Becaplermin

• REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see Clinical Studies ( 14.2 ) ] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers.

• REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.contraindicated

REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use. The amount of REGRANEX to be applied depends upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2. Table 1: Formula to Calculate Length of Gel in Inches to Be Applied Daily Tube Size INCHES Formula 15 g tube length × width × 0.6 Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15 g tube. For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15 g tubes (1 x 2 x 0.6 = 1 1/4). Table 2: Formula to Calculate Length of Gel in Centimeters to Be Applied Daily Tube Size CENTIMETERS Formula 15 g tube length × width ÷ 4 Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15 g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 cm length of gel should be used for a 15 g tube [(4 x 2) ÷ 4 = 2]. The amount of REGRANEX to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area.

Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. ( 5.1 ) The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy. ( 5.1 ) 5.1 Risk of Cancer REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis [ see Clinical Pharmacology ( 12.1 ) ]. Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use [ see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 ) ]. The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy. 5.2 Application Site Reactions If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (e.g. patch testing) as dictated by clinical circumstances.

Erythematous rashes occurred in 2% of patients treated with REGRANEX. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Lynch Regenerative Medicine, LLC at 1-888-576-7343 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care), and none in subjects receiving good ulcer care alone. Subjects treated with REGRANEX did not develop neutralizing antibodies against becaplermin. In a retrospective follow-up study of 491 of 651 subjects (75%) from two randomized, controlled trials of another formulation of becaplermin gel 0.01%, the subjects were followed for a median of approximately 20 months to evaluate safety and recurrence of healed diabetic lower extremity ulcers. Eight of 291 subjects (2.7%) from the becaplermin gel group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval [CI], 0.6-12.8). The types of cancers varied and all were remote from the treatment site [see Warnings and Precautions ( 5.1 )] .

8.1 Pregnancy Risk Summary There are no available data on REGRANEX use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with REGRANEX. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation There are no data on the presence of becaplermin in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of REGRANEX to lactating women. The developmental and health benefits of breastfeeding should be considered along with the lactating woman's clinical need for REGRANEX and any potential adverse effects on the breastfed child from becaplermin. 8.4 Pediatric Use Safety and effectiveness of REGRANEX in pediatric patients below the age of 16 years have not been established. 8.5 Geriatric Use Among subjects receiving any dose of REGRANEX in clinical studies of diabetic lower extremity ulcers, 150 subjects were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

There are no data on the effects of REGRANEX overdose.

• Dec 16, 1997BLABLA103691Smith And Nephew

1. 1Abdominal Pain Lower1100%
2. 2Ammonia Increased1100%
3. 3Ascites1100%
4. 4Blood Glucose Increased1100%
5. 5Hepatic Cirrhosis1100%
6. 6Hepatic Encephalopathy1100%
7. 7Increased Tendency To Bruise1100%
8. 8International Normalised Ratio Increased1100%
9. 9Iron Deficiency Anaemia1100%
10. 10Lymphoma1100%
11. 11Pancytopenia1100%
12. 12Pleural Effusion1100%
13. 13Splenomegaly1100%
14. 14Thrombocytopenia1100%
15. 15White Blood Cell Count Decreased1100%

Recent PubMed references pinned to Becaplermin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• METTL3-catalyzed m6A modification of NSUN4 mediates m5C modification of SLC2A3 mRNA to regulate PDGF-BB-induced proliferation, hyaluronan production and glycolysis in human orbital fibroblasts.
  Journal of bioenergetics and biomembranes · 2026 · Liu SY, Wang H, Liu BZ, et al.
  PMID 42209904DOI 10.1007/s10863-026-10110-4
• PDGF-BB as a potential biomarker distinguishing major depressive disorder and bipolar depression.
  Journal of affective disorders · 2026 · Rosell-Cardona C, Kussberger J, Reif A, et al.
  PMID 41936983DOI 10.1016/j.jad.2026.121742
• Metformin inhibits PDGFβ signaling to suppress hyaluronan and cytokine production in thyroid eye disease.
  Experimental eye research · 2026 · Husain F, Patrick CC, Roztocil E, et al.
  PMID 41871797DOI 10.1016/j.exer.2026.110982
• PDGF-BB mitigates pericyte injury by activating the PHF19-PRC2 complex via the miR-221/BRCA1 signaling axis in Alzheimer's disease.
  Brain research bulletin · 2026 · Yang H, Zhou H, Zhao K, et al.
  PMID 41825614DOI 10.1016/j.brainresbull.2026.111819
• Refolding-free, tag-free production of functional platelet-derived growth factor-BB at gram-per-liter scale in Escherichia coli.
  Protein expression and purification · 2026 · Kim YS, Jeong H, Lee H, et al.
  PMID 41796946DOI 10.1016/j.pep.2026.106915
• Tubular cell-specific platelet-derived growth factor-B drives formation of fibrogenic niches in kidney fibrosis.
  Kidney international · 2026 · Klinkhammer BM, Buhl EM, Caspers T, et al.
  PMID 41765181DOI 10.1016/j.kint.2026.01.029
• Novel FGL2::PDGFD and TGFBI::PDGFB Fusions Expand the Molecular Spectrum of Dermatofibrosarcoma Protuberans.
  Genes, chromosomes & cancer · 2026 · Cloutier JM, Yakoub MA, Hameed M, et al.
  PMID 41711154DOI 10.1002/gcc.70110
• Microscale thermophoresis sensor for homogeneous and one-step protein detection based on dual aptamers binding induced DNA switch.
  Talanta · 2026 · Pang H, Zhao Q
  PMID 41702041DOI 10.1016/j.talanta.2026.129535

The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Becaplermin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rh-PDGF vs EMD for Treatment of Intra-bony Defects
  Recruiting · Phase 1 · Phase 2 · Interventional · 36 enrolled · Nova Southeastern University
  NCT05442034updated 2026-04-16
• Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
  Recruiting · Phase 2 · Interventional · 40 enrolled · Vanderbilt University Medical Center
  NCT06634030updated 2026-03-23
• Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
  Active not recruiting · Phase 2 · Interventional · 12 enrolled · Alexander Hawkins
  NCT06632418updated 2026-01-21
• Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor
  Recruiting · Interventional · 44 enrolled · University of Alabama at Birmingham
  NCT04954664updated 2025-12-29
• Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis
  Active not recruiting · Observational · 5 enrolled · University of Alabama at Birmingham
  NCT04964466updated 2025-12-02
• Fatty Liver and Pancreatic Steatosis
  Not yet recruiting · Observational · 61 enrolled · Maria Marta Piskorz
  NCT06757348updated 2025-08-06
• Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
  Active not recruiting · Interventional · 28 enrolled · Harvard Medical School (HMS and HSDM)
  NCT05576922updated 2025-04-10
• Reconstructive Therapy of Peri-implantitis with PDGF-BB (Gem-21)
  Completed · Phase 4 · Interventional · 11 enrolled · Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
  NCT06390124updated 2024-12-06
• A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
  Terminated · Phase 2 · Interventional · 63 enrolled · Ophthotech Corporation
  NCT02387957updated 2024-10-30
• Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB
  Withdrawn · Interventional · 0 enrolled · I-Ching Wang
  NCT06038695updated 2024-06-18

Frequently asked questions

What is Becaplermin used for?

According to FDA labeling, Becaplermin carries indications including: REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see Clinical Studies ( 14.2 ) ] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Becaplermin?

Becaplermin is classified as Other agents for local oral treatment, Other cicatrizants, Human Platelet-derived Growth Factor, Increased Epithelial Proliferation.

What are the brand names for Becaplermin?

Becaplermin is marketed under brand names including Regranex.

What are the contraindications for Becaplermin?

Becaplermin labeling lists contraindications including: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.. Always consult the full prescribing information and a clinician.