IPF plans about 95 adults, with change in FVC at week 12 as its main efficacy measure and primary completion estimated for January 2029.
- No dataOnly two US sites, in Doral, Florida, and DuBois, Pennsylvania, were listed as of October 2026.
The October 13, 2026, announcement is often reported as the start of dosing in the phase 2; it said the first patient had been screened, and the registry gives an estimated start of October 2026. The phase 1 work is often credited to Oorja Bio, but NIBEC sponsored both healthy-volunteer studies under the code NP-201 in Adelaide, Australia, and Oorja presented the data in May 2026. The figure of 64 healthy volunteers is the company's; the poster tables add up to 65 (32 in the single-dose study and 33 in the repeated-dose study, 49 of them on the drug) and the repeated-dose registry lists 35 enrolled, so about 64 to 65 across two studies is the safe description. 'No systemic toxicities' leaves out that 2 of 7 people on 200 mg daily stopped for side effects and that one severe event occurred at 400 mg. NIBEC said in 2023 that exposure rose in proportion to dose; the 2026 poster shows lower exposure at the 400 mg single dose and the 300 mg repeated dose and makes no claim of dose proportionality. Claims that it 'reverses fibrosis' and works 'significantly better than nintedanib or pirfenidone' rest on mouse studies, with no published numeric comparison and no pirfenidone arm on the poster, and the tenascin-C and SP-D falls are mouse blood results, not human ones. The phase 2 is described as multi-country, though only two US sites were listed as of October 2026. Funding is quoted as $30 million (May 2026, Westlake BioPartners alone) and $34 million (October 2026, with Andreessen Horowitz); the later figure is current. One trade outlet calls it a 'CD29 inhibitor', the opposite of the company's 'agonist' wording, since CD29 is beta-1 integrin itself; Oorja's own materials consistently say agonist. Its blood half-life is about half an hour, so the twice-weekly schedule is supported by mouse data, not a long half-life.
The published record
Papers and trials about ORJ-001 (NP-201)
2 papers tagged human · 0 not reviews or lab · 0 clinical trial publications
2 registered trials · none with posted results
Furthest stage reached: Phase 2, under way
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.
At a glance
Four things to know about ORJ-001 (NP-201)
Evidence
Investigational
Category
Healing and recovery
Common vial
Varies
Half-life
About 0.5 hours (26 to 36 minutes)
How much, and do you cycle it?
The range, and whether you take breaks.200 or 400 mg twice weekly (phase 2 trial), twice weekly (phase 2 trial). Continuous twice-weekly dosing in the phase 2 Trial dose
The phase 2 gives twice-weekly injections for 12 weeks with no planned breaks. Its blood half-life is about half an hour, so the schedule is supported only by mouse work, where twice-weekly dosing reduced scarring and the peptide stayed in scarred lung for up to 7 days, not by human data. No longer or cycled schedule has been tested.
How long does it stay in the body?
The half-life, and where the figure comes from.About 0.5 hours (26 to 36 minutes)Trial protocol
Apparent terminal half-life 0.440 to 0.595 hours after injection under the skin, similar across doses, with peak levels at 40 minutes to 1 hour and one circulating metabolite, M1. Blood sampling ran only to 12 hours. The twice-weekly trial schedule is not explained by blood levels; it matches the mouse studies, where the peptide stayed in scarred lung for up to 7 days. Bioavailability and the clearance route have not been disclosed.
Source: Oorja Bio, ATS 2026 phase 1 poster (board 405), healthy volunteers
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized ORJ-001 (NP-201) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Not studied in pregnancy or breastfeeding: the phase 2 excludes both, and no reproductive data have been released
- Not studied in patients under 40: the phase 2 enrolls adults aged 40 and over
- Not studied in people with pulmonary fibrosis who have never taken an approved antifibrotic drug such as nintedanib, pirfenidone or nerandomilast: the phase 2 excludes them
- Not studied in more advanced lung function loss: the phase 2 requires an FVC of at least 45% predicted and a DLCO of 25% to 90% predicted
- Use outside a clinical trial: it is not sold or approved anywhere
Stop and get help
- An injection site that becomes hot, very painful or keeps spreading: redness was seen in 91.7% after a single dose, so worsening, not redness itself, is the signal
- Sudden worsening of breathlessness or cough: tell the trial team, since the phase 2 tracks flare-ups of the disease and respiratory hospitalizations
Common effects
- Injection-site redness in 91.7% (22 of 24) after a single dose against 0% on placebo; injection-site pain in 50% of both groups
- Itching in 33.3% and swelling (edema) in 29.2% after a single dose, against 0% on placebo
- Over repeated doses, headache in 28% against 25% on placebo, with nausea and flushing each in 8% on the drug (no placebo rate given)
- Any side effect in 100% against 62.5% on placebo after single doses, and 96% against 75% over repeated doses; no serious events, and no one formed antibodies to the drug
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is ORJ-001 (NP-201) approved?
And where the numbers on this page come from.No. ORJ-001 (NP-201) is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked18 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesClinicalTrials.gov, ORBIT-IPF (NCT07869147)Oorja Bio, ORBIT-IPF phase 2 release (GlobeNewswire, October 13, 2026)Oorja Bio, phase 1 data release (GlobeNewswire, May 19, 2026)Oorja Bio, ATS 2026 phase 1 poster (board 405)Oorja Bio, ATS 2026 poster P169Oorja Bio, Pulmonary Fibrosis Foundation Summit poster (November 2025)ANZCTR, ACTRN12622001027707ClinicalTrials.gov, NCT06681389Oorja Bio, company launch release (May 19, 2026)Fierce Biotech, Oorja Bio launch (May 2026)BioWorld, NIBEC license (May 29, 2025)BioCentury, Oorja Bio venture coverage (2026)eToday, NIBEC phase 1 results (October 6, 2023)FDA GSRS, exact-name search for ORJ-001
What has happened recently
Not approved anywhere, and no orphan, fast track or breakthrough designation has been announced. NIBEC Co., Ltd. of Seoul discovered it and sponsored both phase 1 studies in healthy volunteers under the code NP-201, at CMAX Clinical Research in Adelaide, Australia: a single-dose study registered on July 22, 2022 (ACTRN12622001027707), and a repeated-dose study that ran from November 25, 2024, to September 4, 2025 (NCT06681389) and was terminated after Part A for strategic reasons, before its planned ulcerative colitis part. On May 28, 2025, NIBEC announced a license of NP-201 to an undisclosed US biotech worth up to $435 million. On May 19, 2026, the licensee was revealed as Oorja Bio of Houston. Oorja said it had acquired the global rights, had a US IND cleared and had raised a $30 million Series A from Westlake BioPartners; by October 13, 2026, the round was given as $34 million, with Andreessen Horowitz joining. The phase 2a/2b ORBIT-IPF (NCT07869147) was first posted on October 9, 2026, its first patient was screened by October 13, 2026, and primary completion is estimated for January 2029.
You can compare this against the whole library, or read how to check a seller.
What else is like ORJ-001 (NP-201)?
Others in Healing and recovery, side by side.If you're weighing ORJ-001 (NP-201), it's worth reading Palopegteriparatide (Yorvipath), Pentosan Polysulfate (PPS), and Plecanatide (Trulance) in the same class.
A synthetic 19-amino-acid peptide meant to switch on beta-1 integrin and help the lining of the lungs repair itself. Its phase 2 in pulmonary fibrosis screened its first patient in October 2026.
- Dose
- 200 or 400 mg twice weekly (phase 2 trial)
- How often
- Twice weekly (phase 2 trial)
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)
A daily constipation tablet that works inside the gut and barely reaches the blood.
- Dose
- 3 mg once daily (label)
- How often
- Once daily, with or without food
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.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- ClinicalTrials.gov, ORBIT-IPF (NCT07869147)(2026)Phase 2a/2b, estimated 95 adults with IPF; 200 or 400 mg twice weekly for 12 weeks against placebo; Part B primary endpoint is change in FVC at week 12.
- Oorja Bio, ORBIT-IPF phase 2 release (GlobeNewswire, October 13, 2026)(2026)First patient screened; twice-weekly injection for 12 weeks; $34 million Series A with Andreessen Horowitz.
- Oorja Bio, phase 1 data release (GlobeNewswire, May 19, 2026)(2026)64 healthy volunteers in single and repeated-dose studies; injection-site reactions most common; tenascin-C and SP-D falls in mice.
- Oorja Bio, ATS 2026 phase 1 poster (board 405)(2026)Doses, side-effect rates against placebo, no anti-drug antibodies; half-life 0.440 to 0.595 hours; peak at 40 minutes to 1 hour.
- Oorja Bio, ATS 2026 poster P169(2026)A labeled dose stayed in fibrotic mouse lung from day 1 to day 7; tenascin-C and SP-D values in mice.
- Oorja Bio, Pulmonary Fibrosis Foundation Summit poster (November 2025)(2025)Fully synthetic 19-amino-acid peptide, previously NP-201; phage-display origin; about 1,000-fold selectivity for beta-1 integrin; mouse bleomycin results against nintedanib.
- ANZCTR, ACTRN12622001027707(2022)NIBEC single-dose study of NP-201 acetate, 100 to 400 mg under the skin, healthy volunteers in Adelaide.
- ClinicalTrials.gov, NCT06681389(2025)NIBEC repeated-dose study, 35 enrolled; terminated after Part A for strategic reasons; the ulcerative colitis part never ran.
- Oorja Bio, company launch release (May 19, 2026)(2026)$30 million Series A from Westlake BioPartners; global rights acquired; US IND cleared.
- Fierce Biotech, Oorja Bio launch (May 2026)(2026)Formerly NP-201, discovered by NIBEC; May 2025 license worth up to $435 million.
- BioWorld, NIBEC license (May 29, 2025)(2025)NIBEC licensed NP-201 to an undisclosed US biotech in a deal worth up to $435 million.
- BioCentury, Oorja Bio venture coverage (2026)(2026)Formerly NP-201; describes it as a CD29 inhibitor, the opposite of the company's agonist wording.
- eToday, NIBEC phase 1 results (October 6, 2023)(2023)NIPEP-PF (trial code NP-201) single-dose results in 32 volunteers; planned US study in inflammatory bowel disease.
- FDA GSRS, exact-name search for ORJ-001(2026)No substance record: no UNII, formula or molecular weight.
Beyond these, 2 records are indexed. Browse the records